FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
A. Ibrahim Moss
Senior Vice President,
Self
Berkeley, CA, United States
ibrahim.moss@icloud.com
Abdul Rahim
Research Associate
Regeneron Pharmaceuticals
Tarrytown, NY, United States
abdul.rahim@regeneron.com
Abe Wong
VP QARA Global Quality
Phoenix Healthcare Solutions LLC
Ft. Lauderdale, FL, United States
abew@phoenix-hs.com
Abhijit Ramachandran
Director
AROG pharmaceuticals
Dallas, TX, United States
abhi.cogent@gmail.com
Abid Riaz Ahmed
Senior Scientist
Abbott Healthcare
Weesp, Non-US, The Netherlands
Abid.Ahmed@abbott.com
Adel Abou-Ali
Director Global Pharmacovigilance
Sanofi Pastuer
Toronto, Non-US, Canada
adel.abouali@gmail.com
Adil Gatrad
Quality Compliance
Actavis
Parsippany, NJ, United States
adil.gatrad@actavis.com
Aditi Patel
Regulatory Specialist
ClinicalRM
Frederick, MD, United States
aditiben.d.patel.ctr@mail.mil
Adriana Guerrero
Professional Assessor-Pharmacist
I.N.H.R.R.
Caracas, Non-US, Venezuela
adrianaguerrerorodriguez@gmail.com
Adriana Metz
Software Validation/Process QA Engineer
Sysmex America, Inc.
Lincolnshire, IL, United States
metza@sysmex.com
Affan Ali
Production Officer
Macter International Limited
Karachi, Non-US, Pakistan
affan.ali@macter.com
Aftab Modi
Sr Manager
USV Limited
Mumbai, Non-US, India
aftab.modi@usv.in
Ahmed El Desoky
Senior
Hikma pharma
Cairo, Non-US, Egypt
ahmed.desoky334@gmail.com
Ahmed Elsafy
R&D pharmacist
Hikma pharma
giza, Non-US, Egypt
a.elsafy177@gmail.com
Ahmed Mohamed
reasearch & development pharmacist
Hikma pharma
sixth of october, Non-US, Egypt
armedpharmacist@yahoo.com
Aisha Wellington
Regulatory Affairs Specialist
National Institites of Health
Rockville, MD, United States
aisha.wellington@nih.gov
Aishia Henderson
Study manager
Novum Pharmaceutical
Las Vegas, NV, United States
aishiah@gmail.com
Akil Foluke
Quality Assurance Associate
QOL Medical
Wayzata, MN, United States
afoluke@qolmed.com
Alan Martinson
President
Antigen Plus
Cabin John, MD, United States
customerservice@antigenplus.com
Alan Ramnath
Regulatory Coordinator
Emmes
Rockville, MD, United States
aramnath@emmes.com
Albert Deweese
Owner
Good Automation, LLC
Irving, TX, United States
jennifer.gray@goodautomation.com
Alejandro Hernandez
HEAD LABORATORY
PISA
GUADALAJARA, AL, Mexico
aljhernandez@pisa.com.mx
Aleksandra Eyring
Senior Clinical Research Coordinator
johns Hopkins University
Baltimore, MD, United States
aeyring1@jhmi.edu
Alex Chaharom
V.P. of Manufacturing Operations
GeNO LLC
Cocoa, FL, United States
alex.chaharom@genollc.com
Alexandra Mcpherron
Principal Scientist and Head of
Development
MyoTherapeutics
Silver Spring, MD, United States
amcpherron@myotherapeutics.com
Alicia Fitzpatrick
EHS Regulatory Manager
The Dow Chemical Company
Bristol, PA, United States
afitzpatrick@dow.com
Alexandra Trandafir
Regulatory Affairs Specialist
Profound Medical Inc.
Toronto, Non-US, Canada
atrandafir@profoundmedical.com
Alhanoof Alnafesah
student
MCPHS
Boston, MA, United States
m0258253@my.mcphs.edu
Alicia Plesnarski
Director Global RA Projects
Alcon
Ft. Worth, TX, United States
alicia.plesnarski@alcon.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Allen Panetz
President
BIOCHEMICAL DIAGNOSTICS
EDGEWOOD, NY, United States
allen@biochemicaldiagnostics.com
Allyson Anderson
Regulatory Affairs
Sciecure Pharma Inc.
Monmouth Junction, NJ, United States
allyson.anderson@sciecurepharma.com
Alyson Karesh
Team Leader
FDA
Silver Spring, MD, United States
alyson.karesh@fda.hhs.gov
Alyssa Roelli
Quality and Supply Chain Engineer
Medovations
Milwaukee, WI, United States
aroelli@medovations.com
Amale Hawi
Pharmaceutical Development Consultant
A. Hawi Consulting
Ridgefield, CT, United States
ahawi@ahawi.com
Amber Jones
Sr. Research Program Coordinator II
The Johns Hopkins University
Baltimore, MD, United States
ajones78@jhmi.edu
Amen Aradti
Manager
Pamedica
Plainview, NY, United States
amen.aradti@gmail.com
Amishkumar Patel
Research Scientist
FTF Pharma
ahmedabad, Non-US, India
amishpatel.ceutics@aol.in
Amit Goel
Senior Executive - Regulatory Affairs
Medico Electrodes International Ltd.
Noida, Non-US, India
amitgoel16987@gmail.com
Amit Sood
Sr. Officer
Sun Pharmaceutical Industries Limited
Chandigarh, Non-US, India
aamit26sood@gmail.com
Amy Cicatello
Quality Engineer
IMI
Pompano Beach, FL, United States
acicatello@imiweb.com
Amy Goley
Owner
Hot Work Consulting
Edmond, OK, United States
amygoley75@gmail.com
Amy Paukovits
Director of RA/QA
Gebauer Company
Cleveland, OH, United States
amy.paukovits@gebauer.com
Amy Piccini
Regulatory Affairs Manager
GF Health Products, Inc.
Atlanta, GA, United States
apiccini@grahamfield.com
Ana Karina Ulloa Verdín
Analyst Instrumental
Laboratorios PiSA S.A. de C.V.
Guadalajara, Non-US, Mexico
akulloa@pisa.com.mx
Ana Maria Saaibi
Sr QA Manager
NA
Miami, FL, United States
amsaaibi@gmail.com
Ana Ruiz
Solids Regulatory Affairs Head
Laboratorios Liconsa S.A.
Madrid, Non-US, Spain
ana.ruiz@chemogroup.net
Anan Copty
Founder and CEO
NIMD Ltd
Jerusalem, Non-US, Israel
anan.copty@NIMD-LTD.com
Ananda Kumar
President
Lambda Z Technologies, Inc.
Baltimore, MD, United States
akumar@lztinc.com
Andrea Vowell
Quality Consultant
Black Diamond Networks
Andover, MA, United States
andrea.vowell@gmail.com
Andreia Evora
Technical Writer
Johnson&Johnson
Schaffhausen, Non-US, Switzerland
aevora@its.jnj.com
Andres Garcia
Founder
Xone Labs Inc.
San Diego, CA, United States
andres@xonecom.com
Andrew Baumann
Staff Fellow
FDA
Silver Spring, MD, United States
andrew.baumann@fda.hhs.gov
Andrew Miller
Biomedical Engineer
FDA
Silver Spring, MD, United States
andrew.s.miller@fda.hhs.gov
Andrew Raven
Manager of Biostats Unit
Health Canada
Ottawa, Non-US, Canada
andrew.raven@hc-sc.gc.ca
Andrew Scothern
Quality Manager
Handicare
Allentown, PA, United States
andy.scothern@handicare.com
Andria Werynski
Associate Director, RA/QA
Cutanea Life Sciences
Wayne, PA, United States
awerynski@cutanealife.com
Angelica Rivas
Quality Director
MediStem Panama
Panama, Non-US, Panama
arivas@medistemresearch.com
Anibal Lopes
QA/QC Director
CiVentiChem
Cary, NC, United States
anibal@cvchem.com
Anjana Singh
Sr.Executive
Sentiss Pharma Pvt Ltd.
Gurgaon, Non-US, India
anjana@sentisspharma.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Ankara Yokum
Regulatory Business Process Manager
OPQ/CDER/FDA
Silver Spring, MD, United States
Ankara.Yokum@fda.hhs.gov
Ann Holt
QA Director
Andersen Products, Inc.
Haw River, NC, United States
aholt@anpro.com
Ann Howard
Reg Assoc
IGI LAbs
Buena, NJ, United States
ann123howard@igilabs.com
Ann Howard
Reg Assoc.
IGI labs
Buena, NJ, United States
annhoward@igilabs.com
Ann Marie Gaitan
Partner
Suarez Gaitan
Coral Gables, FL, United States
amg@suarezgaitanlaw.com
Ann Robards
Labeling Consultant
Eli Lilly and Company
Indianapolis, IN, United States
robards_ann_l@lilly.com
Ann Robbins
President
Ann Robbins LLC
Bradenton, FL, United States
annrobbins130@gmail.com
Anna Kirk
Regulatory Affairs Specialist
Siemens Medical Solutions, USA, Inc.
Knoxville, TN, United States
anna.kirk@siemens.com
Anna Lisa Somera
VP Quality and Regulatory Affairs
Innoblative
Chicago, IL, United States
als@innoblative.com
Anna Voght
Regulatory Affairs Project Manager
Perrigo
Minneapolis, MN, United States
anna.voght@perrigo.com
Anne Keane
Director of Regulatory Affairs
Achaogen
San Francisco, CA, United States
akeane@achaogen.com
Anne Tomalin
President
Therapeutic Products Inc.
Hamilton, Non-US, Canada
atomalin@tpireg.com
Anne-Laure Bailly
Consultant medical & regulatory
TechMD.fr
Paris, Non-US, France
albailly@techmd.fr
Annette Hormann
Regulatory and Clinical Affairs Manager
Baebies
Durham, NC, United States
ahormann@baebies.com
Annette Owens
Associate Director, RA
Professional Disposables International Inc
Montvale, NJ, United States
aowens@pdipdi.com
Annie Deogharia
President
Global Pharma Consultants, LLC
Lewis Center, OH, United States
global.pharmac@gmail.com
Antonio Olivo
Director
LSL
Chicago, IL, United States
antoniomiguelolivo@gmail.com
Anurag Patel
Manager
Dr. Reddy's Laboratories Inc.
Princeton, NJ, United States
anuragpatel@drreddys.com
April Krauss
Associate Director, Pharmacovigilance
UBC
Blue Bell, PA, United States
aprilkrauss@comcast.net
Arabindakshaya Mishra
DIRECTOR-DEVELOPMENT QUALITY
DR REDDYS LABORATORIES INC
BRIDGEWATER, NJ, United States
arabindakshyam@drreddys.com
Arahman Ghonemey
Project manager
JASPER
Zagazig, Non-US, Egypt
arahman_ghonemey@yahoo.com
Archana Shekher
Consultant
Consultant
Cary, NC, United States
dr.ashekher@aol.com
Ariela Alter
Vp clinical and regulatory
Brainq
Tel aviv, Non-US, Israel
Alterariela@gmail.com
Arshad Ali
Compliance office
Zafa Labortaories
Karachi, Non-US, Pakistan
arshadalizafa.aa@gmail.com
Artie Kaushik
Manager RA/QA
Gauss Surgical
Los Altos, CA, United States
artiekaushik@gmail.com
Artur Shchukin
Regulatory Compliance Specialist
Ampak
New York, NY, United States
shchukin.artur@gmail.com
Asaf Azulay
CEO
Top Li-Med Technologies LTD
Ramat Gan, IL, Israel
asaf@li-med.com
Asher Bazak
QA @ RA Manager
Brainsway
Jerusalem, IL, Israel
asherb@brainsway.com
Ashley Yeh
assistant scientist
Pharmadax Inc
Taipei, Non-US, Taiwan
ashley.yeh@pharmadax.com
Asis Sarkar
Director
Baylor College of Medicine
Houston, TX, United States
asissarkar3@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Audrey Zaweski
President
Peconic Regulatory Consulting LLC
Calverton, NY, United States
azaweski@peconicregulatoryconsultingllc.
net
Baban Bhalerao
Sr.Executive
Enem Nostrum Remedies Pvt. Ltd.
Mumbai, Non-US, India
bhaleraobaban@hotmail.com
Avinash Dewangan
ASSISTANT GENERAL MANAGER
AMNEAL PHARMACEUTICALS
AHMADABAD, Non-US, India
avinashd@amnealindia.com
Baban Bhalerao
Sr. Officer
Enem Nostrum Remedies Pvt. Ltd.
Mumbai, Non-US, India
baban.bhalerao@enemnostrum.com
Bala Kumar
Associate
Shasun Pharmaceuticals Limited
Puducherry, Non-US, India
balakumara@shasun.com
Balaji Gandhe
RA Project Manager
Perrigo Company Plc
New Hope, MN, United States
balajigandhe@gmail.com
Baishali Kanjilal
Deputy Director, Force Health Protection
Division
USAMMDA
Frederick, MD, United States
baishali.kanjilal.mil@mail.mil
Balaji Gandhe
RA Project Manager
Perrigo Company
New Hope, MN, United States
balaji.gandhe@perrigo.com
Baoying Liu
Health Scientist Administrator
NIH
Rockville, MD, United States
baoying.liu@nih.gov
Barbara Hanney
associate
Teva
Horsham, PA, United States
barbara.hanney@tevapharm.com
Barbara Ellison
VP, Quality
Elite Laboratories
Northvale, NJ, United States
bellison@elitepharma.com
Bart Waclawik
COO
AMD LASERS
Indianapolis, IN, United States
bart@amdlasers.com
Bashar Deeb
Product Surveillance Associate
CooperSurgical
Trumbull, CT, United States
bdeeb@yahoo.com
Becky Leibowitz
Associate Director
Janssen Pharmaceuticals
Raritan, NJ, United States
rleibowi@its.jnj.com
Ben Crowder
Director of Product Development
Chinook Medical Gear, Inc.
Durango, CO, United States
ben@chinookmed.com
Ben Harpster
QA Compliance Specialist
GlaxoSmithKline
Raleigh, NC, United States
Benjamin.E.Harpster@gsk.com
Benita Lanzer
Business Development VP
NE Field Diagnostics
Caesarea, Non-US, Israel
benitalanzer@gmail.com
Benjamin Kraus
head of manufacturing
Biofrontera
Leverkusen, Non-US, Germany
gmp.compliance@outlook.com
Benjamin Moses
General Manager
Marina Medical Instruments, Inc
Fort Lauderdale, FL, United States
ben@marinamedical.com
Betsy Woodall
Sr Mgr, Medical Information
Teva Pharmaceuticals
Frazer, PA, United States
betsy.woodall@tevapharm.com
Bev Stefanavage
Staff Engineer- Quality
Animas Corporation
West Chester, PA, United States
bstefan1@its.jnj.com
Beverly Folmer
Manager, Pharmaceutical Development
Incyte Corporation
Wilmington, DE, United States
bfolmer@incyte.com
Beverly Hillard
CRA
MedSource
Newington, CT, United States
Bhillard@medsource.com
Bhavana Arya
Sr. EHS Associate
Thermofisher scientifis
bangalore, Non-US, India
bhavanaarya18@gmail.com
Bill Blank
VP, Sales and Marketing
EveryClinicalTrial
Wilmington, NC, United States
bill.blank@everyclinicaltrial.com
Bnv Sambasiva Reddy
Asst Manager
Dr Reddys
Hyderabad, Non-US, India
sambasivarbnv@drreddys.com
Bobbi Siddoway
Regulatory Specialist
Total Joint Orthopedics
Salt Lake City, UT, United States
bsiddoway@tjoinc.com
Bolesh J. Skutnik
president/owner
BJA ASSOCIATES
West Hartford, CT, United States
boleshsj@aol.com
Botros Shameih
Responsible Pharmacist
Concept For Pharmacy
Kfar-sava, Non-US, Israel
botros@concept-rx.co.il
Baljinder Kaur
Deputy Manager
Nectar Lifesciences ltd
Chandigarh, Non-US, India
baljinder.pbiuniv@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Bradford Perry
Manager
Pacira
Parsippany, NJ, United States
brad.perry@pacira.com
Bria Beatty
Student Intern
FDA CDRH
Silver Spring, MD, United States
bria.beatty@fda.hhs.gov
Brian Mabie
Pharmacist in Charge
API
Waterford, MI, United States
bmabie@buyapi.com
Brian Mundo
Quality Manager
Orchid Orthopedic Solutions
Farmington Hills, MI, United States
brian.mundo@orchid-ortho.com
Bronwyn Mitchell
Executive Assit to the CEO / Quality Coord.
LW Scientific, Inc.
Lawrenceville, GA, United States
bronwynm@lwscientific.com
Bruce Wyka
CMC Regulatory Affairs
Insmed
Bridgewater, NJ, United States
bruce.wyka@insmed.com
Bunny Bierman
Regulatory Affairs Manager
Mallinckrodt
Hazelwood, MO, United States
bunny.bierman@mallinckrodt.com
Butros Hallac
CTO
NIMD
Jerusalem, IL, Israel
butros.hallac@nimd-ltd.com
Byron Arguello
Regulatory Affairs Associate II
Sandoz Inc
Wilson, NC, United States
byron.arguello@sandoz.com
Caini Liu
Project staff
Cleveland Clinic
Cleveland, OH, United States
liuc@ccf.org
Camille Billing
Regulatory Associate
Salvona Technologies
Hamilton, NJ, United States
cbilling@salvona.com
Carissa Black
Systems Engineer
Syncroness
Westminster, CO, United States
cblack@syncroness.com
Carla Alongi
QA Manager
CFA Services LLC
Morton Grove, IL, United States
cfaservicesllc@yahoo.com
Carla Duke
CEO
3 Point Medical
Sellersburg, IN, United States
operations@3pointmedical.com
Carlos Montoyo
Compliance Consultant
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
carlos.montoyo@dgfgroup1.com
Carmelita Varela
Sr. CRA
BioControl Medical
New Hope, MN, United States
cvarela@biocontrol-medical.com
Carmen Lam
Sr. RA Specialist
myoscience
Fremont, CA, United States
clam@myoscience.com
Carmen Cardona-Mejia
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
carmen.cardona-mejia@siemens.com
Carmen Netto-Merced
Regulatory Affairs Specialist
City of Hope
Duarte, CA, United States
cmerced@coh.org
Carol Bailey
Dir RA
OncoGenex
seattle, WA, United States
cbailey@oncogenex.com
Carol Chen
Business Development
Diassess
Berkeley, CA, United States
carol@diassess.com
Carol Griffin
Regulatory Scientist
The Clorox Company
Evansville, IN, United States
carol.griffin@clorox.com
Carol Kobrin
Director of External Regulatory Affairs
Johns Hopkins University
Baltimore, MD, United States
ckobrin@jhmi.edu
Carol Marchione
Vice President, Reg Affairs and QA
TetraLogic Pharmaceuticals
Malvern, PA, United States
carol.marchione@tlog.com
Carol Winfield
Director of Regulatory Operations
ISPE
Bethesda, MD, United States
cwinfield@ispe.org
Caroline Kissam
Reserach Manager
Upstate Cardiology
Greenville, SC, United States
ckissam@upstatecardiology.com
Carolyn Hoban
vp research
hhc heathcare
hartford, CT, United States
carolyn.hoban@hhchealth.org
Carolyn Pham
Manager
B. Braun Medical
Irvine, CA, United States
carolyn.pham@bbraun.com
Carrie Brancart
Dir. QA/RA
VIDAR Systems Corporation
Herndon, VA, United States
carrie.brancart@3dsystems.com
Carrie Cameron
VP, CRO Services
Clinlogix
Ambler, PA, United States
ccameron@clinlogix.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Carrie Voycheck
Biomedical Engineer
FDA
Silver Spring, MD, United States
carrie.rainis@fda.hhs.gov
Cat Bens
Quality Assurance Manager
Colorado State University
Ft Collins, CO, United States
cat.bens@colostate.edu
Catherine Chew
Deputy Director
FDA DDI
Silver Spring, MD, United States
catherine.chew@fda.hhs.gov
Catherine Williams
Director, Regulatory Affairs
Wako Life Sciences, Inc.
Mountain View, CA, United States
c-williams@wakousa.com
Celeste Lim
Regulatory Specialist
Allergan
Irvine, CA, United States
celeste.l.lim@gmail.com
Chad Gibson
Project Engineer
Regulatory and Quality Solutions, LLC
Columbus, OH, United States
cgibson@rqteam.com
Chahana Patel
Regulatory Affairs Specialist
ICU medical
Taylorsville, UT, United States
cpatel@icumed.com
Chander Kazipeta
Head - Global regulatory Affairs
airis PHARMA
Hyderabad, Non-US, India
kchander@airispharma.com
Chandra Mouli Dubey
Trainee
Shilpa Medicare
Raichur, Non-US, India
cmdubey2208@gmail.com
Chandrakanth Reddy Vulpala
managing director
flourssh cosmeti & wellbing clincs
hyderabad, Non-US, India
flourishhclinic@gmail.com
Chandrashaker Akula
Manager Validation
AMRI
Albany, NY, United States
chandrashaker.akula@amriglobal.com
Chao Hsiao
COO
Autotelic Inc.
CIty of Industry, CA, United States
chsiao@autotelicinc.com
Charles Celeste
Director, Reg Policy and Intel
LEO Pharma
Parsippany, NJ, United States
chris.celeste@leo-pharma.com
Changbin Hou
manager
GUANGZHOU RAINHOME PHARM & TECH
CO ., LTD
Guangzhou, Non-US, China
houchangbin@rhkj.com.cn
Charles Ditusa
Chief, Office of Quality Management
USAMMDA
Ft. Detrick, MD, United States
charles.a.ditusa.mil@mail.mil
Charles Lee
CEO
Molecular Matrix, Inc.
Davis, CA, United States
cclee@molecularmatrix.com
Charles Stankovic
Principal Scientist
Ash Stevens Inc
Riverview, MI, United States
cstankovic@ashstevens.com
Charly Duffy
Quality and Regulatory Supervisor
Swissray International, Inc
Piscataway, NJ, United States
charlyann.duffy@swissray.com
Chaudhry Tajammal Hussain
Quality Systems and Standard head
Novartis Pharma
Karachi, Non-US, Pakistan
tajammal.s.hussain@hotmail.com
Chelsea Cabral
chemist
Queen's Medical Center
Honolulu, HI, United States
ccabral@queens.org
Chen Hsiao Lu
Marketing Durector
Covalence Biotechnology Co.,Ltd
Taipei, Non-US, Taiwan
wcc1125@gmail.com
Chen Suen
Program director
National Cancer Institute
Poolesville, MD, United States
chen.suen@nih.gov
Chenguang Wang
Assistant Professor
Johns Hopkins Univ
Baltimore, MD, United States
cwang68@jhmi.edu
Cheryl Revels
Research Coordinator
Marshfield Clinic
Marshfield, WI, United States
revels.cheryl@marshfieldclinic.org
Cheryl Zellmer
Sr. Int'l Trade Compliance Analyst
Medtronicq
Minneapolis, MN, United States
cheryl.s.zellmer@medtronic.com
Chien-Hsiang Tang
R&D Director
Lihpao Life Sci. Co.
Taipei, Non-US, Taiwan
ch.tang@anawrahta.com.tw
Chien-Hui Yang
Regulatory Affair Associate
Inova Diagnostics
San Diego, CA, United States
gyang@inovadx.com
Chiung Fang Peng
CEO
FUGA BIOTECHNOLOGY CO
TAIPEI, Non-US, Taiwan
LILY@FUGA.COM.TW
Chorom Pak
Cancer Biologist
Cellectar Biosciences, Inc
Madison, WI, United States
cpak@cellectar.com
Chris Chan
Sr. engineer
ITRI
Hsinchu, Non-US, Taiwan
cchan@itri.org.tw
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Chris Fowler
Owner
Chris Fowler, LLC
Newtown, CT, United States
Cfowler@consultcf.com
Chris Goodpaster
QC Specialist II
ISTO Technologies
St. Louis, MO, United States
cgoodpaster@istotech.com
Chris Sasiela
Regulatory Specialist
NHLBI / NIH
Bethesda, MD, United States
chris.sasiela@nih.gov
Christelle Laot
Technical Fellow
FedEx Express
Memphis, TN, United States
christelle.laot@fedex.com
Christin Lydon
Regulatory Affairs Associate
Curis, Inc.
Lexington, MA, United States
clydon@curis.com
Christina Copley
Quality Engineer
Oncore
San Marcos, CA, United States
christina.copley@oncorems.com
Christina Miracle
Manager of Regulatory Compliance
Cincinnati Sub-Zero
Cincinnati, OH, United States
cmiracle@cszinc.com
Christina Thompson
Quality
Alvix Laboratories
Ocean Springs, MS, United States
CThompson@alvix.com
Christine Lee
Data Assistant
KCRN Research
Germantown, MD, United States
christinelee@kcrnresearch.com
Christine Lewczuk
Co-Founder, Director ClinOps
RESEARCH ECHO
Toronto, Non-US, Canada
ckl@research-echo.com
Christine Miller
VP Regulatory Affairs
TherapeuticsMD
Boca Raton, FL, United States
christine.miller@therapeuticsmd.com
Christine Oswald Tigerman
CRA II
Abbvie/Inventiv
Pacifica, CA, United States
c.tigerman@yahoo.com
Christoph Görlach
Director Preclinical and clinical R&D
Geistlich
Wolhusen, Non-US, Switzerland
goerlach@geistlich.ch
Christopher Cover
Founder and CEO
Crescentium, LLC
New Orleans, LA, United States
christopher.cover@crescentium.com
Christopher Kent
President & CEO
ODS Medical
Montreal, Non-US, Canada
chriskent@odsmed.com
Christopher Medberry
Senior Regulatory Affairs Specialist
J&J
West Chester, PA, United States
medberry.christopher@synthes.com
Christopher Rao
Project Manager
Clinical Assistance Programs, LLC
Framingham, MA, United States
crao@captrials.com
Cindi Linville
Director of Quality
Best Sanitizers
Walton, KY, United States
clinville@bestsanitizers.com
Cindy Lopez
Associate Director, Regulatory Affairs
Regulatory Professionals. Inc
Newark, CA, United States
cindy.lopez@regprofessional.com
Cindy Martin
Director, RA
Aerie Pharmaceuticals, Inc.
Irvine, CA, United States
cmartin@aeriepharma.com
Claudia Sanchez
CHIEF OF LABORATORY
LABORATORIOS PISA FARMACEUTICA
GUADALAJARA, Non-US, Mexico
Clasanchez@pisa.com.mx
Claudia Jackson
Regulatory Affairs Specialist
Honeywell HomMed
Brookfield, WI, United States
claudia.jackson@honeywell.com
Claire Murphy
Associate Consultant
Tecno-med Ingenieros Medical Tech
Consultants
Barcelona, Non-US, Spain
cmurphy@tecno-med.es
Claudine Ashvar
Consultant, CMC
na
SC, CA, United States
cashvar@yahoo.com
Claus-Peter Richter
CTO
Resonance Medical, LLC
Evanston, IL, United States
cri529@northwestern.edu
Clifton Stanfill
V.P. Regulatory Affairs
AvKARE, Inc
Pulaski, TN, United States
cstanfill@avkare.com
Colleen Gang
Product Manager
BIOCHEMICAL DIAGNOSTICS
EDGEWOOD, NY, United States
CGANG@BIOCHEMICALDIAGNOSTICS.COM
Corey Olson
Quality and Regulatory Associate
Medovations
Milwaukee, WI, United States
colson@medovations.com
Cris Lebrilla
Director, Quality Assurance
C3 Jian, Inc.
Marina del Rey, CA, United States
clebrilla@c3-jian.com
Crystal Lewis
Consumer Safety Officer
FDA/CDH
Silver Spring, MD, United States
Crystal.lewis@fda.hhs.gov
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Daisy Devi
Senior Associate
Thermo Fisher Scientific
Bangalore, Non-US, India
daisy.devi@thermofisher.com
Daisy Rani Devi
Labeling Administrator
Thermo Fisher Scientific
Bangalore, Non-US, India
daisee@gmail.com
Daljit Gill
Senior Consultant
DNH Group LLC
Newark, DE, United States
dgill@dnhgroupllc.com
Dallas Kemper
Quality Engineer & FDA Official
Correspondent
Thermo Fisher Scientific
Marietta, OH, United States
dallas.kemper@thermofisher.com
Daneris Fernandez
President
DGF Group
San Juan, Non-US, Puerto Rico
daneris.fernandez@dgfgroup1.com
Damaris Flores Neris
Document Controls Technical Writer
Janssen Pharmaceutical
Guaynabo, PA, Puerto Rico
dflore11@its.jnj.com
Dana Prieto
Quality Control
Alvix Laboratories LLC
Ocean Springs, MS, United States
DPrieto@Alvix.com
Daniel Dafonseca
Regulatory Analyst
University Of Miami
Miami, FL, United States
moisaniel@gmail.com
Daniel Joung
Director of Sales and Marketing
Megabio Implant Solutions
Anaheim, CA, United States
director@megabiousa.com
Daniel Molina
VP, Strategic Planning
TRI, Inc
Bethesda, MD, United States
dmolina@tech-res.com
Daniela Beccati
Director of Analytical Research and Quality
OLivo Labs
Cambridge, MA, United States
dbeccati@livingproof.com
Danielle Quinn
Quality Manager
VLV Associates
East Hanover, NJ, United States
dq@associates.com
Danny Even-Chen
Q&R Senoir Director
Philips
Haifa, Non-US, Israel
danny.even-chen@philips.com
Darcy Difede
Director of Research
University Of Miami - ISCI
MIami, FL, United States
ddifede@miami.edu
Darcy Teagle
Senior Quality Assurance Specialist
CD Diagnostics
Claymont, DE, United States
dteagle@cddiagnostics.com
Darius Daruwala
Manager Regulatory Affairs
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
darius.daruwala@siemens.com
Darren Reeves
President
DPDC, LLC
Moseley, VA, United States
dreeves@dpdconline.com
Dave Greco
QC Senior Manager
The Mentholatum company
Orchard Park, NY, United States
greco@mentholatum.com
David Compton
Lead - Toxicologist
Sanofi US
Bridgewater, NJ, United States
david.compton@sanofi.com
David Crook
President
Innovapaedics
Mineola, TX, United States
dcrook@innovapaedics.com
David Hernandez
Director Regulatory Affairs
Chemo Group
Chatham, NJ, United States
dhernandez@chemogroup.net
David Jones
FDA SME
59th MDW/ST
Lackland, TX, United States
david.jones.219.ctr@us.af.mil
David Julovich
Research Specialist
UNTHSC
Fort Worth, TX, United States
david.julovich@unthsc.edu
David Kuchta
QA Mgr
QuadPharma LLC
Clarence, NY, United States
dkuchta@qdpharma.com
David Pellicciarini
Vice President, RA/QA/EHS
IBA Molecular North America, Inc.
Los Angeles, CA, United States
david.pellicciarini@ibamolecular.com
David Kouchoukos
Director, Combination Products Center of
Excellence
Janssen Pharmaceuticals
Horsham, PA, United States
dkouchou@its.jnj.com
David Salirrosas
EVALUATOR PHARMACEUTICAL CHEMICAL
DIGEMID-PERU
LIMA, Non-US, Peru
dsalirrosasl@gmail.com
David Weinstock
Attorney
Law Office of David S Weinstock
Weston, CT, United States
davidsw@optonline.net
David Wright
Senior Director, Regulatory Affairs
Kowa Research Institute
Morrisville, NC, United States
dwright@kowaus.com
Dawn Carter
Senior Manager of Medical Device
Compliance
MEDHOST
Franklin, TN, United States
dawn.carter@medhost.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Dawn Cottar
Consultant
Consultant
Bedford, TX, United States
dawncottar@yahoo.com
Dawn Defazio
Director Regulatory Affairs
ASRI
Pittsburgh, PA, United States
ddefazio@wpahs.org
Dawn Irons
Systems Engineer
EMC
Springfield, PA, United States
dawn.irons@emc.com
Dawn Li
Sr. Regulatory Specialist
Patterson Companies Inc.
Saint Paul, MN, United States
dawn.li@pattersoncompanies.com
Dawn Spooner
Associate Director
PerkinElmer
Waltham, MA, United States
dawn.spooner@perkinelmer.com
Dean Nahman
Medical R@D director
PortSight
Tel avi, Non-US, Israel
Deannahman@gmail.com
Deb Evans
Recent PhD
Recent Graduate
Bethesda, MD, United States
deb.evans451@gmail.com
Debasish Dwibedi
ASSISTANT MANAGER
SEMLER RESEARCH CENTER
BANGALORE, Non-US, India
debasishdwibedi@gmail.com
Debbie Kosiak
Global QA Manager
Havpak, Inc.
Malvern, PA, United States
dkosiak@havpak.com
Debleena Sinha
Regulatory Affairs Position
Implant Direct LLC
Agoura Hills, CA, United States
debleena.sinha@implantdirect.com
Deborah Kearney
CEO
SideX
Pittsburgh, PA, United States
dksafework@aol.com
Deborah Crandall
Attorney
Crandall & Assoc
Bethesda, MD, United States
Crandalllaw@yahoo.com
Deborah Freeman
Research Data & Regulatory Coordinator
Phoebe Putney Memorial Hospital
Albany, GA, United States
dfreeman@ppmh.org
Debra Bergstrom
Science Program Analyst
NIH
Bethesda, MD, United States
bergstrd@ninds.nih.gov
Debra Dow
President
Dow Development Laboratories
Petaluma, CA, United States
ddow@symbioresearch.com
Derajram Benival
Scientist
HLL Lifecare Limited
Trivendrum, Non-US, India
benivalderaj@gmail.com
Deval Patel
Regulatory affairs Manager
Astral Steritech pvt ltd
Ladera Ranch, CA, United States
deval.p1@gmail.com
Devasena K
Technical manager
Hcl
Chennai, Non-US, India
Kdevasena@hcl.com
Devendra Sharma
SR. GENERAL MANAGER
NECTAR LIFESCIENCES LIMITED
CHANDIGARH, Non-US, India
devendra.sharma@neclife.com
Devendra Kumar Sharma
SR. GENERAL MANAGER
NECTAR LIFESCIENCES LIMITED
CHANDIGARH, Non-US, India
dsharma.com@gmail.com
Devendra Sharma
Senior Genral Manager
Nectar Lifesciences Limited
Chandigarh, Non-US, India
dk_neclife@outlook.com
Devika Singh
Chief Product Officer
New Prometheus
Bethesda, MD, United States
deviks@gmail.com
Devraj Chakravarty
Manager Regulatory Affairs
Shionogi Inc
Florham Park, NJ, United States
dchakrav@gmail.com
Dharmesh Patel
HEAD REGULATORY AFFAIRS
ATUL LIMITED
ATUL, Non-US, India
dharmesh_ppatel@atul.co.in
Dharmesh Patel
Head Regulatory Affairs
Atul Limited
Atul, Non-US, India
dharmesh_ppatel2004@yahoo.co.in
Dharmil Patel
Regualatory Affairs and Quality Assurance
Pharbest Pharmaceuticals
Farmingdale, NY, United States
dharmil1991@gmail.com
Diana Parra
Student
Student
Pittsburgh, PA, United States
daparraf@gmail.com
Diana Sloane
Senior Associate
Lachman Consultant Services, Inc.
Westbury, NY, United States
d.sloane@lachmanconsultants.com
Diana Francis
Vice President, Global Quality
&Compliance
Medivation Inc
San Francisco, CA, United States
diana.francis@medivation.com
Diane Fassbender
Project Manager, Pharmacovigilance
United BioSource Corp
Blue Bell, PA, United States
diane.fassbender@ubc.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Diane Fisher
Regulatory Affairs Sr. Manager
Accenture
Berwyn, PA, United States
Diane.m.Fisher@accenture.com
Diane Marks
Associate Director, RA
Adaptimmune
Philadelphia, PA, United States
diane.marks@adaptimmune.com
Diane Nell
CSO
FDA
Silver Spring, MD, United States
diane.nell@fda.hhs.gov
Diane Tarapata
International Regulatory Associate
Church & Dwight Co Inc.
Princeton, NJ, United States
diane.tarapata@churchdwight.com
Dianne Schuetz
SVP, Operations
Force Diagnostics, Inc.
Bannockburn, IL, United States
dianne.schuetz@forcediagnostics.com
Dilip Parikh
President
DPHARMA GROUP INC.
ELLICOTT CITY, MD, United States
dpharma@gmail.com
Dimple Bommanaboina
Regulatory
Citron Pharma
East Brunswick, NJ, United States
dimple@citronpharma.com
Dinesh Anugu
Regulatory Affairs Associate
Insys Therapeutics
Chandler, AZ, United States
danugu@insysrx.com
Donald Johnson
Vice President
Pharmaceutics International, Inc.
Hunt Valley, MD, United States
donjohnson29@hotmail.com
Donna Coppenhaver
Manager, Regulatory Affairs & Compliance
WellSpring Pharmaceuitcal Corporation
Sarasota, FL, United States
dcoppenhaver@wellspringpharm.com
Dnyaneshwar Gawade
Manager -Training & Development
Sun Pharmaceutical Industries Ltd
Industrial Area III, AB Road, Dewas,
Madhya Pradesh (India) – 455001, Non-US,
India
Donna
Djinovich
dnyaneshwar.gawade@sunpharma.com
regulatory director
rauland
mount prospect, IL, United States
donna.djinovich@rauland.com
Donna Headlee
C sO
FDA
Silver spring, MD, United States
ddheadlee02061254@comcast.net
Donna Headlee
Consumer Safety Officer
FDA
Silver Spring, MD, United States
donna.headlee@fda.hhs.gov
Donna Pyne
Software QA
Neuronetics Inc
Malvern, PA, United States
dspyne@gmail.com
Donna Sade
Regulatory Representative
Eastman Chemical Company
Kingsport, TN, United States
dsade@eastman.com
Dorit Winitz
VP Regulatory and Clinical Affairs
Medial Cancer Screening Ltd
Kfar Malal, Non-US, Israel
dorit@medialcs.com
Douglas Bueschel
Vice President of Quality Assurance
Rapid Pathogen Screening
Sarasota, FL, United States
bueschel@rpsdetectors.com
Douglas Dumont
AIMBE Scholar
AIMBE
White Oak, MD, United States
dmd@alumni.duke.edu
Dov Gal
VP RA QA CA
ClearFlow
Anaheim, CA, United States
dov_gal@yahoo.com
Dr Rakesh Sonawane
Resident Doctor
Gandhi Medical College,Bhopal
Bhopal, MA, India
drrakeshsonawane@gmail.com
Dr.Gandham Shanthi Kumar
hospital management
flourissh slimming & cosmewtic wellbing
center
hyderabad, Non-US, India
gandhamshanthi@gmail.com
Dustin Rush
Production Manager
IONflow
Marina Del Rey, CA, United States
dustin@ionflow.com
Drew Jackl
VP
Custom Assemblies
Pine Level, NC, United States
drew.jackl@customassemblies.com
Drugaprasad Erukulla
Regulatory Affairs
Mylan laboratories Limited
Hyderabad, Non-US, India
Durgaprasad.Erukulla@mylan.in
Dylan Alu
Regulatory Coordinator
Drucker Diagnostics
Philipsburg, PA, United States
dylan.alu@druckerdiagnostics.com
E Mitchell Seymour
Regulatory Project Manager
University of Michigan
Ann Arbor, MI, United States
mitchell.seymour@gmail.com
Earleen Parks
Regulatory Affairs Manager
Remel Inc. (part of Thermo Fisher
Scientific)
Lenexa, KS, United States
earleen.parks@thermofisher.com
Eberth Sarmiento Infantes
EVALUATOR
MINISTERIO DE SALUD
LIMA, Non-US, Peru
esarmiento@digemid.minsa.gob.pe
Edmond Gosda
Consultant
Validant
Clark, NJ, United States
edmond.gosda@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Edna Makau
Regulatory Affairs Project Manager
Accenture
Berwyn, PA, United States
edna.makau@accenture.com
Eduard Benetskiy
Project Manager
OncoTartis LLC
Moscow, Non-US, Russian Federation
eduardben@mail.ru
Edzel Escala
Quality Manager
Garaventa Canada Ltd.
Surrey, Non-US, Canada
eescala@garaventaift.com
Efrem Borga
QA MANAGER
On-X LTI
AUSTIN, TX, United States
eborga@onxlti.com
Eileen Daloia
Director Regulatory Affairs
Crown Laboratories
Johnson City, TN, United States
edaloia@crownlaboratories.com
Elad Fein
Ceo
iFeel Labs
nofit, Non-US, Israel
eladfein@gmail.com
Elaine Berry
Sr. Regulatory Scientist
The Emmes Corporation
Rockville, MD, United States
eberry@emmes.com
Eimy Araque
Pharmacist I
Instituto Nacional de Higiene "Rafael
Rangel"
Caracas, Non-US, Venezuela
eimy_1718@hotmail.com
Eleanor Panico
Regulatory Consultant
Innovative Science Solutions
Jersey City, NJ, United States
panico.eleanor@gmail.com
Eleanore Dias
Regulatory Affairs Specialist
Mortara Instrument
Milwaukee, WI, United States
eleanore.dias@mortara.com
Elena Renaud
Sr. Maneger Reg. Affairs
Insys Theurapeutics
Chander, AZ, United States
erenaud@insysrx.com
Elijah Wreh
Regulatory Affairs Manager (Pre-Market)
Invacare Corporation
Elyria, OH, United States
ewreh@invacare.com
Elizabeth Brock
Quality Systems Manager
MEDTOX Diagnostics, Inc.
Burlington, NC, United States
bbrock@medtoxdiagnostics.com
Elias Mallis
Director, Division of Industry and
Consumer Education
U.S. Food and Drug Administration
Silver Spring, MD, United States
elias.mallis@fda.hhs.gov
Elizabeth Leffel
President
Leffel Consulting Group, LLC
Berryville, VA, United States
beth@leffelconsultinggroup.com
Elizabeth Mason
Manager, Regulatory Affairs
Haemonetics Corporation
Covina, CA, United States
elizabeth.mason@haemonetics.com
Elizabeth Noble
Owner
Elizabeth P. Noble,Inc.
Salisbury, NC, United States
elizabethpnobleinc@carolina.rr.com
Elizabeth Ottinger
Senior Project Manager
NIH/NCATS
Rockville, MD, United States
ottingerea@mail.nih.gov
Elizabeth Ripley
Clinical Research Compliance Officer
Virginia Commonwealth University
Richmond, VA, United States
elizabeth.ripley@vcuhealth.org
Elizabeth Rosenkrands-Lange
Manager
LEO Pharma Inc.
Parsippany, NJ, United States
elizabeth.rosenkrands-lange@gmail.com
Elizabeth Sherman
Manager of QA and Regulatory
Bell International Laboratories
Minneapolis, MN, United States
e.sherman@bellintlabs.com
Elizabeth Rosenkrands-Lange
Manager
LEO Pharma Inc.
Parsippany, NJ, United States
elizabeth.rosenkrands-lange@leopharma.com
Ellen Camos
Director, Regulatory Affairs
ANI Pharmaceuticals
Baudette, MN, United States
ellen.camos@anipharmaceuticals.com
Eman Ayyub
CEO
JiA pharma international
Stoneham, MA, United States
eman_pharma70@hotmail.com
Emily Morris
Clinical and Regulatory Associate
Medicines360
San Francisco, CA, United States
emorris@medicines360.org
Emily Vanhassel
Associate Director of Regulatory Affairs
Tetraphase Pharmaceuticals, Inc.
Watertown, MA, United States
evanhassel@tphase.com
Erez Hazan
QA
sion biotext
HAgosrim, Non-US, Israel
erezh@sn-medical.com
Eric Drupals
Clinical Research Consultant
Medcon Consulting
BEACONSFIELD, Non-US, Canada
edrupals@medconconsulting.com
Eric Joseph
Assc Director, Regulatory Affairs
Chattem
Chattanooga, TN, United States
eric.joseph@chattem.com
Elvia Gustavson
Senior Regulatory Affairs Consultant
Jeff Yuen & Associates
San Juan Capistrano, CA, United States
egustavson@jeffyuen.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Eric Sellke
Biomedical Engineer
Spectral MD
Dallas, TX, United States
sellke@spectralmd.com
Eric Song
quality director
sagent china pharmaceuticals
chengdu, Non-US, China
qsong@sagentchina.com
Erica Kontson
Product Engineer
Little Sparrows Technologies
Boston, MA, United States
erica@littlesparrowstech.com
Erica Nicoll
Regulatory Compliance Specialist
Novum Pharmaceutical Research Services
Pittsburgh, PA, United States
elnicoll@novumprs.com
Erica Wright
Engineer
InGeneron
Houston, TX, United States
ewright@ingeneron.com
Erika Crowley
QS Compliance Analyst
Fresinius Medical Care
Waltham, MA, United States
erika.crowley@fmc-na.com
Erin Mcfiren
Investigator
FDA
Baltimore, MD, United States
erin.mcfiren@fda.hhs.gov
Erin Quencer
Regulatory Analyst
FDA/CDRH
Silver Spring, MD, United States
erin.quencer@fda.hhs.gov
Ettore Amato
M.Sc.
University of Milan
Milan, Non-US, Italy
ettore.amato@unimi.it
Eugene Borrelli
Quality Assurance Specialist
IBA Molecular
Sterling, VA, United States
Eugene.Borrelli@ibamolecular.com
Eva Chin
CSO
MyoTherapeutics
Silver Spring, MD, United States
erchin@myotherapeutics.com
Evan Maddocks
Quality Manager
Advanced Instruments, Inc
Norwood, MA, United States
evanm@aicompanies.com
Ewa Kaczanowska
Regulatory Manager
BTE Technologies, Inc.
Hanover, MD, United States
ekaczanowska@btetech.com
Faisal Abbas
Quality Assurance Manager
Tabros Pharma
karachi, Non-US, Pakistan
faiceee@gmail.com
Faiz Ullah Khan
R&D
PharmEvo.Pvt.Ltd
Karachi, PA, Pakistan
Fuuastian.fz9@hotmail.com
Farhan Ayub
Asst. Manager Validation
Genix Pharma (pvt.) Ltd.
Karachi, Non-US, Pakistan
farhan.ayub07@gmail.com
Felix Morales
Quality Assurance Manager
Navajo Manufacturing Company Inc.
Denver, CO, United States
fmorales@navajoinc.com
Florence Nacino
CEO
V Manufacturing & Logistics Inc.
Walnut, CA, United States
fnacino@vmlcosmetics.com
Fathima Javeed
Manager of Regulatory Operation and
Quality Control
Cerecor Inc.
Baltimore, MD, United States
fathima.javeed@gmail.com
Flor Del Pilar Arana Sanchez
Senior Director Regulatory Affairs &
Compliance
KLOX Technologies Inc
Montreal, Non-US, Canada
farana@kloxtechnologies.com
Forest Ford
CSO
FDA
Silver Spring, MD, United States
forest.ford@fda.hhs.gov
Frank Mondoro
Director, Quality & Compliance
JLL
Kenilworth, NJ, United States
Frank.Mondoro@am.jll.com
Fred Defesche
President
RegCon Solutions LLC
San Diego, CA, United States
fdefesche@regconsolutions.com
Fred Mcbee
President
Focus Health Group
Knoxville, TN, United States
fred@focushealthgroup.com
Fred Weiss
Vice President of Quality
IGI Labs, Inc.
Buena, NJ, United States
fredweiss@igilabs.com
Frederick Golec
president
CMCRegAff LLC
merion station, PA, United States
golec@CMCRegAff.com
Frida Grynspan
nager
Stem Cell Medicine Ltd
jerusalem, Non-US, Israel
frida@stemcell-medicine.com
Fernando Sanchez
Sr. Compliance Auditor
Johnson & Johnson
Irvine, CA, United States
fsanch34@its.jnj.com
Flora Gilde
validation engineer
TORNIER
Montbonnot, Non-US, France
flora.gilde@tornier.com
Francisco Franco
President
Dentimed Sao Joao LLC
Sunrise, FL, United States
arojas.dentimedusa@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Gabriela Gottlieb
Regulatory Manager
Maxx Orthopedics, Inc
Plymouth Meeting, PA, United States
gabriela.gottlieb@maxxortho.com
Gaetano Rizzo
Manager, QA and Regulatory
iuvo BioScience
Rush, NY, United States
gaetano.rizzo@iuvobioscience.com
Ganga Kolli
Sr.Regulatory Affairs Specialist
USEndoscopy
Mentor, OH, United States
ganga_kolli@usendoscopy.com
Geanie Umberger
Associate Dean for Engagement and
Clinical Professor
Purdue University
West Lafayette, IL, United States
gumberger@purdue.edu
Geetha Jayan
SSHA
CDRH/FDA
White Oak, MD, United States
geetha.jayan@fda.hhs.gov
Geeta Routray
Manager
Piramal Enterprises Limited
Mumbai, Non-US, India
geeta.routray@piramal.com
Geetaram Sahu
Research Scientist
George Washington University
Washington, DC, United States
sahugr@yahoo.com
Gene Kulon
Quality Manager
Golden Technologies, Inc
Old Forge, PA, United States
gkulon@goldentech.com
Genoa Atwood
Quality
Span Packaging Services
Greenville, SC, United States
gatwood@spanps.com
George Chaux
Engineer
Captiva Spine
Jupiter, FL, United States
george.chaux@captivaspine.com
George Hellman
self-employed
none
San Diego, CA, United States
hellman1519@yahoo.com
George Plopper
Lead Associate, Regulatory Science
Booz Allen Hamilton
Rockville, MD, United States
Plopper_George@bah.com
Gerald Collins
CEO
Treadwell Corporation
Wilmington, NC, United States
g.collins@treadwellness.com
Gerardo Mendoza
Chromatography Analyst
Pisa Farmaceutica
Tlajomulco de Zuñiga, Non-US, Mexico
Gmendoza@pisa.com.mx
Gillian Miller
Snr Regulatory Scientist
Emmes
Rockville, MD, United States
gmiller@emmes.com
Gina Rivera
Quality Managment System
MEDICA D
Mexico City, Non-US, Mexico
ginal1987@hotmail.com
Giorgio Bonmassar
Ass Professor
MGH
Charlestown, MA, United States
gbonmassar@partners.org
Giridhar Prasad Jangly
Regulatory Associate
Dr. Reddy's Laboratories Inc.
Princeton, NJ, United States
gjangly@drreddys.com
Girish Koni
Scientist/Chemist
Guardian Drug Company
Dayton, NJ, United States
konigirish@yahoo.co.in
Gladys Martin
Regulatory Affairs Manager
Romark Laboratories, L.C.
Tampa, FL, United States
gladys.martin@romark.com
Gloria Ferko
Consultant, Quality & Regulatory
Gloria Ferko, QA/RA Consultant
Palmerton, PA, United States
gmferko@ptd.net
Golnaz Moeini
Sr. Regulatory Affairs Analyst
Stryker
San Jose, CA, United States
golnaz.moeini@gmail.com
Gopal Patel
Regulatory Affairs Specialist
Navinta LLC
Ewing, NJ, United States
gopal.patel@navinta.com
Gopinath. N Nallusamy
Scientist
Par Formulations Pvt Ltd
Chennai, Non-US, India
gopz07@gmail.com
Gordon Willins
Quality Manager
EPIC Technologies
Mason, OH, United States
gordon.willins@epictech.com
Grace Suh
Regulatory Specialist
Passy-Muir
Irvine, CA, United States
gsuh84@gmail.com
Graciela Salazar Vargas
Specialist
Goverment
San Jose, Non-US, Costa Rica
gsalazar@ministeriodesalud.go.cr
Greg Burkholder
CEO
Transitions Industries
Lubbock, TX, United States
greg.burkholder@tlcunit.com
Greg Freeman
Senior Engineer
Good Automation, LLC
Irving, TX, United States
jenngray3904@yahoo.com
Greg Freeman
Senior Engineer
Good Automation, LLC
Irving, TX, United States
Greg.freeman@goodautomation.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Greg Moreau
QA/RA
Centrix, Inc.
Shelton, CT, United States
gmoreau@centrixdental.com
Gregg Ritter
Regulatory Affairs Specialist
Acumed
Hillsboro, OR, United States
gregg.ritter@gmail.com
Gregor Dzialas
Director Regulatory Affairs
NxStage Medical, Inc.
Lawrence, MA, United States
gdzialas@nxstage.com
Gregory Happe
Quality Assurance Specialst I
Maine Standards Company
Cumberland Foreside, ME, United States
ghappe@mainestandards.com
Guangyu Luo
Senior RA Associate
Prinston Pharmaceutical Inc.
Cranbury, NJ, United States
guangyu.luo@prinstonpharm.com
Hana Boudiaf
Regulatory affairs specialist
Medincell
Jacou, Non-US, France
hana.boudiaf@medincell.eu
Hannah Le
Student
Purdue
West lafayette, IN, United States
hannahlepharmd@gmail.com
Hannah Rafols
Document Coordinator
Chiesi USA, Inc.
Cary, NC, United States
hannah.rafols@chiesi.com
Hanne Nielsen
Regulatory Affairs Manager
3shape A/S
Copenhagen, Non-US, Denmark
hanne.nielsen@3shape.com
Hardik Gohil
Intern
Aavis pharmacuticals
Atlanta, GA, United States
hgohil09@gmail.com
Harel Halevi
CEO
Nefield Diagnostics
Tel Aviv, Non-US, Israel
harel@nefield.com
Harendra Chauhan
Regulatory Project Manager
Sun Pharmaceutical
Gurgaon, Non-US, India
harendra.singh@sunpharma.com
Harikishan Komma
Head-Regulatory Affairs
Caplin Point Laboratories Limited
Chennai, Non-US, India
harikomma@gmail.com
Harikishan Komma
Head - Regulatory Affairs
Caplin Point Laboratories Limited
Chennai, Non-US, India
harikishan@caplinpoint.net
Harlow Thielke
Regulatory Affairs Coordinator
Starkey Hearing Technologies
Eden Prairie, MN, United States
harlow_thielke@starkey.com
Harriet Kamendi
Director
Kandih Group
Silver Spring, MD, United States
harriet_kamendi@kandih.com
Hasmukh Patel
Acting Director
FDA
Silver Spring, MD, United States
hasmukh.patel@fda.hhs.gov
Hasnat Dastgir
Production Manager
Standpharm Pakistan (Pvt.) Ltd.
Lahore, Non-US, Pakistan
hasnat76@hotmail.com
Heather Bryant
Quality Assurance Specialist II
Maine Standards Company
Cumberland Foreside, ME, United States
hbryant@mainestandards.com
Heather Erdman
CSO
FDA/CBER
Silver Spring, MD, United States
heather.erdman@fda.hhs.gov
Heather Gingerich
Regulatory Affairs Associate
Sun Pharmaceutical Industries, Inc.
Bryan, OH, United States
heather.gingerich@sunpharma.com
Heather Lambert
Regulatory Administrator
Investigative Clinical Research of Indiana,
LLC
Indianapolis, IN, United States
admin@investigativeicr.com
Helen Sun
Associate Director, Regulatory Affairs
Valeant Pharmaceuticals
Bridgewater, NJ, United States
helen.sun@bausch.com
Helen Hu
VP QA
wilmington pharmatech
Newark, DE, United States
helen.hu@wilmingtonpharmatech.com
Helen Lewis
Corporate Regulatory Affairs Director
Dentsply International
York, PA, United States
hlewis@dentsply.com
Helen Zhou
Senior Associate Director
Bristol-Myers Squibb
Princeton, NJ, United States
helen.zhou@bms.com
Henry Eran
Director Quality Control
C3 Jian
Marina del Rey, CA, United States
heran@aol.com
Heran Jang
Qualitay Assurance Manager
Nano-Ditech Corporation
Cranbury, NJ, United States
hrjang@nanoditech.com
Hetal Shah
CEO
Arizona Women's Specialists
phoenix, AZ, United States
hetalcshahmd@yahoo.com
Hilda Grabczewski
Regulatory Specialist
National Cancer Institute
Rockville, MD, United States
hilda.grabczewski@nih.gov
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Himani Gohil
Intern
Pharmaceutics international inc
Hunt valley, MD, United States
himani7994@gmail.com
Himanshu Jain
QA Manager, Product Development
Contract Pharmaceuticals Limlted
Mississauga, Non-US, Canada
hjain@cplltd.com
Hippolitus Odukwu
Director, QA & Regulatory Affairs
Angelini Pharma Inc.
Gaithersburg, MD, United States
hodukwu@angelini-us.com
Hitesh Bhagat
President
AP Medesthetics, Inc.
Wayland, MA, United States
hb@veingogh.com
Holli Vaughan
Regulatory Project Manager
Biologics Consulting Group, Inc.
Alexandria, VA, United States
hvaughan@bcg-usa.com
Hollie Johnson
Quality/Regulatory Manager
Swissray International
Piscataway, NJ, United States
hollie.johnson@swissray.com
Holly Opdyke
Regulatory Compliance Analyst
J. Knipper & Company
Lakewood, NJ, United States
Holly.Opdyke@Knipper.com
Hua Deng
president
davidia healthtech
san diego, CA, United States
info@davidiahealthtech.com
Hui Tang
President
Innervo Technology LLC
Columbia, MO, United States
htang@innervotech.com
Humaira Siddique
Head of Quality Assurance
Highnoon laboratories
Lahore, Non-US, Pakistan
humaira.siddk@gmail.com
Huy Truong
associate director
Johnson & Johnson
raritan, NJ, United States
htruong@its.jnj.com
Iacovos Kyprianou
Senior Science Health Advisor
US FDA
Silver Spring, MD, United States
iacovos.kyprianou@fda.hhs.gov
Ihsan Haddad
President
Anesthesia Safety Products, LLC
Woburn, MA, United States
iahaddad@aspamerica.com
Ilana Fogelman
Chief Operating Officer
LifeTech Research
Washington, DC, United States
ifogelman@lifetechresearch.com
Imtiyaz Ubharay
Manage R&D-QA
Tris Pharma Inc.
Monmouth Junction, NJ, United States
iubharay@trispharma.com
Ipsa Patel
Regulatory Affairs Associate
Aveva Drug Delivery Systems, Inc
Miramar, FL, United States
Ipsa.patel@avevadds.com
Isabel Cisneros
Regulatory Affairs
RGR Pharma Ltd.
LaSalle, Non-US, Canada
Isabel@rgrpharma.com
Isabelle Morin
Compliance Specialist
Delta Pharma inc.
Montréal, Non-US, Canada
isa.morine@hotmail.ca
Israel Citron
VP QA/RA
Aspect Imaging LTD
Shoham, Non-US, Israel
icitron@aspectimaging.com
Ivan Stangel
Scientific Director
BioMat Sciences
Bethesda, MD, United States
stangel@biomatsciences.com
Ivy Bautista
Assoc. Director RA
Ferring Pharmaceuticals Inc
Parsippany, NJ, United States
ivy.bautista@ferring.com
Izumi Clifford
Regulatory and Quality Supervisor
Shimadzu Scientific Instruments
columbia, MD, United States
izclifford@shimadzu.com
Jace Kelley
Engineer
MED Institute, Inc.
West Lafayette, IN, United States
jdkelley@medinst.com
Jack Kent
Director of Regulatory Affairs
Clear Guide Medical
Baltimore, MD, United States
kent@clearguidemedical.com
Jackie Lafollette
VP Regulatory
Chase Medical
Richardson, TX, United States
jlafollette@chasemedical.com
Jaclyn Collins
Quality Assurance Manager
Medical Technologies of Georgia, Inc
Covington, GA, United States
jcollins@medtechga.com
Jacqlyn Riposo
Regulatory Specialist
AABB
Bethesda, MD, United States
jriposo@aabb.org
Jagadeesha V P
Group Head
WIPRO LIMITED
Bangalore, Non-US, India
jagadeesh.vpj@wipro.com
Jaime Casas
International Sales Director
American Non-stop Label
Los Angeles, CA, United States
jaimec@anslabels.com
Jaime Lee
Regulatory Affairs Associate
Terumo Cardiovascular Systems
Elkton, MD, United States
jaime.lee@terumomedical.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
James Bertram
CDRH Jurisdictional Officer
FDA
silver spring, MD, United States
james.bertram@fda.hhs.gov
James Champlin
Manager, Qa & RA
Maine Standards Company
Cumberland Foreside, ME, United States
jchamplin@mainestandards.com
James Gill
Quality Manager
Gorbel Medical
Fishers, NY, United States
jamgil@gorbel.com
James Juul
Vice President
Curatek Pharmaceuticals LLC
Elk Grove Village, IL, United States
jjuul@curatek.com
James Mayol
Director, QA & Regulatory Compliance
Augmenix, Inc.
Waltham, MA, United States
jmayol@augmenix.com
James Rogers
President
Coastal Consulting Group
Pittsburgh, PA, United States
scripts@coastalcg.com
James Vogan
Quality Systems Auditor
Fresenius Medical Care
Waltham, MA, United States
james.vogan@fmc-na.com
Jami Miller
Regulatory Director
Medallion Therapeutics
Santa Clarita, CA, United States
jami.miller@medalliontx.com
Jamie Brugnano
Research Scientist
Organovo
San Diego, CA, United States
jbrugnano@organovo.com
Jan Miller
Research Coordinator, RN
Gwinnett Medical Center
Lawrenceville, GA, United States
jmiller16@gwinnettmedicalcenter.org
Jan Triani
QA/RA
EDGE Orthopaedics
Boonton, NJ, United States
jantriani@gmail.com
Jane Cook
Regulatory Affairs Scientist
USAMMDA
Frederick, MD, United States
jane.m.cook4.civ@mail.mil
Jane Stachura
VP, Regulatory Affairs, CMC
Marathon Pharmaceuticals, LLC
Northbrook, IL, United States
jstachura@marathonpharma.com
Janet Bukovcan
Senior Manager, Regulatory Affairs
BTG
Ottawa, Non-US, Canada
janet.bukovcan@btgplc.com
Jared Mcdonley
Compliance Manager
OneBlood
Fort Lauderdale, FL, United States
jared.mcdonley@oneblood.org
Jason Hartnett
QA/RA Mgr.
Lab Crafters, Inc.
Ronkonkoma, NY, United States
jhartnett@lab-crafters.com
Javeriya Ansari
Business Development Executive
Pharma
Karachi, Non-US, Pakistan
jerryjemini@gmail.com
Javorka Gunic
QA Manager
Evofem
San Diego, CA, United States
jgunic@evofem.com
Jay Trivedi
Director
Patrin Pharma
Skokie, IL, United States
jay.trivedi@patrinpharma.com
Jaya Dhiman
Sr. Executive CQA
Sentiss Pharma
Gurgaon, IN, India
jdhiman@sentisspharma.com
Jayesh Rajgopal
Resident
GANDHI MEDICAL COLLEGE, BHOPAL
BHOPAL, Non-US, India
jayeshshenoy@gmail.com
Jean Pak
Director, Regulatory and Clinical Affairs
OPHTEC USA, Inc.
Boca Raton, FL, United States
jean.pak@usa.ophtec.com
Jeannine Ramsey
Consultant
Accurate Clinical Solutions
Wellington, OH, United States
Jeannine_Ramsey@icloud.com
Jeevan Kumar Kunuku
Sr. Officer
Gland Pharma Limited
Hyderabad, Non-US, India
jeevan.k09@gmail.com
Jeff Cline
Prin SQE
R&Q Solutions
Jacksonville, OH, United States
jaxcline5@bellsouth.net
Jeff Cline
SQE
R&Q Solution
Cleveland, OH, United States
jeff.cline@philips.com
Jeff Yao
Regulatory Affairs Manager
Sunny Pharmtech Inc.
New Taipei City, Non-US, Taiwan
jeff.yao@sunnypharmtech.com
Jeffrey Cooper
Supervisory Health Scientist
FDA
Silver Spring, MD, United States
jeffrey.cooper@fda.hhs.gov
Jeffrey Hausfeld Md, Mba
Chairman of the Board
BioFactura
Frederick, MD, United States
jhausfeld@sopenet.org
Jenee Bevett
Reg Affairs Specialist/Technical Coord.
Social & Scientific Systems, Inc.
Silver Spring, MD, United States
JBevett@S-3.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Jeness Jose
Regulatory Affairs
Sandoz Inc.
Princeton, NJ, United States
jeness.jose@sandoz.com
Jeness Jose
Regulatory Affairs
Sandoz
Trenton, NJ, United States
jeness.alex@gmail.com
Jennifer Innamorato
Quality Engineer
Perryman
Houston, PA, United States
jinnamorato@perrymanco.com
Jennifer Sunshine
Lead Associate
Booz Allen Hamilton
Washington, DC, United States
sunshine_jennifer@bah.com
Jennifer Timmerman
Director of Regulatory Affairs
Kedrion Biopharma
Fort Lee, NJ, United States
jennifertimmerman2@gmail.com
Jenny Li
Staff Scientist
Noramco
Wilmington, DE, United States
jli110@its.jnj.com
Jenny Zhang
Chief Scientist
Andersen Sterilizers
Haw River, NC, United States
jennyzhang@andersensterilizers.com
Jenny Zong
Regulatory Specialist
Reach Surgical,Inc
Tianjin, Non-US, China
jennyzong1986@yahoo.com
Jeremy Richardson
Complaint Coordinator
Telcare Medical Supply
Concord, MA, United States
jrichardson@telcaresupport.com
Jessica Clemmons
Quality Engineer
YSI, Inc.
Yellow Springs, OH, United States
clemmons.jess@ysi.com
Jessica Heckrote
Sr. Quality Technician
Oakworks
New Freedom, PA, United States
jheckrote@oakworks.com
Jessica Kelley
Product Manager
EMC
Princeton, NJ, United States
jessica.kelley@emc.com
Jessica Kokosinski
Assistant Vice President
Genpact Pharmalink
Baltimore, MD, United States
jessica.kokosinski@genpact.com
Jessica Montejo
Sr. RA Specialist
Medline
Mundelein, IL, United States
jessicarivera143@hotmail.com
Jessica Ralyn
Senior Manager, Quality
Exact Sciences
Madison, WI, United States
jralyn@exactsciences.com
Jessica Swanson
Senior Regulatory Affairs Specialist
LifeCell Corporation
Bridgewater, NJ, United States
jessica.swanson@acelity.com
Jibran Khan
Assistant Manager Regulatory Affairs
SEARLE
Karachi, SC, Pakistan
jibranrajput74@gmail.com
Jihyeon Kim
Project Assistant
KCRN Research
Germantown, MD, United States
jhkim@kcrnresearch.com
Jingran Lu
RA Speclist
Prinston Pharmacutical Inc.
cranbury, NJ, United States
jingran.lu@prinstonpharm.com
Jinous Saeedi
Manager Compliance Quality System
IRVINE SCIENTIFIC
Irvine, CA, United States
jsaeedi@irvinesci.com
Jismi Johnson
Regulatory Advisor
FDA/CDRH
Silver Spring, MD, United States
jismi.johnson@fda.hhs.gov
Jo Collins
Manager, Quality Clinical Compliance
Ora, Inc.
Andover, MA, United States
jcollins@oraclinica.com
Joan Cheng
QA & RA Manager
NovoDiax
Hayward, CA, United States
Joancheng@novodiax.com
Joan Cheng
Director
GQM
Oakland, CA, United States
Joanskcheng@hotmail.com
Joan Fanis
QA Manager Sterile Forms
Rafarm S.A.
Athens, Non-US, Greece
i.papatheofani@rafarm.gr
Joan Tomczyk
QA/RA Assistant Manager
Hiossen Inc
Fairless Hills, PA, United States
tomczyk.j@hiossen.com
Joann Brumbaugh
Nurse Consultant
FDA
Silver Spring, MD, United States
joann.brumbaugh@fda.hhs.gov
Joann Pittman
Public Affairs Specialist
Food and Drug Administration
Atlanta, GA, United States
JoAnn.Pittman@fda.hhs.gov
Joanne Marriott
SVP
Amerigen Pharmaceuticals Inc
Lyndhurst, NJ, United States
jmarriott@amerigenpharma.com
Joe Murphy
Director, Combination Products Compliance
Janssen
Neuchatel, Non-US, Switzerland
jmurph28@its.jnj.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
John Bielski
Quality Assurance Manager
M&C Specialties
Southampton, PA, United States
jbielski@mcspecialties.com
John Gill
Clinical Manager
St. Jude Medical
Sylmar, CA, United States
jgill@sjm.com
John Gorney
Quality Manager
Signal Medical Corporation
Marysville, MI, United States
jgorney@signalmd.com
John Huang
Consumer Safety Officer
FDA
Silver Spring, MD, United States
john.huang@fda.hhs.gov
John Huff
Director, Risk Management
AtriCure Inc.
West Chester, OH, United States
jhuff@atricure.com
John Maddalena
Quality Director
Haemtech Biopharma Services
Essex Junction, VT, United States
jmaddalena@haemtech.net
John Mundi
Product Information Officer
Health Canada
Ottawa, Non-US, Canada
john.mundi@hc-sc.gc.ca
John Oberholtzer
Senior Regulatory Affairs Manager
Celerity Pharmaceuticals, LLC
Rosemont, IL, United States
joberholtzer@celeritypharma.com
John Ruiz
Staff Fellow
FDA-CDRH
White Oak, MD, United States
john.ruiz@fda.hhs.gov
John Zehner
Executive Vice President and COO
Global Isotopes/Zevacor Molecular
Noblesville, IN, United States
wcomer@zevacor.com
Jonas Kazmirczak
Analyst
Prati Donaduzzzi
Toledo, Non-US, Brazil
jonaskzk@gmail.com
Jonghyeon Kim
Sr Manager Biostatistics
Otsuka
Rockville, MD, United States
jonghyeon.kim@otsuka-us.com
Jorge Castanos
President
Quality and Regulatory Compliance Corp.
Gurnee, IL, United States
qrccorporation@gmail.com
Jose Centeno
Division Director, DBCMS
U.S. FDA - CDRH - OSEL
Silver Spring, MD, United States
jose.centeno@fda.hhs.gov
Joseph Hillring
Regulatory Affairs Associate
Hillring & Associates Inc.
Tampa, FL, United States
Joseph.Hillring@gmail.com
Joseph Tartal
Branch Chief
Food and Drug Administration
Silver Spring, MD, United States
joseph.tartal@fda.hhs.gov
Joy Frestedt
President and CEO
Frestedt Inc.
Saint Louis Park, MN, United States
jf@frestedt.com
Joyce Dean
Regulatory Compliance Manager
Universal Medical, Inc.
Ewing, NJ, United States
jdean@mednethealth.net
Juan Zong
Regulatory Affairs Executive
Reach Surgical, Inc
Tianjin, Non-US, China
zongjuan@chinasurg.com
Judith Cohen
Director QA
Particle Sciences Inc
Bethlehem, PA, United States
jcohen@particlesciences.com
Judy Costello
Acting Executive Director
BioMaryland
Baltimore, MD, United States
judith.costello@maryland.gov
Judy Snow
VP, QA/RA
Keller Medical
Stuart, FL, United States
judy@kellerfunnel.com
Julia Choi
Quality Engineer - Risk Management
Intuitive Surgical
Sunnyvale, CA, United States
julia.choi@intusurg.com
Julia Lynne
Project Manager
The Emmes Corporation
Rockville, MD, United States
jlynne@emmes.com
Julie Anne Zawisza
Associate Director for External Relations
FDA
Silver Spring, MD, United States
julie.zawisza@fda.hhs.gov
Julie Koch
Interim Director of Cancer Research
MacNeal Hospital
Berwyn, IL, United States
jkoch@vhschicago.com
Julienne Pearson
Associate
Teva Pharmaceuticals
Woodcliff Lake, NJ, United States
julienne.pearson@tevapharm.com
Julieta Catania
Quality Manager
TECME
Córdoba, AR, Argentina
julieta.catania@tecme.com.ar
Julio Lin
assistant Vice President
Fish
Taipei, Non-US, Taiwan
julio168@gmail.com
Julio Rivera
Directo of Compliance Initiatives
Regulatory and Quality Solutions LLC
Pittsburgh, PA, United States
jrivera@rqteam.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Junaid Rehan Syed
Visiting Faculty
Aklima CRO
Karachi, Non-US, Pakistan
sjr.fst@gmail.com
Junle Ren
Senior Researcher
Yiling Pharmaceutical Ltd
Shijiazhuang, Non-US, China
maysoler@qq.com
Justin Metcalf
Engineering manager
Med institute
West Lafayette, IN, United States
Jmetcalf@medinst.com
Justin Uthup
Manager, Regulatory Affairs
ANI Pharmaceuticals, Inc.
Baudette, MN, United States
justin.uthup@anipharmaceuticals.com
Kalyani Tammareddy
QUALITY SYSTEMS MANAGER
JOHNS HOPKINS UNIVERSITY
BALTIMORE, MD, United States
ktammar1@jhmi.edu
Kamal Negi
Corporate Quality Assurance
Sentiss
Faridabad, Non-US, India
knegi@sentisspharma.com
Kamarthi Murali
Deputy Manager
Biocon
Bangalore, IN, India
murali.kamarthi@biocon.com
Kandarp Shah
Regulatory Affairs Administrator
STAAR Surgical Company
Monrovia, CA, United States
ShahKandarpH@gmail.com
Kapil Dev
Manager - Regulatory Affairs
Titenare GXL
Bengaluru, Non-US, India
kapil@titenaregxl.com
Karen D. Orr
CEO, Founder
OhZ, LLC
Madison, WI, United States
kdorr35@hotmail.com
Karen Denny
Regulatory Affairs Specialist
Becton Dickinson Diagnostics
Durham, NC, United States
karen_denny@bd.com
Karen Houseton
QA/RA Consultant
MAK and Associates
Dousman, WI, United States
karen@makcompliance.com
Karen Kim
Regulatory Manager
Stocosil Inc.
City of Industry, CA, United States
kkim@autotelicinc.com
Karen Metcalfe
Director, Rgulatory Affairs
DVC
Frederick, MD, United States
kmetcalfe@csc.com
Karen Otoole
Manager, Global Regulatory Affairs
Rapid Pathogen Screening Inc
Sarasota, FL, United States
otoole@rpsdetectors.com
Karen Smith
Dir of Reg Compliance
BD
Franklin Lakes, NJ, United States
karenysmith@yahoo.com
Karen Veltri
Oncology Drug Reviewer
Health Canada
Ottawa, Non-US, Canada
karen.veltri@rogers.com
Karen Zimm
Associate Director
J&J
Titusville, NJ, United States
kzimm1@its.jnj.com
Karl Muehlheuser
Associate
Contubernium Worldwide, Inc.
Washington, DC, United States
karl.muehlheuser@yahoo.com
Karl Scott
Sr. Manager, Compliance
Johnson & Johnson
Raritan, NJ, United States
kscott25@its.jnj.com
Karl Zhou
medical director
Kintor
Bridgewater, NJ, United States
karl.zhou@inventivhealth.com
Kartick Das
Manager, Audit & Assurance
GSK Bangladesh Ltd
Chittagong, Non-US, Bangladesh
kartick.c.das@gsk.com
Kassa Ayalew
Branch Chief
FDA/CDER/OSI
Silver Spring, MD, United States
Kassa.Ayalew@fda.hhs.gov
Katarzyna Mielniczuk
Regulatory Affairs
R4M
Jarosław, Non-US, Poland
katarzyna.mielniczuk@gmail.com
Katharina Kurpanek
Managing Director
The QM Company
Brussels, Non-US, Belgium
kurpanek@theqmcompany.com
Katarina Ilic
Executive Director, Global
Pharmacovigiulance and Drug Safety
Raptor Pharmaceuticals
NOVATO, CA, United States
kilic@raptorpharma.com
Katherine Groff
Research Associate
PETA International Science Consortium
Norfolk, VA, United States
KatherineG@piscltd.org.uk
Katherine Timashpolsky
Clinical Research Associate
St. Jude Medical, Inc.
Sylmar, CA, United States
ktimashpolsky@sjm.com
Kathleen Hewitt
Project Manager
Biologics Consulting Group
Alexandria, VA, United States
khewitt@bcg-usa.com
Kathryn Widman
Sr. Consultant
Booz Allen Hamilton
Arlington, VA, United States
widman_kathryn@bah.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Kathy Ababio
IRB Coordinator
Inova Fairfax Medical Campus
Falls Church, VA, United States
researched@inova.org
Kathy Mancl
CCRP
Marshfield Clinic
Marshfield, WI, United States
mancl.kathleen@mcrf.mfldclin.edu
Katie Jackson
Manager
Avalere Health
Washington, DC, United States
kjackson@avalere.com
Kavonna Allen
Regulatory Affairs Associate I
Facet Technologies, LLC
Atlanta, GA, United States
kavonna_allen@facettechnologies.com
Kazuyuki Atarashi
Global Program Manager
MBL International
Woburn, MA, United States
kazuyuki.atarashi@mblintl.com
Kelley Boyer
Manager, Regulatory Operations
SciLucent
Herndon, VA, United States
k.boyer@scilucent.com
Kellie Kennon
Sr. Director Clinical Research
Asklepion Pharmaceuticals, LLC
Baltimore, MD, United States
kellie.kennon@asklepionpharm.com
Kelly Evers
Sr QA Specialist
ISTO Technologies, Inc.
St. Louis, MO, United States
kevers@istotech.com
Kelly Holmes-Smith
Engineer
DOD
Washington, DC, United States
klholmessmith@gmail.com
Kelly Key
Quality Operations Manager
Endo Pharmaceuticals
Huntsville, AL, United States
kkey@qualitestrx.com
Kelly Reich
Regulatory Project Manager
Biologics Consulting Group, Inc.
Alexandria, VA, United States
kreich@bcg-usa.com
Kelly Scuderi
Regulatory Technical Specialist
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA, United States
kelly.scuderi@siemens.com
Kelly Wilkicki
Senior Advisor
FDA
Silver Spring, MD, United States
kelly.wilkicki@fda.hhs.gov
Kelsey Lawfer
Visiting Scientist Fellow
Eli Lilly and Company
Indianapolis, IN, United States
kelsey.lawfer@lilly.com
Ken Myers
Dir. Global Product Regulatory Affairs
Nu Skin Enterprises
Provo, UT, United States
kmyers@nuskin.com
Kenneth Jablonicky
QA/Reg Director
Graphic Controls
Buffalo, NY, United States
kjablonicky@graphiccontrols.com
Kenny Struwig
MARCOM Manager
Sion Biotex Medical Ltd.
Hagoshrim, Non-US, Israel
kenny@sn-medical.com
Kerry Armstrong
Director, Compliance
Picis Clinical Solutions, Inc.
Wakefield, MA, United States
Kerry_Armstrong@optum.com
Kervain Cao
QA
DANYANG JUMAO
DANYANG, Non-US, China
476583883@qq.com
Kevin Daly
Principal
Kevin Daly Consulting, LLC
Encinitas, CA, United States
kevinedaly@gmail.com
Kevin Murrock
Principal Consultant
QR Medical Consulting
Twinsburg, OH, United States
kevin.murrock@qrmedicalconsulting.com
Kevin Norman
Principle Owner
NKI BIOPHARMACEUTICALS, LLC
King of Prussia, PA, United States
nki_pharm@m.com
Kevin Olcott
Director of Technical Operations
Anutra Medical
Morrisville, NC, United States
kevin@anutramedical.com
Khalil Dahdouh
International Director
Medi Express Inc
Garfield, NJ, United States
khalildahdouh@yahoo.com
Khaudeja Bano
Sr. Med Dir / Head of Medical device
Safety
AbbVie Inc
Chicago, IL, United States
khaudeja.bano@abbvie.com
Ki Kim
Project Assistant
KCRN Research
Boyds, MD, United States
kkim@kcrnresearch.com
Khemraj Hirani
Director, Regulatory Affairs and QA
University of Miami Miller School of
Medicine
Miami, FL, United States
Khirani@med.miami.edu
Kim Life
Attorney
Life Law
Lakeside, CA, United States
klife@klifelaw.com
Khurram Khan
RA Manager
Blu Pharmaceuticals
Franklin, KY, United States
kkhan@blurx.us
Kim Schiltz
Study Coordinator
University of Iowa Hospitals & Clinics
Iowa City, IA, United States
kimberly-schiltz@uiowa.edu
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Kim Van Horn
Research Coordinator
Investigative Clinical Research of IN, LLC
Indianapolis, IN, United States
kvanhorn@investigativeicr.com
Kimberly Grevera
Regukatory Affairs Manager
GeNO LLC
Cocoa, FL, United States
kimberly.grevera@genollc.com
Kimberly Light
Director of Regulatory Affairs
BioPro
Port Huron, MI, United States
klight@bioproimplants.com
Kimberly Patterson
Assoc. Director
WES Pharma Inc.
Westmister, MD, United States
kpatterson@wespharma.com
Kimberly Piermatteo
Engineer
FDA/CDRH
Silver Spring, MD, United States
kimberly.piermatteo@fda.hhs.gov
Kiran Singh
Associate Director
Sandoz Inc.
Princeton, NJ, United States
kiran.singh@Sandoz.com
Kishore Addanki
Assistant Manager
Mylan Laboratories Limited
Hyderabad, Non-US, India
kishore.addanki@mylan.in
Komila Fayzieva
Assistant Administrator
Pharmaceutics International Inc
Hunt Valley, MD, United States
kama8866@gmail.com
Kory Hallett
Health Science Policy Analyst
National Cancer Institute
Bethesda, MD, United States
kory.hallett@nih.gov
Krasi Pekova
Pharmacist
Northeastern University
Boston, MA, United States
pekova.k@husky.neu.edu
Kris Faria
Sr Mgr Regulatory Ops/RA Assoc
KaloBios
South San Francisco, CA, United States
kfaria@kalobios.com
Kristin Benokraitis
Director of Quality and Operations
EG-GILERO
Durham, NC, United States
kristinb@eg-gilero.com
Kristin Henney
Associate Director
Baxter Healthcare
Round Lake, IL, United States
kristin_henney@baxter.com
Krupal Rewanwar
Sr. RA Specialist
ORS
Itasca, IL, United States
krewanwar@organ-recovery.com
Kyu-Pyo Kim
Assistant Professor
Asan Medical Center
Seoul, Non-US, South Korea
kkp1122@amc.seoul.kr
L Meghana Pamidighantam
Quality Assurance Manager
AnshLabs
Webster, TX, United States
mpamidighantam@anshlabs.com
Lacey Holman
Regulatory Affairs Project Manager
Mallinckrodt Pharmaceuticals
Hazelwood, MO, United States
lacey.holman@mallinckrodt.com
Lakeshia Stitt
Sr. Compliance Specialist
Pharmaceutical Associates, Inc
greenville, SC, United States
lstitt@paipharma.com
Lakshmi Kodeboyina
Consultant
Invigo soft
Irving, TX, United States
sirikodeboyina@gmail.com
Larissa Mitchell
Research Compliance Coordinator
Upstate Cardiology
Greenville, SC, United States
lmitchell@upstatecardiology.com
Lars Lafferty
Sales Consultant
Private
Syosset, NY, United States
lars@nmdhealthcare.com
La-Shaunda Joseph
Regulatory Affairs
Rochem International, Inc.
Hauppauge, NY, United States
lsjoseph@rochemintl.com
Laura Boll
Vice President Quality and Regulatory
Affairs
Medovations
Medovations, WI, United States
lboll@medovations.com
Laura Semler
President
CSV Solutions Inc
Cincinnati, OH, United States
ldsemler@yahoo.com
Laura Cannon
Researach Coordinator
Medacta USA
Eustis, FL, United States
sktalisman1@aol.com
Lauren Kamer
Senior Regulatory Affairs Specialist
Biomet 3i LLC
Palm Beach Gardens, FL, United States
lauren.kamer@zimmerbiomet.com
Lauren Nicholes
Regulatory Compliance Specialist
DePuy Synthes
West Chester, PA, United States
lnichole@its.jnj.com
Laura Eder
Manager, Regulatory Affairs
TOLMAR Inc.
Fort Collins, CO, United States
leder@tolmar.com
Laurel Clark
Associate Regulatory Affairs Project
Manager
Perrigo Company
Allegan, MI, United States
laurel.clark@perrigo.com
Laurel Berzanskis
Regulatory Affairs Officer
Materialise
Leuven, Non-US, Belgium
laurel.berzanskis@materialise.be
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Lauren Ratzel
Director, Medical Device Quality
Blue Spark Technologies
Westlake, OH, United States
lratzel@bluesparktechnologies.com
Laurie Lenkel
Ombudsman
FDA
Silver Spring, MD, United States
Laurie.Lenkel@FDA.HHS.gov
Lawrence Emere
QA ASSOCIATE
PREPHARM
TRENTON, NJ, United States
okeyemere@yahoo.com
Leanna Lomax
Program Analyst
Food and Drug Administration
Silver Spring, MD, United States
Leanna.Lomax@fda.hhs.gov
Leanne Sleer
Senior Medical Writer
INC Research
Washington, DC, United States
lsleer@hotmail.com
Lee Clermont
Director of Quality
Global Interconnect
Pocasset, MA, United States
lclermont@globalinterconnect.com
Lei Li
VP, Clinical and Regulatory Affairs
Veritas Genetics Inc
Danvers, MA, United States
lei.li@veritasgenetics.com
Lei Li
Clinical and Regulatory Affairs
Veritas Genetics
Danvers, MA, United States
lei.li@veritasgene.com
Lena Shafir
Regulatory Product Manager
EMC
Feasterville, PA, United States
yelena.shafir@emc.com
Leona Saunders
Associate Director of RA and QA
Curis
Lexington, MA, United States
lsaunders@curis.com
Liat Talias
Regulatory Affairs and QA Project Manager
MedialCS
Kfar Malal, Non-US, Israel
Liat@medialcs.com
Lilach Weisblat-Hershkovich
CEO
Quapedia
Israel, Non-US, Israel
slweisblat@aol.com
Lili Jiang
Regulatory Affair Manager
Guangzhou Henovcom Bioscience Co., Ltd.
Guangzhou, Non-US, China
lilijiang@henovcom.com
Lily Goldstein
QA/RA Director
BeamMed Ltd
Petah Tikva, Non-US, Israel
lily@beammed.com
Linna Wei
Principal Associate, RA-CMC
Genzym A Sanofi Company
Westborough, MA, United States
linna.wei@genzyme.com
Lisa Ballanco
Senior Business Anaylst
CSC
Norristown, PA, United States
lballanco@csc.com
Linda Grasfeder
Senior Clinical Pharmacologist and
Pharmacokineticist
Nuventra
Durham, NC, United States
llgrasfeder@gmail.com
Lisa Crockett
Vice President, Regulatory Affairs
InVivo Therapeutics
Cambridge, MA, United States
lcrockett@invivotherapeutics.com
Lisa Gallatin
Director of Regulatory
Vascular Solutions
Maple Grove, MN, United States
lgallatin@vasc.com
Lisa Pritchard
Senior Director of Regulatory Affairs
EnteroMedics, Inc.
Saint Paul, MN, United States
lpritchard@enteromedics.com
Lisa Wegman
Quality Engineer
self-employed
Reading, PA, United States
lisawegman@gmail.com
Lixia Wang
Medical Research Scientist
FDA China Office
Beijing, Non-US, China
wanglx@state.gov
London Toney
Scientific Project Analyst
NIH
Rockville, MD, United States
london.toney@nih.gov
Loretta Chi
Sr. Regulatory Policy Analyst
FDA
Silver Spring, MD, United States
loretta.chi@fda.hhs.gov
Lori Rolfe
QA Officer
Microbac Laboratories Inc., WNC
WIlson, NC, United States
lori.rolfe@microbac.com
Lorie Laird
Regulatory Affairs Manager
Scanadu
Mountain View, CA, United States
lorie.laird@gmail.com
Lucrezia Hinman
Director, Regulatory Affairs
County Line Pharmaceuticals
Brookfield, WI, United States
lhinman@countylinepharma.com
Luis Lopes
QA & RA Manager
Lopes Business Solutions
Fort Myers, FL, United States
gustavopes@hotmail.com
Lucile Marron
QA/RA expert
Surigiqual institute
grenoble, Non-US, France
lucile.marronbrignone@surgiqualinstitute.com
Luis Velásquez
Licenciado en Biología
LMB H.COLICHON S.A.C
lima, ME, Peru
luisrayvc@hotmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Luisa Earney
Director of Quality Assurance
Lenkbar LLC
Naples, FL, United States
learney@lenkbar.com
Luz Escolar
Regulatory Affairs
OMT LLC
Fort Lauderdale, FL, United States
admin@traatek.com
Luz Villamizar
Principal RA Specialist
Immucor
Warren, NJ, United States
lvillamizar@immucor.com
Lynn Berkowitz
Principal Consultant
EMC
Evergreen, CO, United States
lynn.berkowitz@emc.com
Lynn Wilson
Clinical and Regulatory Project Manager
Ximedica, LLC
Providence, RI, United States
lwilson@ximedica.com
Lynne Housand
Scientist
AEgis Technologies Group
Orlando, FL, United States
lhousand@admewb.com
Lynne Witkowski
Manager Regulatory Affairs
Medela
McHenry, IL, United States
lynne.witkowski@medela.com
Lyudmila Kipnis
RA consultant
Independent
Seattle, WA, United States
milakipnis@hotmail.com
Maayan Elias
BDO
Pepticom
jerusalem, Non-US, Israel
maayan.elias@pepticom.com
Madelein English
Consultant
Self employed consultant
Cape Town, Non-US, South Africa
Madelein.english@gmail.com
Madhu Malo
President & CEO
Atoxin Biotech, LLC
Worcester, MA, United States
madhumalo@hotmail.com
Madhuri Jerfy
Senior Scientist
Boehringer Ingelheim
Ridgefield, CT, United States
madhuri.jerfy@gmail.com
Madhusoodana Nambiar
Policy Advisor
FDA/CDRH
Silver Spring, MD, United States
Madhusoodana.nambiar@fda.hhs.gov
Madhvi Upender
CEO
Awarables, Inc.
Potomac, MD, United States
madhvi@awarables.com
Maged Batis
Sr. R&D Pharmacist
Riyadh Pharma
RIYADH, Non-US, Saudi Arabia
majesbatis@gmail.com
Mahesha Rajapakse
Manager, Quality Assurance and
Regulatory Compliance
ReliefBand Technologies
Chicago, IL, United States
mahesha.rajapakse@reliefband.com
Maitri Sanghavi
Scientist
Dr reddys
Hyderabad, Non-US, India
maitrisharadkumar@drreddys.com
Mahmoud Ghannam
Project leader
Hikma Pharmaceuticals
Amman, Non-US, Jordan
mghannam@hikma.com
Mairlyn Waxberg
Senior Princple & Business Expansion
Regulatory and Quality Solutions
Monoevill, PA, United States
mwaxberg@RQTeam.com
Majid Hasheminejad
President/Owner
4-1-1 CONSULTING SERVICES, LLC
York, PA, United States
majid@411consultingservices.com
Maliha Ilias
Product Development Specialist
NIAID
Bethesda, MD, United States
maliha.ilias@nih.gov
Mallik Metukuri
Medical Affairs Scientist
INC Research
Raleigh, NC, United States
mkreddy77@gmail.com
Mana Shirazi-Kia
Quality system manager
LGT medical
Vancouver, Non-US, Canada
mana.shirazikia@gmail.com
Manan Hathi
Staff Regulatory Affairs Specialist
Stryker
Flower Mound, TX, United States
manan.hathi@stryker.com
Manan Patel
Research Officer - Regulatory Affairs
Sun Pharmaceutical Industries Limited
Vadodara, Non-US, India
manan.patel@sunpharma.com
Manikanta K
Regulatory Affairs Executive
Gland Pharma Limited
Hyderabad, Non-US, India
35manikanta@gmail.com
Marc Neubauer
CSO Device Specialist
FDA
Baltimore, MD, United States
marc.neubauer@fda.hhs.gov
Marc Smith
Owner
Elsmar
West Chester, OH, United States
marcsmith102@cinci.rr.com
Marcella Martin
Regulatory Associate II
TOLMAR Inc.
Fort Collins, CO, United States
mmartin@tolmar.com
Marcia Howard
Senior Director, Regulatory & Scientific
Affairs
Consumer Healthcare Products Association
Washington, DC, United States
mhoward@chpa.org
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Marco Theobald
Senoir Regulatory Specialist
Registrar Corp
Hampton, VA, United States
mtheobald@registrarcorp.com
Margaret Mangano
QA/RA Leader
Belmont Instrument Corporation
Billerica, MA, United States
mmangano@belmontinstrument.com
Maria Caturla
Clinical Research
University of Pennsylvania
Philadelphia, PA, United States
caturm@exchange.upenn.edu
Maria Cristina Vaccari
QA Manager
RAND S.r.l.
Medolla, Non-US, Italy
mc.vaccari@rand-biotech.com
Maria Tsyrlin
QA/RA Assistant
BeamMed Ltd
Petah Tikva, Non-US, Israel
mariat@beammed.com
Maribel Rodriguez-Torres
Compliance Specialist
Integra
Anasco, Non-US, Puerto Rico
maribel.rodriguez@integralife.com
Marie Dorat
Regulatory Quality Specialist
BioLegend
San Diego, CA, United States
mdorat@biolegend.com
Marie Christensen
Regulatory Affairs Administrator
Medtronic
Stockholm, Non-US, Sweden
marie.christensen@medtronic.com
Marie-Pierre Fafard
R&D Projects Engineer
Nuvo Research Inc.
Montreal, Non-US, Canada
mfafard@nuvoresearch.com
Marietsy Pujol
Research Analyst
ISCI / University of Miami Miller School
Miami, FL, United States
mpujol@med.miami.edu
Mariusz Szkudlinski
Exec. Vice President & CSO
Trophogen
Rockville, MD, United States
mszkudlinski@trophogen.com
Mark Leuschner
VP Operations
Ionetix Corporation
Newfields, NH, United States
mleuschner@ionetix.com
Mark Pohl
Attorney
Pharma Patent Attorneys, LLC
Morristown, NJ, United States
mark.pohl@LicensingLaw.Net
Mark Schenk
President
Mark F Schenk Consulting
West Lawn, PA, United States
mfschenk@lokconsulting.net
Mark Simmons
Director of QA / RA
J-Pac Medical, LLC
Somersworth, NH, United States
msimmons@j-pacmedical.com
Mark Roessel
VP Regulatory Affairs and Quality
Assurance
Concert Pharmaceuticals
Lexington, MA, United States
mroessel@concertpharma.com
Mark Simmons
Director QA RA
J-Pac Medical
Somersworth, NH, United States
msimmons@j-pac.com
Mark Sistare
Regulatory Affairs Manager
BD
Durham, NC, United States
Mark_Sistare@bd.com
Mark Wita
VP QA/RA
Pharmaceutical Associates, LLC
Tampa, FL, United States
mwita@pa-labs.com
Marlon Jackson
Admin
Shimadzu
Columbia, MD, United States
mwjackson@shimadzu.com
Marsha Meehan
Proposal Manager
MGM Editorial Consulting
Silver Spring, MD, United States
meehan.marsha@gmail.com
Martha Gutierrez
Quality Engineer
Fitopharma
Guadalajara, Non-US, Mexico
marthaleticia.gtz@gmail.com
Marvin Garrett
Vice President RA/Q
Aerie Pharmaceuticals
Irvine, CA, United States
mgarrett@aeriepharma.com
Mary Clark
General Manager
PharmaGenetico
San Antonio, TX, United States
mlopezclark@pharmagenetico.com
Mary Elicone
Associate Director
Sanoif
Bridgewater, NJ, United States
mary.elicone@sanofi.com
Maryalice Worden
Sr. Director Regulatory Affairs
Tetraphase Pharmaceuticals
Watertown, MA, United States
mworden@tphase.com
Maryam Etemad
qualified person
rastagene
hamburg, Non-US, Germany
maryam_remedy@yahoo.com
Maryanne Wong
Nuclear Pharmacist/Quality Assurance
Officer
Hamamatsu/Queen's PET Imaging Center
(cyclotron)
Honolulu, HI, United States
mawong@queens.org
Matan Neeman
Head of Q&R - ICAP
Philips
Haifa, Non-US, Israel
matan.neeman@philips.com
Mark Simmons
Director Quality and Regulatory Affairs
J-Pac Medical
Somersworth, NH, United States
cobblesmash@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Matt Rottinger
Product Integrity Engineer
Evenflo Feeding Inc.
West Chester, OH, United States
matt.rottinger@kcc.com
Matthew Allan
Drug Safety Coordinator
Dohmen Life Science Services
Emeryville, CA, United States
mtallan1013@gmail.com
Matthew Baldwin
Statistician II
TOLMAR Inc
Fort Collins, CO, United States
matt.baldwin@tolmar.com
Maureen Rath
Senior Manager, Regulatory Affairs
Perrigo Company
Minneapolis, MN, United States
Maureen.rath@perrigo.com
Maurice Briggs
Principal
GMB Bio:Pharma Development
Harleysville, PA, United States
gmbriggs@comcast.net
Meena Chettiar
QA/RA Manager
ProMed Pharma
Minneapolis, MN, United States
meenachettiar.mc@gmail.com
Meena Rani
Director, QA & RA
Polygen Pharmaceuticals LLC
Edgewood, NY, United States
meena@polygenpharma.com
Meena Shah
General Manager - Regulatory
Geltec Pvt Ltd
Mumbai, ME, India
meenaashah@gmail.com
Meg Mucha
Director of Global RA
Mortara Instrument, Inc
Milwaukee, WI, United States
meg.mucha@mortara.com
Meghashyam Malashetter
Management Trainee
Sequent Scientific
Mumbai, Non-US, India
mm.meghashyam@gmail.com
Mehwish Saeed
Senior Executive QA Document Control
Scilife Pharma
Karachi, Non-US, Pakistan
mehwish.saeed.siddiqui@gmail.com
Meir Silver
President
Molecular Innovations Technology
Beit Shemesh, Non-US, Israel
msilver137@aol.com
Meira Kain
CEO
pH2O Water Technologies
Kfar Aviv, Non-US, Israel
meira@ph2o.net
Meisam Honarvar Nazari
chief technology officer
Integrated Medical Sensors
Irvine, CA, United States
mhonarvar@gmail.com
Melaney Bouthillette
Sr Scientist
Olivo Labs
Cambridge, MA, United States
mbouthillette@livingproof.com
Melissa Smith
Senior Consultant
MJQuality Solutions, llc
bedford, MA, United States
melsm@hotmail.com
Meriem Gaval Cruz
Regulatory Science Specialist
Cote Orphan
Silver Spring, MD, United States
Meriem@coteorphan.com
Miao Gu
Regulatory Affairs
Yabao Pharmaceutical Group
Beijing, Non-US, China
gumiao@yabaoyaoye.com
Michael Alouane
Director of Quality
American Surgical Company
Salem, MA, United States
michael.alouane@americansurgical.com
Michael Chellson
Principal consultant
Pathways to success consulting
Round Lake, IL, United States
mikechellson@gmail.com
Michael Dawson
Sr. Director of RA/ Deputy General Counsel
Precision Spine, Inc.
Parsippany, NJ, United States
mike.dawson@precisionspineinc.com
Michael Beckelic
Maager, Quality Assurance and Regulatory
Affairs
Sebela Pharmaceuticals Inc.
Roswell, GA, United States
mike.beckelic@sebelapharma.com
Michael El-Shammaa
Supervisory interdisciplinary engineer
FDA
Bethesda, MD, United States
michael.el-shammaa@fda.hhs.gov
Michael Macfarland
Compliance and GMP Manager
ACIC Fine Chemicals, Inc.
Brantford, Non-US, Canada
mmacfarland@acic.com
Michael Morello
Regulatory Consultant
Independent Regulatory Consultant
San Diego, CA, United States
mikemorello23@yahoo.com
Michael Ok
Post-Doc
University of Wuerzburg
Wuerzburg, Non-US, Germany
Michael.Ok@t-online.de
Michael Patz
VP, Clinical and Regulatory
Viatar CTC Solutions
Lowell, MA, United States
michael.patz@viatarctcsolutions.com
Michail Pankratov
Principal
MMP Medical Associates, LLC
Waltham, MA, United States
clregconsult@aol.com
Michele Burtness
Regulatory
Pfizer
New York, NY, United States
michele.burtness@pfizer.com
Michael Freeling
Founder
ScrubSync
Bend, OR, United States
michaelfreeling@mac.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Michele Fusello
Quality Engineer
Animas Corporation
West Chester, PA, United States
mfusello@its.jnj.com
Michelle Maciejewski
QA Manager
Klocke of America Inc.
Ft Myers, FL, United States
michelle.maciejewski@klockeamerica.com
Michelle Mathers
Branch Chief
USAMMDA
Frederick, MD, United States
michelle.w.mathers.civ@mail.mil
Michelle Kliewer
Director
Boehringer Ingelheim
Ridgefield, CT, United States
michelle.kliewer@boehringeringelheim.com
Miguel Angel Carranza Moquillaza
Specialist Evaluator
digemid
Lima, Non-US, Peru
jaqca@hotmail.com
Milisha Bloodworth
Sr. Trade Customs Advisor
FedEx
Memphis, TN, United States
mlbloodworth@fedex.com
Milton Peña
Regulatory Affairs Analyst
MINSA
Lima, Non-US, Peru
miltoncpm@hotmail.com
Ming Anne Kuan
VP Reg
Neovii Biotech
Waltham, MA, United States
anne.kuan@neoviibiotech.com
Mingjie Liu
Scientist
Essenlix
Monmouth Junction, NJ, United States
mingjie.liu@essenlix.com
Minh Luu
Legal nurse consultant
Pepper Hamilton
Princeton, NJ, United States
Mluu19103@yahoo.com
Minjae Shin
Senior Manager
HPI Inc.
Rockville, MD, United States
emptymj@hanall.co.kr
Mira Pekova
Analyst
Artisan
Watertown, MA, United States
Mira.pekova@gmail.com
Miranda Raggio
Sr. Regulatory Program Manager
FDA-CDER-OND
Silver Spring, MD, United States
Miranda.raggio@fda.hhs.gov
Miriam Cuenca Nespral
Hormones Regulatory Affairs Head
Laboratorios León Farma S.A.
León, Non-US, Spain
Miriam.Cuenca@chemogroup.net
Mitul Patel
asst manager
sun pharma
vadodara, Non-US, India
mitul.patel@sunpharma.com
Mohamed Abdeldayem
R&D pharmacist
Hikma pharmaceuticals
Cairo, Non-US, Egypt
mohammed.hamdy7@gmail.com
Mohammad Salman
Director Product Development
Hovione
East Windsor, NJ, United States
msalman@Hovione.com
Mohan Ratanchandani
VP Quality System
mdi Consultants, Inc.
Selden, NY, United States
mohan@mdiconsultants.com
Moira Barton-Varty
Sr Director Regulatory Affairs
Stryker Sustainability Solutions
Tempe, AZ, United States
moira.barton@stryker.com
Mona Sharma
Senior Manager
Sentiss Pharma Pvt Ltd
Gurgaon, Non-US, India
monasharma@sentisspharma.com
Monica Frazier
Integrated Product Development Associate
Rho
Chapel Hill, NC, United States
monica_frazier@rhoworld.com
Monique Carter
Regulatory strategist
Pfizer
Collegeville, PA, United States
Monique.Carter@Pfizer.com
Monique Weitz
VP Regulatory Affairs
Virtus Pharmaceuticals
Tampa, FL, United States
mweitz@virtusrx.com
Morgan Michalek
Senior Regulatory Affairs Associate
Sagent Pharmaceuticals
Schaumburg, IL, United States
mmichalek@sagentpharma.com
Mourad Atlas
Mathematical Statistician
FDA/CDRH/OSB/DBS
Silver Spring, MD, United States
mourad.atlas@fda.hhs.gov
Muhammad Saiduzzaman
Director of Quality
Circuit Works Corporation
Waukegan, IL, United States
msaiduzzaman@cwcems.com
Muhammad Sarfaraz
Head of Plant Operations
Cirin Pharmaceuticals (Pvt) Ltd
Islamabad, Non-US, Pakistan
sarfarazpk1@gmail.com
Muhammad Amin Jatoi
Production Lead
Novartis Pharma Pakistan ltd.
Jamshoro, Non-US, Pakistan
aminjatoi@yahoo.com
Muhammad Nazeer Ul Haque
Executive QA
Barrett Hodgson
Karachi, Non-US, Pakistan
nazeer_hq@yahoo.com
Milad Khan
Manager, Global Regulatory Affairs
Janssen R & D
Raritan, NJ, United States
mkhan51@its.jnj.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Muhammad Saquib Qureshi
Dispensing Pharmacist
Adamjee Pharmaceuticals
Karachi, Non-US, Pakistan
drsaquibqureshi@gmail.com
Muhammad Shahid
Asisstan Manager Regulatory Affairs
CKD Pharmaceutical Pakistan (Pvt) Ltd
Karachi, Non-US, Pakistan
muhammad_saad87@outlook.com
Mukesh Sharma
Assistant Manager
Sentiss Pharma
Gurgaon, Non-US, India
msharma@sentisspharma.com
Muna Faidi
Lab supervisor
University of Petra
Kalamazoo, MI, United States
Manarfaidi46@yahoo.com
Munish Mehra
Managing Director
Quantum BioPharma
Gaithersburg, MD, United States
mmehra@qbiop.com
N. Azima
REGULATORY SPEC.
GUMC
WASH, DC, United States
naa3f@gwu.edu
Nadia Harhen
Regulatory Affairs Manager
Qfix
Avondale, PA, United States
nadia.harhen@qfix.com
Nadine Ramos
General Biological Sciences
FDA CDRH OIR
White Oak, MD, United States
nadine.bowdenramos@fda.hhs.gov
Nagaraj Tolnoorkar
QUALITY ASSURANCE
ALLURE LABS
HAYWARD, CA, United States
nagarajbt17@gmail.com
Nagarjuna Bhogadi
REGULATORY AFFAIRS
daewoong pharmaceuticals
HYDERABAD, GA, India
NAGARJUNAA258@GMAIL.COM
Najib Magee
Quality Assurance Specialist
SRI International
Menlo Park, CA, United States
najib.magee@sri.com
Nana Banafo
Manager Clinical Surveillance
CooperSurgical
Trumbull, CT, United States
nana.banafo@copersurgical.com
Nancy Karaszkiewicz
Instructor
GDIT
Frederick, MD, United States
nancy.m.karaszkiewicz.ctr@army.mil
Nancy Mathewson
Director, Regulatory Affairs
PPD
Rockville, MD, United States
Nancy.Mathewson@ppdi.com
Nancy Mckeown
TEST
TEST
TEST, AL, United States
patrick.smith00@gmail.com
Nancy Njuguna
Consultant
Self
Carmel, IN, United States
nancynjuguna@gmail.com
Nancy Pirt
Director, Regulations Staff (CDRH)
FDA
Silver Spring, MD, United States
nancy.pirt@fda.hhs.gov
Narayan Dasuri
Student
Northeastern Univesity
Boston, MA, United States
dasurivenkata.n@husky.neu.edu
Narendira Kumar
Senior Manager
Orchid Healthcare
Chennai, Non-US, India
narendiram@orchidpharma.com
Narendrasinh Gohil
Quality Assurance
Pharmaceutics International Inc.
Hunt Valley, MD, United States
narendrasinhgohil@hotmail.com
Natalia Remmel
Sr. Regulatory Affairs
CD Diagnostics
Claymont, DE, United States
nremmel@cddiagnostics.com
Natalie Elia
Quality Control/Qualitu Assurance
Specialist
Immunostics, Inc.
Ocean, NJ, United States
nelia@immunostics.com
Nathan Anderson
Regulatory Compliance
Janssen
Horsham, PA, United States
NAnders1@its.jnj.com
Natalya Stuherck
Regulatory Affairs -CMC
Daiichi Sankyo
Edison, NJ, United States
nstuherck@dsi.com
Nathalie Innocent
Regulatory Associate
Teva Pharmaceuticals
Norristown, PA, United States
nathalieinnocent@gmail.com
Nathan Johnston
Regulatory Affairs Associate
Ei LLC
Kannapolis, NC, United States
njohnston@eisolutionworks.com
Navneet Sharma
VP of Quality and Regulatory
Daktari Diagnostics, Inc.
HOPKINTON, MA, United States
tsharma@daktaridx.com
Nazish Naz
Sr.Executive
The Searle Company ltd
Karachi, Non-US, Pakistan
nazishnaz@yahoo.com
Neena Saini
Sr. Director, Production
United Therapeutics
Silver Spring, MD, United States
nsaini@unither.com
Neha Taneja
Senior Executive
Sentiss Pharma
Gurgaon, Non-US, India
ntaneja@sentisspharma.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Neha Yadav
Executive
Daewoong Pharmaceutical co.ltd
Hyderabad, IN, India
neha@daewoong.co.kr
Nehru Gaddipati
CEO
Nines Pharma
New York, NY, United States
nehru.gaddjpati@ninespharma.com
Nelson Marquina
R&D Director
USA Laser Biotech Inc.
Richmond, VA, United States
nmarquina@mac.com
Nelson Marquina
Director R&D
USA Laser Biotech
Richmond, VA, United States
nmarquina@usalaser.us
Nelson Quiroga
Profesional assessor
INHRR
Caracas, Non-US, Venezuela
nelson.quiroga@inhrr.gob.ve
Nicholas Tantillo
Head Regulatory Strategy and Policy
Sandoz Inc.
Princeton, NJ, United States
nicholas.tantillo@sandoz.com
Nicole Dove
QA/RA Manager
Summit Medical
St. Paul, MN, United States
ndove@summitmedicalusa.com
Nicole Spaniel
Principal Specialist I
R&Q Solutions, Inc.
Pittsburgh, PA, United States
ncspaniel@gmail.com
Niedre Heckman
Sr. Mgr., Global Regulatory Affairs
Baxalta
Westlake Village, CA, United States
niedre.heckman@baxalta.com
Niki Spaniel
Principal Specialist I
R&Q Solutions
Pittsburgh, PA, United States
nspaniel@rqteam.com
Niki Tsagaratos
Senior Specialist, Regulatory Affairs
Catalent Pharma Solutions
St. Petersburg, FL, United States
niki.tsagaratos@catalent.com
Ninad Gujar
Director, Regulatory and Quality
Neurologica (Samsung)
Waltham, MA, United States
ninad70@gmail.com
Nirav Sevak
Regulatory Affairs
Nostrum Laboratories, Inc.
Kansas City, MO, United States
nsevak@nostrumlabs.com
Noah Papas
Chief Technology Officer
Abililife
Pittsburgh, PA, United States
noah@abililife.com
Nuha Nazy
CEO
Z-axis Lab
Chicago, IL, United States
nuha@zaxislab.com
Nina Ruiz
Manager- Regulatory Compliance and
Sustainability
Conair Corporation
Stamford, CT, United States
nina_ruiz@conair.com
Nithin Ramadurai
Senior Engineer, Product & Process
Development
Olivo Labs, LLC
Cambridge, MA, United States
nithin@olivolabs.com
Obaid Ali
Federal Inspector of Drugs
Drugs Regulatory Authority of Pakistan
Karachi, Non-US, Pakistan
oarohama@gmail.com
Odelya Lazimi
director of international trade policy
Israeli Embassy
Washington, DC, United States
odelya.lazimi@israeltrade.gov.il
Odessa Quintyne
Director of Quality and Regulatory Affairs
Biorep Technologies
Miami, FL, United States
odessa@biorep.com
Odeya Tsur
Regulatory Affairs Department
CTS Pharmaceutical Industries Ltd
Hod Hasharon, Non-US, Israel
odeya@cts.co.il
Odunayo Obisesan
VP, Clinical Services
MedicPharm Inc
Highland, MD, United States
medicp06@gmail.com
Oiza Kuyinu
Research Specialist Ophthalmology
The Emmes Corporation
Rockville, MD, United States
ykuyinu@emmes.com
Olivia Lau
Microbiology/Regulatory Specialist
Beaver-Visitec International
Waltham, MA, United States
olivia_lau@beaver-visitec.com
Olof Ljunghusen
CEO
Science and Innovation AB
Lund, Non-US, Sweden
olof.ljunghusen@scienceandinnovation.se
Oluoje Karma Dele
Personnel Executive
Zeemorg Resources Limited
Lagos, Non-US, Nigeria
karmdel@gmail.com
Oluyinka Green
Regulatory Consultant
Concert Pharmaceuticals
Lexington, MA, United States
ogreen@concertpharma.com
Orandrach Drach
Managing Director
Defense-Lab
Givat Ada, Non-US, Israel
od@defense-lab.com
Oussama Hassan
Medical director
Analog Medical Technologies LLC
Austin, TX, United States
oussama_has@hotmail.com
Pam Rocksted
Senior Regulatory and Quality Specialist
Regulatory and Quality Solutions
Westminster, CO, United States
pamrocksted@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Pamela Fitzpatrick
Director RA Clinical
Amneal Pharma
Hauppauge, NY, United States
pfitzpatrick@amneal.com
Pamela Mason
Vice President, Quality and Compliance
MPS, LLC
Chicago, IL, United States
pmason8736@msn.com
Paola Lucchetti
Responsible for exporting procedures
BYM! S.r.l.
Caserta, Non-US, Italy
paola.lucchetti@gmail.com
Patricia Ryan
Senior Manager, Regulatory Affairs
La Jolla Pharmaceutical Company
San Diego, CA, United States
pryan@ljpc.com
Patricia Bewley
Project Manager
US Army MRMC
Frederick, MD, United States
patricia.a.bewley.ctr@mail.mil
Patricia Karausky
RN_ Research Facilitator
University of Pittsburgh/CTSI
Pittsburgh, PA, United States
plk1@pitt.edu
Patricia Maguire
Regulatory Scientist
TekTeam LLC
Palo Alto, CA, United States
patti@tekteam.net
Patricia Egea
Regulatory Affairs Specialist,
Pharmacovigilance
Catalent Pharma Solutions
St. Petersburg, FL, United States
patricia.egea@catalent.com
Patricia Termini
Manager Regulatory Affairs
Chiltern International
Cary, NC, United States
Patricia.Termini@chiltern.com
Patrick Baker
Oakworks
Oakworks, Inc
New Freedom, PA, United States
pbaker@oakworks.com
Patrick Lim
QA/RA manager
Hiossen Inc.
Fairless Hills, PA, United States
dtlim@osstem.com
Patrick Lim Soo
Senior Scientist
Blend Therapeutics
Watertown, MA, United States
plimsoo@blendtx.com
Paul Buccetti
RF
Aplicare
Meriden, CT, United States
paul.buccetti@clorox.com
Paul Ginos
Director of Manufacturing
Klocke of America Inc.
Ft Myers, FL, United States
paul.ginos@klockeamerica.com
Paula Costa
Analisty
Prati Donaduzzi
Toledo, Non-US, Brazil
paula.costa@pratidonaduzzi.com.br
Paulette Midgette
Manager, Regulatory Affairs
Accenture
Philadelphia, PA, United States
paulette.midgette@accenture.com
Paulette Midgette
Manager, Regulatory Affairs
Accenture
Philadelphia, PA, United States
paulette.midgette72@msn.com
Pavadi Subramaniam
Senior Manager
OHM LABS INC
New Brunswick, NJ, United States
subramaniam.pavadi@ranbaxy.com
Pedro Paz
Director of Quality
Cerno Pharmaceuticals
Hialeah, FL, United States
ppaz@cernopharma.com
Pelumi Badmus
President
Hero's Shelter, Inc.
Hesperia, CA, United States
pelu@heroshelter.org
Penelope Ernould
Quality Engineering Manager
SCIEX
Concord, Non-US, Canada
penelope.ernould@sciex.com
Penelope Ward
Chief Medical Officer
Karus Therapeutics Ltd
Oxford, Non-US, United Kingdom
p.ward@karustherapeutics.com
Peter Grier
Sr. Manager
mantech
columbia, MD, United States
peter.grier@mantech.com
Peter Scott
Sr Director Regulatory Affairs
Immucor
Warren, NJ, United States
pscott@immucor.com
Peter Webner
SVP
Zevacor Molecular
Noblesville, IN, United States
webnerp@gmail.com
Peter Ohanian
Principal
NorthShore Quality and Regulatory
Solutions, LLC
Windham, NH, United States
peter.ohanian@northshoreqrs.com
Peter Wu
Head of QC
ChemPacific Corporation
Baltimore, MD, United States
pwu@chempacific.com
Phani Puppala
Quality Coordinator
Arthrosurface
Franklin, MA, United States
phaniblaze@gmail.com
Phil Triolo
Sr. Consultant
Phil Triolo and Associates LC
Salt Lake City, UT, United States
philt.philt@gmail.com
Phil Wyman
CEO/President
Digital Hospital, Inc.
San Jose, CA, United States
phillipswyman@gmail.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Ping Lin
research scientist
Simcere Pharmaceutical Group
Nanjing, Non-US, China
linpingmary@gmail.com
Pj Pardo
Director, Regulatory & Clinical Affairs
Organ Recovery Systems
Itasca, IL, United States
ppardo@organ-recovery.com
Prabhakar Thota
Sr. Manager
Biological E Ltd
Hyderabad, Non-US, India
prabhakar.thota@biologicale.co.in
Pradeep Jandhyala
Manager
EMC
Sydney, Non-US, Australia
Pradeep.jandhyala@emc.com
Pragnya Bakka
Regulatory affairs coordinator
Syneron-Candela
Boston, MA, United States
pragnyareddy.9@gmail.com
Prajakta Palshikar
Manager - Regulatory Affairs
Alpha MD Pvt Ltd
Mumbai, Non-US, India
prajakta.palshikar@alphamd.com
Prajit Acharya
Senior Research
Indian Council of Medical Research
Delhi, WI, India
prajitacharya@outlook.com
Prasanna Palle
Regulatory Affairs Associate I
Amneal Pharmaceuticals
Hauppauge, NY, United States
ppalle@amneal.com
Prashant Vagadia
Executive
Sun Pharmaceutical Industries Ltd.
Vadodara, Non-US, India
prashant.vagadia@gmail.com
Praveenkumar Aluru
Associate scientist
Syngene international
bengalore, Non-US, India
praveenkumar.reddyaluru@syngeneintl.co
m
Priscilla Ejimofor
CEO
Regina Mundi Inc
Jacksonville, FL, United States
Reginamundi3@aol.com
Praveenkumar Patil
Academia
Government Medical college
Dhule, Non-US, India
drpraveentpatil@yahoo.in
Prema Krishna
Drug Safety PVG consultant
Freelanace-Drug Safety
Chester Springs, PA, United States
prema.krishna@icloud.com
Prithul Bom
Senior Director
CHILTERN
Minneapolis, MN, United States
prithul.bom@chiltern.com
Priti Rajda
DGM-Regulatory Affairs
Ipca Laboratories Limited
Mumbai, Non-US, India
priti.rajda@ipca.com
Pushpa Makkikana
Prinicipal Quality Consultant
WIPRO LIMITED
Bangalore, Non-US, India
pushpa.makkikana@wipro.com
Qiang Cao
Quality Assurance and Regulatory Affairs
IZI Medical Products
Owings Mills, MD, United States
qiang.cao@izimed.com
Qin Li
staff fellow
FDA
Silver Spring, MD, United States
Qin.Li@fda.hhs.gov
Qun Zhang
Sr. Manager
Prinston Pharmaceutical Inc.
cranbury, NJ, United States
qun.zhang@huahaipharmus.com
R. William Soller, Phd
President
Soller Regulatory & Research Services, d
Houston, TX, United States
rwsoller@outlook.com
Radha Ramesh
Head of assurance, life sciences
TCS
Bridgewater, NJ, United States
radha_19462@yahoo.com
Rafael Comas
Head of Regulatory Affairs
PROCAPS S.A.
BARRANQUILLA, Non-US, Colombia
rcomas@procaps.com.co
Rafael Gaitan
Partner
Suarez Gaitan
Coral Gables, FL, United States
rg@suarezgaitanlaw.com
Raghavendra A
Consultant
WIPRO LIMITED
Bangalore, Non-US, India
raghavendra.a24@wipro.com
Raghunadha Reddy Seelam
Post Doc
University of Maryland
Baltimore, MD, United States
raghu_nathseelam@yahoo.co.in
Raghunandhan Painoori
Assistant Manager
Novel Laboratories, Inc.
Somerset, NJ, United States
praghunandhan@novellabs.net
Ragunath Muniandy
Regulatory Affairs Specialist
Black Diamond Video
Richmond, CA, United States
ragu_4@hotmail.com
Rahul Raj
Sr.Executive
iMEDGLOBAL
Banglore, Non-US, India
rahuldeolraj@gmail.com
Rajani Gandhari
Regulatory Associate
Igi labs
Buena, NJ, United States
rajanigandhari@igilabs.com
Rajesh Kalle
Software Engineer
HCL Technologies
Chennai, TN, Indonesia
kalle.r@hcl.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Rajesh Kumar Dharmireddy
Senior Executive
Mylan
Bangalore, Non-US, India
rajesh.dharmireddy@mylan.com
Rajesh Pasupuleti
Solution Architect
HCL
Chennai, Non-US, India
rajeswararao.p@hcl.com
Rajib Baishnab
Executive, Global Regulatory Affairs
Square Pharmaceuticals Ltd., Bangladesh
Dhaka, Non-US, Bangladesh
cantrajib@gmail.com
Rakesh Chaurasia
Head Drug Regulatory Affairs
PT DexaMedica
Tangerang, Non-US, Indonesia
rakesh.chaurasia@dexa-medica.com
Rakhi Dalal
Toxicologist
US FDA
Silver Spring, MD, United States
Rakhi.Dalal@fda.hhs.gov
Rambabu Mogali
Assistant.General Manager
Raks pharma Pvt. Ltd (Amneal group)
Visakhapatnam, Non-US, India
rambabum@rakspharma.com
Rana Tbaishat
academic advisor
SACM
sterling, VA, United States
rana_tt3@hotmail.com
Raphaël Guillot
Consultant
The Biotech Quality Group
Neuchatel, Non-US, Syria
raphael.guillot@live.fr
Rashid Mureed
Manager
PharmEvo Pvt. Ltd. Pakistan
Karachi, PA, Pakistan
rashid.mureed@pharmevo.biz
Rashmika Patel
Protocol coordinator
NIH
rockville, MD, American Samoa
Patelra@mail.nih.gov
Ravikiran Gouni
Executive-Regulatory Affairs
Amneal Pharmaceuticals
Ahmedabad, Gujarat, Non-US, India
ravig@amnealindia.com
Raymond Austin
QA Engineer
MES Ltd
Netanya, Non-US, Israel
raymondisr@gmail.com
Rebecca Cuniff
Senior Regulatory Affairs Associate
First Priority, Inc.
Elgin, IL, United States
bcuniff@prioritycare.com
Rebecca Spelich
Sr. Regulatory and Quality
R&Q
Akron, OH, United States
rspelich@rqteam.com
Rebekah Morrow
Product Regulatory Representative
Eastman Chemical Company
Kingsport, TN, United States
rfmorrow@eastman.com
Reji Paalangara
As Pr Scientist
Merck Animal Health
Madison, NJ, United States
reji.paalangara@merck.com
Rem Siekmann
Principal Engineer
R&Q Solutions LLC
Monroeville, PA, United States
rsiekmann@rqteam.com
Renae Dixon
Associate Directory of Regulatory Affairs
Century Pharmaceuticals
Indianapolis, IN, United States
RenaeD@dakins.net
Renata Lavach
Regulatory Strategist
Scimedx Corporation
Dover, NJ, United States
rlavach@scimedx.com
Rene Flores
VP Operations
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
rene.flores@dgfgroup1.com
Renuka Krishnan
Director, Regulatory Affairs
Obalon Therapeutics
San Diego, CA, United States
Rkrishnan@Obalon.com
Reshmi Rose
Technical Lead
Wipro Technologies
Boulder, CO, United States
reshmi.rose@wipro.com
Revathi Chapa
scientist
Dr.Reddys
hyderabad, IN, India
revathichapa@drreddys.com
Rhonda Alexander
Senior Regulatory Specialist
Registrar Corp
Hampton, VA, United States
ralexander@registrarcorp.com
Richard Ferguson
Assoc. Director of Production
Wes Pharma
Westminster, MD, United States
rferguson@wespharma.com
Richard Lee
Regulatory Compliance Analyst
Stryker Endoscopy
San Jose, CA, United States
richard.lee@stryker.com
Rick Fletcher
QA Director
CHALGREN ENTERPRISES
GILROY, CA, United States
rfletcher@chalgrenenterprises.com
Rick Gaykowski
Corp. VP, Regulatory/Quality/Clinical
Affairs
Perseon
Salt Lake City, UT, United States
rgaykowski@perseonmedical.com
Rick Wallsten
Consultant
Mount Sinai
Rye, NY, United States
rwallsten@gmail.com
Robert Bard
Managing Director
HTC LLC
Northville, MI, United States
rbard@reglaw.net
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Robert Bradley
Quality Engineer
Cell Solutions
Greensboro, NC, United States
rbradley@cellsols.com
Robert Howard
Manger, Regulatory Affairs
NASP
Franklin, NJ, United States
robh@naspco.com
Robert Lee
regulatory affairs specialist
abbott medical optics
Sunnyvale, CA, United States
regulatory-affairs@outlook.com
Roberta Ziccarelli
Clinical Drug Editor (Pharmacist)
Wolters Kluwer
Indianapolis, IN, United States
roberta.ziccarelli@wolterskluwer.com
Roie Dahan
Co-Founder and Manager
ORRAD Software ltd.
Yakum, Non-US, Israel
roie@orradsoftware.com
Ronny Brown
Branch Chief
FDA/CDRH
Silver Spring, MD, United States
ronny.brown@fda.hhs.gov
Robert Kowal
Director, Risk Management and Criticality
Analysis
Janssen Pharmaceutical
Raritan, NJ, United States
rkowal@its.jnj.com
Robin Gergen
Manager of Standards and Product
Compliance
The ROHO Group
Belleville, IL, United States
robin.gergen@permobil.com
Roohi Bano Obaid
Deputy Drugs Controller
Drug Regulatory Authority of Pakistan
Karachi, Non-US, Pakistan
rooahama@gmail.com
Rory Krieger
founder
ABC2ZEN, LLC
Lakewood, CO, United States
rfkone@earthlink.net
Rosa Hsieha
Project Manager
NYU School of Medicine
New York, NY, United States
rosa.hsieh@nyumc.org
Rosa Lugo
Compliance Consultant
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
rosa.lugo@dgfgroup1.com
Rose Zhao
Managing Director
Emprise Pharma LLC
Phoenixville, PA, United States
zhaor@EmprisePharma.com
Rosetta Cavallo
President
Cavallo Research Associates, LLC
Darnestown, MD, United States
rcfish1@verizon.net
Ruchir Dave
Senior Executive
iMEDGlobal Solutions Pvt. Ltd
Bangalore, Non-US, India
ruchirdave2002@gmail.com
Rudy Darju-Doe
Quality Manager
VGI medical
St Petersburg, FL, United States
rdoe@vgimedical.com
Ruth Cavanagh
CMC Regulatory Affairs Executive
DS Biopharma
Dublin, Non-US, Ireland
r.cavanagh@dsbiopharma.ie
Ruth Collins
Senior Regulatory Affairs Associate II
Sovereign Pharmaceuticals, LLC
Fort Worth, TX, United States
rcollins@sovpharm.com
Ryan Ledwig
Operations & Project Manager
Practical Compliance
Brevard, NC, United States
ryan@practicalcompliance.com
Sabir Afzal
Sr. Rwgulatory Associate
APCER Pharma
New Delhi, Non-US, India
sabir.afzal@apcerls.com
Sabrina Noorani
Clincal Strategist
AbiliLife
Pittsburgh, PA, United States
sabrina_noorani@yahoo.com
Sabrina Sharif
Regulatory Affairs Coordinator
S4Optik LLC
Tonawanda, NY, United States
ra@innovamed.com
Sagar Pimpalwar
Sr. Regulatory Affairs specialist
Steris
Mentor, OH, United States
spimpalwar@usendoscopy.com
Sailaja Chirravuri
officer regulatory affairs
Mylan
Bangalore, Non-US, India
chirravurisailaja@gmail.com
Sailaja Chirravuri
officer regulatory affairs
Mylan
Bangalore, Non-US, India
sailaja.niper@gmail.com
Sajeeh P Ahammed
Quality Assurance
Julphar
Ras Al Khaimah, Non-US, United Arab
Emirates
sajeeh@live.com
Sam Wong
Regulatory Affairs Advisor
Neo Tech
San Marcos, CA, United States
Samuelwong@sandiego.edu
Sally Berry
Chief Medical Officer
Tris Pharma
Monmouth Junction, NJ, United States
sberry@trispharma.com
Salvadore Palomares
Vice President of Quality and Regulatory
Integra Biotechnical
Carlsbad, CA, United States
sal.palomares@integrabio.com
Samantha Kaltenbach
Quality Assurance Specialist
ISTO Technologies, Inc.
St. Louis, MO, United States
skaltenbach@istotech.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Samuel Portnoff
Director of Product Development
Widetronix
Ithaca, NY, United States
sportnoff@widetronix.com
Sandesh Shetty
regulatory affairs senior executive
strides arcolab limited
bangalore, Non-US, India
sandeshshetty11@gmail.com
Sandhyarani Kosuri
Manager
Belcher Pharmaceuticals LLC
Largo, FL, United States
sandhyar@belcherpharma.com
Sandi Ordog
Manager Quality Systems
SCIEX
Concord, Non-US, Canada
sandi.ordog@sciex.com
Sandra Anderson
Associate Director, Regulatory Affairs
Teva Pharmaceuticals
Miami, FL, United States
sandra.anderson@tevapharm.com
Sandra Kircus
Manager, Regulatory Affairs CMC
Genzyme, A Sanofi Company
Boston, MA, United States
sandra.kircus@sanofi.com
Sandy Figueroa
RA/QA Manager
Nubenco Enterprises Inc.
Paramus, NJ, United States
sfigueroa@nubenco.com
Sandy Liu
Senior Engineer
ITRI
Tainan, Non-US, Taiwan
csliusandy@gmail.com
Sandy Yu
QA Manager
Alliance Pharma
Malvern, PA, United States
Syu@alliancepharmaco.com
Sang Min Shin
Manager
GCC
Yongin, Non-US, South Korea
SangMin.Shin@outlook.com
Sanjay Gupta
Manager, Regulatory Affairs
Zoll Manufacturing Corporation
Pittsburgh, PA, United States
sgupta@zoll.com
Sanjay Pradhan
R&D Regulatory Scientist
Nanoscope Technologies
Arlington, TX, United States
pradhan24@yahoo.com
Sanket Trivedi
Regulatory Affairs Associate
Insmed Inc
Bridgewater, NJ, United States
sanket.trivedi@insmed.com
Sanobar Parkar
Global Head and Director
Alpha MD Private Ltd
Mumbai, Non-US, India
drparkar@alphamd.com
Sara Siegler
CEO/Owner
Sara Elizabeth Siegler
Bedford, OH, United States
sara@saraelizabethsiegler.mygbiz.com
Sarah Bakker
Regulatory Affairs Associate
ACIC Fine Chemicals Inc.
Brantford, Non-US, Canada
sbakker@acic.com
Sarah Ellison
Regulatory Compliance Analyst
Stryker Endoscopy
San Jose, CA, United States
Sarah.Ellison@stryker.com
Sarah Ryu
Research Navigator
Johns Hopkins ICTR
Baltimore, MD, United States
sryu5@jhu.edu
Sarat Chandra Allena
Executive
GeneriCo LLC
Bangalore, Non-US, India
saratchandraallena@gmail.com
Sarika Pardhe
AGM -regulatory affairs
Flamingo Pharmaceuticals Ltd
Mumbai, Non-US, India
sarikapardhe@flamingopharma.com
Sartaj Kaur-Hurrle
Quality and Regulatory Specialist
Evofem, Inc
San Diego, CA, United States
sartaj@evofem.com
Sathya Ganesan
Regulatory Coordination manager
Grifols
Durham, NC, United States
Sathya.Ganesan@grifols.com
Satish Tripathi
Senior Vice President
Ophthotech
Princeton, NJ, United States
Satish.tripathi@ophthotech.com
Satya Ganti
VP (R&D)
WES Pharma Inc
Westminster, MD, United States
sganti@wespharma.com
Scott Garrand
Regulatory Affairs Manager
PPD, Inc. Contractor for USAMMDA/US
Army
Fort Detrick, MD, United States
scott.c.garrand.ctr@mail.mil
Seema Paliwal
Regulatory Affairs Specialist II
CardioFocus Inc.
Marlborough, MA, United States
SPaliwal@CardioFocus.com
Scott Zhang
Head of Quality and Regulatory Ultrasound
Philips
Andover, MA, United States
scott.zhang@philips.com
Sean Spence
Regulatory Affairs Manager
NICO Corporation
Indianapolis, IN, United States
Sean.Spence1@gmail.com
Sekar Thirugnanam
Design engineer
HCL technologies Ltd
Chennai, Non-US, India
sekar.t@hcl.com
Selvaraja Elumalai
Manager
Appco Pharma LLC
Somerset, NJ, United States
selvaraja.elumalai@appcopharma.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Serena D'Souza
Regulatory Compliance and Enforcement
Advisor
Health Canada
Ottawa, Non-US, Canada
serenaanndsouza@gmail.com
Shaeann Cavanagh
Regional RA Manager
Agfa HealthCare
Greenville, SC, United States
shaeann.cavanagh@agfa.com
Seung Taek Oh
Director
HPI INC
Rockville, MD, United States
seungtaek5@gmail.com
Seung Yoo
General Manager
Access Bio, Inc.
Somerset, NJ, United States
suyoo@accessbio.net
Shagufta Sultan
Biostatistician
Health Canada
Ottawa, Non-US, Canada
shagufta.sultan@hc-sc.gc.ca
Shahid Saleem
Owner
Zellers
lahore, Non-US, Pakistan
zellers@cyber.net.pk
Shai Melcer
Executive Director
BioJerusalem
Jerusalem, Non-US, Israel
shai@biojerusalem.org.il
Shanaye Carr
QA Representative
AMS Diagnostics LLC
Weston, FL, United States
sc@amsdiagnostics.com
Shannon Kauffman
Quality Manager
Micropore, Inc.
Elkton, MD, United States
shannon.kauffman@microporeinc.com
Shannon Valenti
Regulatory Compliance Facilitator
University of Pittsburgh
Pittsburgh, PA, United States
shannon.valenti@pitt.edu
Shariq Mehmood
Sr. Executive Regulatory Affairs
Scilife Pharma Private Limited
Karachi, Non-US, Pakistan
shariqmehmood7@gmail.com
Sharon Briggs
Sr. Manager, Regulatory Affairs
Medtronic
Jacksonville, FL, United States
sharon.a.briggs@medtronic.com
Shawn Waynick
Regulatory Compliance Assistant
Permobil Inc.
Lebanon, TN, United States
shawn.waynick@permobil.com
Sheila Bello-Irizarry
Integrated Product Development Associate
Rho, Inc.
Chapel Hill, NC, United States
sheila_bello-irizarry@rhowolrd.com
Sheila Kaplan
Washington Correspondent, STAT
Boston Globe Media
Washington, DC, United States
Sheila.Kaplan@statnews.com
Shelby Becker
Regulatory and Quality Associate
Berlin Heart
The Woodlands, TX, United States
shelby.becker@berlinheart.com
Sheri Glaub
Sr. Consultant
RMC Pharmaceutical Solutions
Longmont, CO, United States
sglaub@rmcpharma.com
Sherry Gregor
SVP Regulatory & Quality
A-S Medication Solutions LLC
Libertyville, IL, United States
sgregor@a-smeds.com
Sherry Qiu
QA Manager
ChemPacific Corporation
Baltimore, MD, United States
sqiu@chempacific.com
Shikha Shukla
Regulatory Specialist
Siemens HealthCare Diagnostics
Tarrytown, NY, United States
Shikha.Shukla@siemens.com
Shilpa Patel
Sr. RA Project Manager
Perrigo Company
Allegan, MI, United States
shilpa.patel@perrigo.com
Shiying Tian
Associate Director
Abonpharmaceuticals
Northvale, NJ, United States
shiying.tian@abonpharma.com
Shokoufeh Khodabandeh
Quality System Specialist
Profound Medical Inc.
Toronto, Non-US, Canada
skhodabandeh@profoundmedical.com
Shoshi Kaganovsky
CEO
Alsho
Tel Aviv, Non-US, Israel
shoshi@alsho.com
Shradha Gottumukkala
Regulatory Affairs Associate
Professional Disposables International, Inc.
Montvale, NJ, United States
shradha.gottumukkala@pdipdi.com
Shree Koushik
Regulatory Scientist
Clinical RM
Damascus, MD, United States
svkoushik@gmail.com
Shruti Prasad
Chemist
WES Pharma Inc
Westminster, MD, United States
sprasad@wespharma.com
Shuiqing Qiu
Postdoc fellow
Johns Hopkins University
Baltimore, MD, United States
sqiu6@jhmi.edu
Shuyen Huang
Director, CMC
JTIHuang
RIVERWOODS, IL, United States
sybd0527@outlook.com
Simone John
Regulatory Affairs Specialist
National Cancer Institute
Rockville, MD, United States
johnsi@mail.nih.gov
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Sindhura Gaddamanugu
Regulatory Affairs Specialist
Ocular Therapeutix, Inc.
Bedford, MA, United States
sgaddamanugu@ocutx.com
Sireesha Alla
Senior Regulatory Associate
InnoPharma
Piscataway, NJ, United States
sireesha.alla@pfizer.com
Sista Sugiarto
Quality Assurance Engineer
Varian Medical Systems
Palo Alto, CA, United States
sista.sugiarto@varian.com
Snigdha Bezawada
Regulatory Operations Manager
CCS Associates
Mountain View, CA, United States
snigdha.b20@gmail.com
Sohail Bashir
QA Manager
Standpharm Pakistan Ltd.
Lahore, WY, Pakistan
sbarain@gmail.com
Soma Kalb
Director, IDE Program
FDA
Silver Spring, MD, United States
Soma.kalb@fda.hhs.gov
Sonia Wu
Senior Manager
Archigen Biotech Limited
Seoul, Non-US, South Korea
sonia.wu@archigenbio.com
Sonia Haley
Regulatory consultant
Regulatory consulyant
Richmond, VA, United States
shvbsetter@comcast.net
Sophie Payannet
Administrative Coordinator
Asklepion Pharmaceuticals LLC
Baltimore, MD, United States
sophie.payannet@asklepionpharm.com
Sophy Abraham
Head of Regulatory Affairs
Elite Laboratories Inc.
Northvale, NJ, United States
sabraham@elitepharma.com
Spencer Jarvis
Regulatory Manager
Nu Skin Enterprises
Provo, UT, United States
sjarvis@nuskin.com
Srinesh Naidu
Formulation Associate
Appco Pharma LLC
Somerset, NJ, United States
srinesh.naidu@appcopharma.com
Srinivas Yandrapu
Associate Director
Dr.Reddy's Laboratories
Princeton, NJ, United States
syandrapu@drreddys.com
Stacey Murakami
Radiopharmacist/ QA Officer
Queens Medical Center
Honolulu, HI, United States
stmurakami@queens.org
Stacie Wehling
Consultant
SciLucent, LLC
Herndon, VA, United States
s.wehling@scilucent.com
Stacey Harveyreid
Program Manager Small Business and
Entreprenuership
Maryland Department of Business and
Economic Development
Baltimore, MD, United States
Stacy
Ralston
stacey.harvey-reid@maryland.gov
Clinical & Regulatory Director
Molecular Matrix
Davis, CA, United States
seralston@molecularmatrix.com
Steph Cooke
President
Cooke Consulting
Acworth, GA, United States
stephcooke3@gmail.com
Stephanie Skipper
Principal Consultant
Ticalion Quality Management Services
Chesapeake, VA, United States
Sskipper@ticalionllc.com
Stephanie Bechtold
Biomedical Engineer
Food and Drug Administration
Silver Spring, MD, United States
stephanie.bechtold@fda.hhs.gov
Stephanie Harrington
Chief Executive Officer
Matrix Medical Devices LLC
Mentor, OH, United States
sharrington@matrixmedicaldevices.com
Stephanie Mendy
Law Clerk
Suarez Gaitan
Coral Gables, FL, United States
srm@suarezgaitanlaw.com
Stephanie Mizell
Clinical Trials Manager
General Dynamics Information Technology
Frederick, MD, United States
stephanie.e.mizell.ctr@mail.mil
Stephen Haley
Chief Commercial Officer
Immudex
Fairfax, VA, United States
sh@immudex.com
Stephen Weitzman
Exec. Dir
MedDATA Foundation
Columbia, MD, United States
saw5198@earthlink.net
Steve Krueger
Principal Consultant
MAK and Associates, LLC
Milwaukee, WI, United States
steve@makcompliance.com
Steve Wolf
VP - QA & Regulatory
MedTorque, Inc.
Kenosha, WI, United States
swolf@strongprecision.com
Steven Abrams
Partner
Pepper Hamilton LLP
Philadelphia, PA, United States
abramss@pepperlaw.com
Steven Demarco
Dir Preclinical Development
Ra Pharma
Cambridge, MA, United States
sdemarco@rapharma.com
Stanley Huang
Research Fellow
FDA/CDRH
Silver Spring, MD, United States
stanley.huang@fda.hhs.gov
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Steven Jones
Regulatory Affairs
Noramco, Inc.
Athens, GA, United States
sjones@its.jnj.com
Steven Peltier
VP Regulatory and Quality Compliance
Rcordati Rare Diseases Inc
Lebanon, NJ, United States
Peltier.S@Recordati.com
Storm Stillman
Co-Founder and CEO
Luminist
Coral Springs, FL, United States
storm@luminist.io
Stuart Crowther
Senior Regulatory Specialist
Varian Medical Systems
Crawley, Non-US, United Kingdom
stuart.crowther@varian.com
Subhas Malghan
Deputy Director
Food and Drug Administration
Silver Spring, MD, United States
Subhas.Malghan@fda.hhs.gov
Sudhakar Bandari
President
Aurex Labs
East Windsor, NJ, United States
Sudhakar.bandari@aurexlabs.com
Sue Farina
President
Proveris Scientific Corporation
Marlborough, MA, United States
sfarina@proveris.com
Sue Gifaldi
Senior Compliance Manager
Janssen Pharmaceuticals
Rochester, NY, United States
sgifald@its.jnj.com
Sue Wang
Manager/Tech Consultant
ITRI
ROCKVILLE, MD, United States
wangs0926@gmail.com
Su-Hsiu Wu
Lecturer
University of Rhode Island
Kingston, RI, United States
swu@ele.uri.edu
Sumitra Ravuru
trainee research associate
aurobindo pharma limited
hyderabad, Non-US, India
ravurusumitra@gmail.com
Susan Batchilder
Regulatory Affairs / Proj Mgmt
Dalhousie University
Halifax, Non-US, Canada
susanbatchilder@dal.ca
Susan Brocchi
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
susan.brocchi@siemens.com
Susan Johnston
CEO
Innovate Medical, LLC
Johnson City, TN, United States
susanj@innovatemed.com
Susan Parker
Director Purchasing and Logistics
Kenmark Optical, Inc.
Louisville, KY, United States
susanparker@kenmarkoptical.com
Susan Telliard
Senior Director Regulatory Affairs
Horizon Pharma plc
Deerfield, IL, United States
stelliard@horizonpharma.com
Susi Antoniuk
Director-Regulatory Affairs
Acorda Therapeutics, Inc.
Ardsley, NY, United States
santoniuk@acorda.com
Suzan Davis
President & CEO
Global Regulatory Partners-LLC
waltham, MA, United States
sdavis@globalregulatorypartners.com
Susan Neadle
Head, Combination Products CoE and Sr.
Director, DtV/QE
Janssen Pharmaceuticals
Jacksonville, FL, United States
sneadle1@its.jnj.com
Sushil Jaiswal
Executive Vice President - Corporate
Quality Assurance and Regulatory Affairs
Macleods Pharmaceuticals Limited
Mumbai, Non-US, India
sushil@macleodspharma.com
Suzanne Delaney
Regulatory Affairs Manager
Portola Pharmaceuticals Inc
South San Francisco, CA, United States
delaneysuzanne@yahoo.com
Svetlana Spasova
assessment officer
Health Canada
Ottawa, Non-US, Canada
svetlana.spasova@hc-sc.gc.ca
Syed Sameer
Deputy Manager
Searle
Karachi, Non-US, Pakistan
sameer_phm@hotmail.com
Syed Sameer
Deputy Manager
Searle
Karachi, Non-US, Pakistan
drsm.sameer@gmail.com
Takuya Hagiwara
Manager
Mitsui Chemicals,Inc.
Tokyo, Non-US, Japan
Takuya.Hagiwara@mitsuichemicals.com
Tal Or
ceo
ATLASense Biomed Ltd.
Tel Aviv, Non-US, Israel
talor1105@gmail.com
Tamala Wampler
Consultant QA & RA
Novus Management, LLC
Cincinnati, OH, United States
tamala@novusmgllc.com
Tangela Nichols
Regulatory Analyst
Thermo Fisher Scientific
Frederick, MD, United States
tangela.nichols@thermofisher.com
Tania Lupu
QA-QC Direcdtor
Case Medical
South Hackensack, NJ, United States
tlupu@casemed.com
Tânia Melo
Global Regulatory Compliance Leader
Shamir Optical
Porto, Non-US, Portugal
taniamelo@shamir.pt
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Tanveer Wahid
QA Manager
Dynex Technologies
Chantilly, VA, United States
twahid@dynextechnologies.com
Taragh Keily
Project Manager
University College Cork
Cork, Non-US, Ireland
taragh@gmail.com
Teresa Faulkner
Medical Writer
Rho, Inc.
Chapel Hill, NC, United States
Teresa_Faulkner@rhoworld.com
Terese 'Ter' Sinopoli
Director corporate compliance
Oticon medical
Somerset, NJ, United States
T.sinopoli@comcast.net
Teri Sinopoli
Director of corporate compliance
Oticon medical
Somerset, NJ, United States
Tsin@oticonmedical.com
Terrence Oakes
COO (Chief Operating Officer)
inseRT MRI
Madison, WI, United States
terry.oakes@insertmri.com
Terry Dixon
Director, RA
Catalent Pharma Solutions
St. Petersburg, FL, United States
terry.dixon@catalent.com
Thierry Plouvier
CEO
TERALI
Fondettes, Non-US, France
tplouvier@terali.fr
Thom Demuth
Manager, Regulatory Affairs
Procter & Gamble
Mason, OH, United States
demuth.tp@pg.com
Terry Ingram
Manager Medical Events and Combination
Products
Abbvie
Waukegan, IL, United States
terry.ingram@abbvie.com
Thomas Clark
VP, QA & Prod Dev
Alva-Amco Pharmacal Cos., Inc.
Niles, IL, United States
tclark@alva-amco.com
Thomas Jeffers
VP, Govt. Affairs
Hill-Rom
Washington, DC, United States
tom.jeffers@hill-rom.com
Thomas Sebastian
Senior Scientist
Akonni Biosystems
Frederick, MD, United States
tsebastian@akonni.com
Thrilok P
Jr. Executive Regulatory Affairs
CaplinPoint Laboratories LTD,.
chennai, Non-US, India
p.thrilok@gmail.com
Thu-Ha Duncan
President
PDI Works, LLC
Cleveland, TN, United States
pdiworks@gmail.com
Thomas Cronin
Director of Regulatory Affairs and
Compliance
Actuated Medical, Inc.
Bellefonte, PA, United States
Thomas.Cronin@actuatedmedical.com
Thomas Varricchione
Sr. Vice President, Clinical & Regulatory
Affairs
Ximedica, LLC
Providence, RI, United States
tvarricchione@ximedica.com
Tierra Brown
Regulatory Affairs Specialist
Terumo Cardiovascular Group
Baltimore, MD, United States
tierrabrown82@gmail.com
Tieuvi Nguyen
Branch Chief
FDA
Silver Spring, MD, United States
tieuvi.nguyen@fda.hhs.gov
Tiffany Huang
Consultant
Autotelic Inc.
City of Industry, CA, United States
thuang@autotelic.com
Tiffany Palmer
Biomedical Engineer
FDA
Silver Spring, MD, United States
Tiffany.Palmer@fda.hhs.gov
Tim Quan
RA manager
Elekta
Beijing, Non-US, China
tim.quan@outlook.com
Tim Voeller
Quality Manager
Ducommun
Appleton, WI, United States
tvoeller@ducommun.com
Timothy Good
Senior Quality Engineer
Blue Spark Technologies
Westlake, OH, United States
tgood@bluesparktechnologies.com
Tina Feld
Quality Assurance Assistant
Xcision Medical Systems, LLC
Columbia, MD, United States
tina.feld@xcision.com
Todd Courtney
Branch Chief
FDA
Silver Spring, MD, United States
todd.courtney@fda.hhs.gov
Todd Milholland
Sr. Manager, Regulatory Affairs
Hansen Medical
San Jose, CA, United States
todd_milholland@hansenmedical.com
Tomas Alvidrez
QA Director
salter labs
El Paso, TX, United States
alvidrez.tomas@gmail.com
Tony Du
Epidemiologist
Fda
Silver Spring, MD, United States
ddu001@gmail.com
Tony Raymond
VP of QA/RA and CCO
Gamma Medica, Inc.
Salem, NH, United States
tony.raymond@gammamedica.com
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Towana Elmore
QA Manager
Convenience Valet
Melrose Park, IL, United States
telmore@cvalet.com
Travis Siverson
RA/QA Manager
Birchwood Laboratories LLC
Eden Prairie, MN, United States
TSIVERSON@BIRCHLABS.COM
Tymissha Jackson
Senior Manager
Adaptimmune
Philadelphia, PA, United States
tymissha.jackson@adaptimmune.com
Uday Kompella
Chief Scientific Officer
Ocugen, Inc.
Englewood, CO, United States
Uday.Kompella@ocugen.com
Vagn Rasmussen
Vice President
DELTA
Roskilde, Non-US, Denmark
vagn.rasmussen@privat.dk
Valeria Alcon
scientific evaluator
Health Canada
Vancouver, Non-US, Canada
valeria.alcon@hc-sc.gc.ca
Valeria Weltin
Sr. Regulatory Affairs Associate
Johns Hopkins
Baltimore, MD, United States
vweltin@jhmi.edu
Valerie Ahmuty
Sr. Director, Regulatory Affairs
TherapeuticsMD
Boca Raton, FL, United States
valerie.ahmuty@therapeuticsMD.com
Valerie Shinault
Regulatory Affairs Associate
IGI Laboratories, Inc.
Buena, NJ, United States
valerieshinault@igilabs.com
Vana Poovala
Sr. RA Specialist
Atrium Medical Corp
Hudson, NH, United States
vana.poovala@maquet.com
Vanessa Jacques
QA/RA Manager
Salimetrics
State College, PA, United States
vjacques@salimetrics.com
Varsha Nainani
CEO
Self
Irving, TX, United States
varshanainani@gmail.com
Venkatarao Gaddam
Technical Manager
HCL
Chennai, Non-US, India
venkatarao.g@hcl.com
Venkatreddy Kumbam
senior scientist
ScieGen pharms Inc
Hauppauge, NY, United States
vkumbam@gmail.com
Vesper Ramos
Senior Staff Fellow
FDA CDRH
Rockville, MD, United States
vesperfemarie.ramos@fda.hhs.gov
Vikas Kumar
Senior Research Scientist
Fresenius
Gurgaon, Non-US, India
VIKASBANSAL227@GMAIL.COM
Vikram Krishnamachary
Student
UCLA
Los Angeles, CA, United States
vikramkrish@gmail.com
Viktoriya Knez
Quality Sistem Manager
Bioprod d.o.o.
Ljubljana, Non-US, Slovenia
viktoriya.knez@bioprod.si
Vilma Naupari
Regulatory Affairs Analyst
DEGIMID
LIMA, Non-US, Peru
vnaupari@gmail.com
Virginia Morales
Principal Investigator
Fraternal Association Nuestra Dynastia
Castroville, CA, United States
thelegend831@live.com
Vishal Sachdeva
Research Associate
Sun Pharma Industries Limited
Sriganganagar, Non-US, India
vishalsachdeva888@gmail.com
Viswesh Achanta
RA Executive
Daewoong Pharmaceutical Co Ltd
Hyderabad, Non-US, India
aviswesh@daewoong.co.kr
Vivian Kelly
Regulatory Affairs Manager
Fidia Pharma USA Inc.
Parsippany, NJ, United States
vkelly@fidiapharma.us
Vladimir Roudik
Director of operations
AVAILIUS LLC
Linden, NJ, United States
roudik@availius.com
Wade Halma
Director of Engineering
Evenflo Feeding, Inc.
West Chester, OH, United States
wade.halma@kcc.com
Walter Jump
President, CEO
Cornerstone Regulatory
Langhorne, PA, United States
walterjump@cornerstoneregulatory.com
Warren Crumplin
Regulatory Affairs Supervisor
Fine Chemicals Corporation
Cape Town, Non-US, South Africa
WCrumplin@aspenpharma.com
Wasim Iqbal
Executive QA
kaizen pharmacuticals karachi Pakistan
karachi, Non-US, Pakistan
wasimpharmd@gmail.com
Wei Zhang
Vice President
Youngtech Pharmaceuticals, Inc.
Cranbury, NJ, United States
wei.zhang@youngtechpharma.com
Weiwei Hua
Manager
HPC
EDISON, NJ, United States
whua3@jhu.edu
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Wenyan Liao
QA Compliance Specialist
Shire Pharmacueticals
Cambridge, MA, United States
wliao@shire.com
William Rose
Associate
Axinn, Veltrop & Harkrider
Washington, DC, United States
wrose@axinn.com
William Sutton
Deputy Director
DICE
Silver Spring, MD, United States
william.sutton@fda.hhs.gov
William Daniels
Lab Services Coordinator
Shell Developmental Services &
Laboratories
Colton, CA, United States
Labbtime22@Gmail.com
William Woods
Business Manager
TRI-K Industries
Denville, NJ, United States
bill.woods@tri-k.com
Wolfgang Werner
VP RA&QM
Biovotion AG
Zurich, Non-US, Switzerland
wolfgang.werner@biovotion.com
Wuyi Wang
Director
ChemPacific Corp
Baltimore, MD, United States
wwang@chempacific.com
Xia Yang
assistant
Jiangsu Hansoh
Lianyungang, Non-US, China
sherryyang@hansoh.cn
Xiaoting Wang
Regulatory Affairs Specialist
GW Pharmaceuticals
Durham, NC, United States
XWang@gwpharm.com
Xavier Canals-Riera
Director
Tecno-med Ingenieros Medical Tech
Consultants
Barcelona, Non-US, Spain
xcanals@tecno-med.es
Xiaoting Wang
Regulatory Affairs Specialist
GW Pharmaceuticals
durham, NC, United States
neuro.xtwang@gmail.com
Xiaoxi Wang
QA/QC manager
Advin Biotech
San Diego, CA, United States
wxx254276126@hotmail.com
Xiaoxia Li
Staff
Cleveland Clinic
Cleveland, OH, United States
lix@ccf.org
Ximena Semensato
Regulatory Specialist
Baxter Healthcare
Round Lake, IL, United States
ximena_semensato@baxter.com
Xin Fang
Mathematical Statistician
FDA
Silver Spring, MD, United States
xin.fang@fda.hhs.gov
Xiting Yang
Statistician
FDA/CDRH
Silver Spring, MD, United States
xiting.yang@fda.hhs.gov
Xueru Mu
Marketing director
Shenda Endoscopy
Hackensack, NJ, United States
endoscope.shend@gmail.com
Xuxia Hu
Regulatory Affairs Manager
Reach,Inc
Tianjin, Non-US, China
huxuxia@chinasurg.com
Yaara Meller Ben Ezra
RA
biometrix medical
jerusalem, IL, Israel
yaara@biometrixmedical.com
Yael Goode
Senior Manager, Regulatory Affairs
Impulse Dynamics
Orangeburg, NY, United States
yaelg@impulse-dynamics.com
Yaji Xu
Mathematical Statistician
FDA/CDRH
Silver Spring, MD, United States
yaji.xu@fda.hhs.gov
Yanxing Zhao
senior statistician
Otsuka Pharmaceuticals
Rockville, MD, United States
sophia.zhao@otsuka-us.com
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co. Ltd.
Shanghai, Non-US, China
wangyaolin@yahoo.com
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co.Ltd.
Shanghai, Non-US, China
wangyaolin1212@outlook.com
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co.Ltd.
Shanghai, Non-US, China
wangyaolin@outlook.com
Yaron Segal
CEO
BrainQ
Jerusalem, Non-US, Israel
yaron@brainQ.co
Yasuyuki Shimoura
QA Specialist
Sysmex America Inc.
Lincolnshire, IL, United States
shimouray@sysmex.com
Yelena Rice
Medicines Quality
Eli Lilly and Company
Indianapolis, IN, United States
riceye@lilly.com
Yesmil Pena
Consultant
Consultant
Woodbridge, Non-US, Canada
Yesmilpn@gmail.com
Wilmarie Flores
Consumer Safety Officer
Food and Drug Administration
Silver Spring, MD, United States
wilmarie.flores@fda.hhs.gov
FDA – CDER – REdI Fall Conference 2015– Participant List
These participants granted permission to share their contact information
Yesmil Pena
Consultant
Consultant
Woodbridge, Non-US, Canada
Yesmilpn@hotmail.com
Yi-Cheng Alex Liu
Research Associate
AROG Pharmaceuticals Inc.
Dallas, TX, United States
y.alex.liu@gmail.com
Yoon Jeong Choi
Manager
Genexine Inc.
Seoul, Non-US, South Korea
yoonjeong.choi@genexine.com
Yosh Mantinband
Product Manager
RenalSense ltd.
Jerusalem, Non-US, Israel
yoshm@renalsense.com
Ysabel Sonia Gutierrez Aures
PHARMACYST
DIGEMID
LIMA, Non-US, Peru
sonia9_11@hotmail.com
Yvonne Schleife
Regulatory & Quality Systems Manager
Acoustic MedSystems
Savoy, IL, United States
yschleife@acousticmed.com
Zhijun Zhong
Project Manager
Chinese Medicines (Guangzhou) Ltd.
Guangzhou, Non-US, China
zzj@hgyy.net
Zivjena Vucetic
VP, Global Clin Mkt Dev
Fujirebio
Malvern, PA, United States
vuceticz@fdi.com
Zulema Meares
QA Manager
Zygo Corp
Tucson, AZ, United States
zulema.meares@ametek.com