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
[email protected]
Abdul Rahim
Research Associate
Regeneron Pharmaceuticals
Tarrytown, NY, United States
[email protected]
Abe Wong
VP QARA Global Quality
Phoenix Healthcare Solutions LLC
Ft. Lauderdale, FL, United States
[email protected]
Abhijit Ramachandran
Director
AROG pharmaceuticals
Dallas, TX, United States
[email protected]
Abid Riaz Ahmed
Senior Scientist
Abbott Healthcare
Weesp, Non-US, The Netherlands
[email protected]
Adel Abou-Ali
Director Global Pharmacovigilance
Sanofi Pastuer
Toronto, Non-US, Canada
[email protected]
Adil Gatrad
Quality Compliance
Actavis
Parsippany, NJ, United States
[email protected]
Aditi Patel
Regulatory Specialist
ClinicalRM
Frederick, MD, United States
[email protected]
Adriana Guerrero
Professional Assessor-Pharmacist
I.N.H.R.R.
Caracas, Non-US, Venezuela
[email protected]
Adriana Metz
Software Validation/Process QA Engineer
Sysmex America, Inc.
Lincolnshire, IL, United States
[email protected]
Affan Ali
Production Officer
Macter International Limited
Karachi, Non-US, Pakistan
[email protected]
Aftab Modi
Sr Manager
USV Limited
Mumbai, Non-US, India
[email protected]
Ahmed El Desoky
Senior
Hikma pharma
Cairo, Non-US, Egypt
[email protected]
Ahmed Elsafy
R&D pharmacist
Hikma pharma
giza, Non-US, Egypt
[email protected]
Ahmed Mohamed
reasearch & development pharmacist
Hikma pharma
sixth of october, Non-US, Egypt
[email protected]
Aisha Wellington
Regulatory Affairs Specialist
National Institites of Health
Rockville, MD, United States
[email protected]
Aishia Henderson
Study manager
Novum Pharmaceutical
Las Vegas, NV, United States
[email protected]
Akil Foluke
Quality Assurance Associate
QOL Medical
Wayzata, MN, United States
[email protected]
Alan Martinson
President
Antigen Plus
Cabin John, MD, United States
[email protected]
Alan Ramnath
Regulatory Coordinator
Emmes
Rockville, MD, United States
[email protected]
Albert Deweese
Owner
Good Automation, LLC
Irving, TX, United States
[email protected]
Alejandro Hernandez
HEAD LABORATORY
PISA
GUADALAJARA, AL, Mexico
[email protected]
Aleksandra Eyring
Senior Clinical Research Coordinator
johns Hopkins University
Baltimore, MD, United States
[email protected]
Alex Chaharom
V.P. of Manufacturing Operations
GeNO LLC
Cocoa, FL, United States
[email protected]
Alexandra Mcpherron
Principal Scientist and Head of
Development
MyoTherapeutics
Silver Spring, MD, United States
[email protected]
Alicia Fitzpatrick
EHS Regulatory Manager
The Dow Chemical Company
Bristol, PA, United States
[email protected]
Alexandra Trandafir
Regulatory Affairs Specialist
Profound Medical Inc.
Toronto, Non-US, Canada
[email protected]
Alhanoof Alnafesah
student
MCPHS
Boston, MA, United States
[email protected]
Alicia Plesnarski
Director Global RA Projects
Alcon
Ft. Worth, TX, United States
[email protected]
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
[email protected]
Allyson Anderson
Regulatory Affairs
Sciecure Pharma Inc.
Monmouth Junction, NJ, United States
[email protected]
Alyson Karesh
Team Leader
FDA
Silver Spring, MD, United States
[email protected]
Alyssa Roelli
Quality and Supply Chain Engineer
Medovations
Milwaukee, WI, United States
[email protected]
Amale Hawi
Pharmaceutical Development Consultant
A. Hawi Consulting
Ridgefield, CT, United States
[email protected]
Amber Jones
Sr. Research Program Coordinator II
The Johns Hopkins University
Baltimore, MD, United States
[email protected]
Amen Aradti
Manager
Pamedica
Plainview, NY, United States
[email protected]
Amishkumar Patel
Research Scientist
FTF Pharma
ahmedabad, Non-US, India
[email protected]
Amit Goel
Senior Executive - Regulatory Affairs
Medico Electrodes International Ltd.
Noida, Non-US, India
[email protected]
Amit Sood
Sr. Officer
Sun Pharmaceutical Industries Limited
Chandigarh, Non-US, India
[email protected]
Amy Cicatello
Quality Engineer
IMI
Pompano Beach, FL, United States
[email protected]
Amy Goley
Owner
Hot Work Consulting
Edmond, OK, United States
[email protected]
Amy Paukovits
Director of RA/QA
Gebauer Company
Cleveland, OH, United States
[email protected]
Amy Piccini
Regulatory Affairs Manager
GF Health Products, Inc.
Atlanta, GA, United States
[email protected]
Ana Karina Ulloa Verdín
Analyst Instrumental
Laboratorios PiSA S.A. de C.V.
Guadalajara, Non-US, Mexico
[email protected]
Ana Maria Saaibi
Sr QA Manager
NA
Miami, FL, United States
[email protected]
Ana Ruiz
Solids Regulatory Affairs Head
Laboratorios Liconsa S.A.
Madrid, Non-US, Spain
[email protected]
Anan Copty
Founder and CEO
NIMD Ltd
Jerusalem, Non-US, Israel
[email protected]
Ananda Kumar
President
Lambda Z Technologies, Inc.
Baltimore, MD, United States
[email protected]
Andrea Vowell
Quality Consultant
Black Diamond Networks
Andover, MA, United States
[email protected]
Andreia Evora
Technical Writer
Johnson&Johnson
Schaffhausen, Non-US, Switzerland
[email protected]
Andres Garcia
Founder
Xone Labs Inc.
San Diego, CA, United States
[email protected]
Andrew Baumann
Staff Fellow
FDA
Silver Spring, MD, United States
[email protected]
Andrew Miller
Biomedical Engineer
FDA
Silver Spring, MD, United States
[email protected]
Andrew Raven
Manager of Biostats Unit
Health Canada
Ottawa, Non-US, Canada
[email protected]
Andrew Scothern
Quality Manager
Handicare
Allentown, PA, United States
[email protected]
Andria Werynski
Associate Director, RA/QA
Cutanea Life Sciences
Wayne, PA, United States
[email protected]
Angelica Rivas
Quality Director
MediStem Panama
Panama, Non-US, Panama
[email protected]
Anibal Lopes
QA/QC Director
CiVentiChem
Cary, NC, United States
[email protected]
Anjana Singh
Sr.Executive
Sentiss Pharma Pvt Ltd.
Gurgaon, Non-US, India
[email protected]
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
[email protected]
Ann Holt
QA Director
Andersen Products, Inc.
Haw River, NC, United States
[email protected]
Ann Howard
Reg Assoc
IGI LAbs
Buena, NJ, United States
[email protected]
Ann Howard
Reg Assoc.
IGI labs
Buena, NJ, United States
[email protected]
Ann Marie Gaitan
Partner
Suarez Gaitan
Coral Gables, FL, United States
[email protected]
Ann Robards
Labeling Consultant
Eli Lilly and Company
Indianapolis, IN, United States
[email protected]
Ann Robbins
President
Ann Robbins LLC
Bradenton, FL, United States
annrobbins1[email protected]
Anna Kirk
Regulatory Affairs Specialist
Siemens Medical Solutions, USA, Inc.
Knoxville, TN, United States
[email protected]
Anna Lisa Somera
VP Quality and Regulatory Affairs
Innoblative
Chicago, IL, United States
[email protected]
Anna Voght
Regulatory Affairs Project Manager
Perrigo
Minneapolis, MN, United States
[email protected]
Anne Keane
Director of Regulatory Affairs
Achaogen
San Francisco, CA, United States
[email protected]
Anne Tomalin
President
Therapeutic Products Inc.
Hamilton, Non-US, Canada
[email protected]
Anne-Laure Bailly
Consultant medical & regulatory
TechMD.fr
Paris, Non-US, France
[email protected]
Annette Hormann
Regulatory and Clinical Affairs Manager
Baebies
Durham, NC, United States
[email protected]
Annette Owens
Associate Director, RA
Professional Disposables International Inc
Montvale, NJ, United States
[email protected]
Annie Deogharia
President
Global Pharma Consultants, LLC
Lewis Center, OH, United States
[email protected]
Antonio Olivo
Director
LSL
Chicago, IL, United States
[email protected]
Anurag Patel
Manager
Dr. Reddy's Laboratories Inc.
Princeton, NJ, United States
[email protected]
April Krauss
Associate Director, Pharmacovigilance
UBC
Blue Bell, PA, United States
[email protected]
Arabindakshaya Mishra
DIRECTOR-DEVELOPMENT QUALITY
DR REDDYS LABORATORIES INC
BRIDGEWATER, NJ, United States
[email protected]
Arahman Ghonemey
Project manager
JASPER
Zagazig, Non-US, Egypt
[email protected]
Archana Shekher
Consultant
Consultant
Cary, NC, United States
[email protected]
Ariela Alter
Vp clinical and regulatory
Brainq
Tel aviv, Non-US, Israel
[email protected]
Arshad Ali
Compliance office
Zafa Labortaories
Karachi, Non-US, Pakistan
[email protected]
Artie Kaushik
Manager RA/QA
Gauss Surgical
Los Altos, CA, United States
[email protected]
Artur Shchukin
Regulatory Compliance Specialist
Ampak
New York, NY, United States
[email protected]
Asaf Azulay
CEO
Top Li-Med Technologies LTD
Ramat Gan, IL, Israel
[email protected]
Asher Bazak
QA @ RA Manager
Brainsway
Jerusalem, IL, Israel
[email protected]
Ashley Yeh
assistant scientist
Pharmadax Inc
Taipei, Non-US, Taiwan
[email protected]
Asis Sarkar
Director
Baylor College of Medicine
Houston, TX, United States
[email protected]
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
[email protected]
net
Baban Bhalerao
Sr.Executive
Enem Nostrum Remedies Pvt. Ltd.
Mumbai, Non-US, India
[email protected]
Avinash Dewangan
ASSISTANT GENERAL MANAGER
AMNEAL PHARMACEUTICALS
AHMADABAD, Non-US, India
[email protected]
Baban Bhalerao
Sr. Officer
Enem Nostrum Remedies Pvt. Ltd.
Mumbai, Non-US, India
[email protected]
Bala Kumar
Associate
Shasun Pharmaceuticals Limited
Puducherry, Non-US, India
[email protected]
Balaji Gandhe
RA Project Manager
Perrigo Company Plc
New Hope, MN, United States
[email protected]
Baishali Kanjilal
Deputy Director, Force Health Protection
Division
USAMMDA
Frederick, MD, United States
[email protected]
Balaji Gandhe
RA Project Manager
Perrigo Company
New Hope, MN, United States
[email protected]
Baoying Liu
Health Scientist Administrator
NIH
Rockville, MD, United States
[email protected]
Barbara Hanney
associate
Teva
Horsham, PA, United States
[email protected]
Barbara Ellison
VP, Quality
Elite Laboratories
Northvale, NJ, United States
[email protected]
Bart Waclawik
COO
AMD LASERS
Indianapolis, IN, United States
[email protected]
Bashar Deeb
Product Surveillance Associate
CooperSurgical
Trumbull, CT, United States
[email protected]
Becky Leibowitz
Associate Director
Janssen Pharmaceuticals
Raritan, NJ, United States
[email protected]
Ben Crowder
Director of Product Development
Chinook Medical Gear, Inc.
Durango, CO, United States
[email protected]
Ben Harpster
QA Compliance Specialist
GlaxoSmithKline
Raleigh, NC, United States
[email protected]
Benita Lanzer
Business Development VP
NE Field Diagnostics
Caesarea, Non-US, Israel
[email protected]
Benjamin Kraus
head of manufacturing
Biofrontera
Leverkusen, Non-US, Germany
[email protected]
Benjamin Moses
General Manager
Marina Medical Instruments, Inc
Fort Lauderdale, FL, United States
[email protected]
Betsy Woodall
Sr Mgr, Medical Information
Teva Pharmaceuticals
Frazer, PA, United States
[email protected]
Bev Stefanavage
Staff Engineer- Quality
Animas Corporation
West Chester, PA, United States
[email protected]
Beverly Folmer
Manager, Pharmaceutical Development
Incyte Corporation
Wilmington, DE, United States
[email protected]
Beverly Hillard
CRA
MedSource
Newington, CT, United States
[email protected]
Bhavana Arya
Sr. EHS Associate
Thermofisher scientifis
bangalore, Non-US, India
[email protected]
Bill Blank
VP, Sales and Marketing
EveryClinicalTrial
Wilmington, NC, United States
[email protected]
Bnv Sambasiva Reddy
Asst Manager
Dr Reddys
Hyderabad, Non-US, India
[email protected]
Bobbi Siddoway
Regulatory Specialist
Total Joint Orthopedics
Salt Lake City, UT, United States
[email protected]
Bolesh J. Skutnik
president/owner
BJA ASSOCIATES
West Hartford, CT, United States
[email protected]
Botros Shameih
Responsible Pharmacist
Concept For Pharmacy
Kfar-sava, Non-US, Israel
[email protected]
Baljinder Kaur
Deputy Manager
Nectar Lifesciences ltd
Chandigarh, Non-US, India
[email protected]
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
[email protected]
Bria Beatty
Student Intern
FDA CDRH
Silver Spring, MD, United States
[email protected]
Brian Mabie
Pharmacist in Charge
API
Waterford, MI, United States
[email protected]
Brian Mundo
Quality Manager
Orchid Orthopedic Solutions
Farmington Hills, MI, United States
[email protected]
Bronwyn Mitchell
Executive Assit to the CEO / Quality Coord.
LW Scientific, Inc.
Lawrenceville, GA, United States
[email protected]
Bruce Wyka
CMC Regulatory Affairs
Insmed
Bridgewater, NJ, United States
[email protected]
Bunny Bierman
Regulatory Affairs Manager
Mallinckrodt
Hazelwood, MO, United States
[email protected]
Butros Hallac
CTO
NIMD
Jerusalem, IL, Israel
[email protected]
Byron Arguello
Regulatory Affairs Associate II
Sandoz Inc
Wilson, NC, United States
[email protected]
Caini Liu
Project staff
Cleveland Clinic
Cleveland, OH, United States
[email protected]
Camille Billing
Regulatory Associate
Salvona Technologies
Hamilton, NJ, United States
[email protected]
Carissa Black
Systems Engineer
Syncroness
Westminster, CO, United States
[email protected]
Carla Alongi
QA Manager
CFA Services LLC
Morton Grove, IL, United States
[email protected]
Carla Duke
CEO
3 Point Medical
Sellersburg, IN, United States
[email protected]
Carlos Montoyo
Compliance Consultant
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
[email protected]
Carmelita Varela
Sr. CRA
BioControl Medical
New Hope, MN, United States
[email protected]
Carmen Lam
Sr. RA Specialist
myoscience
Fremont, CA, United States
[email protected]
Carmen Cardona-Mejia
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
[email protected]
Carmen Netto-Merced
Regulatory Affairs Specialist
City of Hope
Duarte, CA, United States
[email protected]
Carol Bailey
Dir RA
OncoGenex
seattle, WA, United States
[email protected]
Carol Chen
Business Development
Diassess
Berkeley, CA, United States
[email protected]
Carol Griffin
Regulatory Scientist
The Clorox Company
Evansville, IN, United States
[email protected]
Carol Kobrin
Director of External Regulatory Affairs
Johns Hopkins University
Baltimore, MD, United States
[email protected]
Carol Marchione
Vice President, Reg Affairs and QA
TetraLogic Pharmaceuticals
Malvern, PA, United States
[email protected]
Carol Winfield
Director of Regulatory Operations
ISPE
Bethesda, MD, United States
[email protected]
Caroline Kissam
Reserach Manager
Upstate Cardiology
Greenville, SC, United States
[email protected]
Carolyn Hoban
vp research
hhc heathcare
hartford, CT, United States
[email protected]
Carolyn Pham
Manager
B. Braun Medical
Irvine, CA, United States
[email protected]
Carrie Brancart
Dir. QA/RA
VIDAR Systems Corporation
Herndon, VA, United States
[email protected]
Carrie Cameron
VP, CRO Services
Clinlogix
Ambler, PA, United States
[email protected]
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
[email protected]
Cat Bens
Quality Assurance Manager
Colorado State University
Ft Collins, CO, United States
[email protected]
Catherine Chew
Deputy Director
FDA DDI
Silver Spring, MD, United States
[email protected]
Catherine Williams
Director, Regulatory Affairs
Wako Life Sciences, Inc.
Mountain View, CA, United States
[email protected]
Celeste Lim
Regulatory Specialist
Allergan
Irvine, CA, United States
[email protected]
Chad Gibson
Project Engineer
Regulatory and Quality Solutions, LLC
Columbus, OH, United States
[email protected]
Chahana Patel
Regulatory Affairs Specialist
ICU medical
Taylorsville, UT, United States
[email protected]
Chander Kazipeta
Head - Global regulatory Affairs
airis PHARMA
Hyderabad, Non-US, India
[email protected]
Chandra Mouli Dubey
Trainee
Shilpa Medicare
Raichur, Non-US, India
[email protected]
Chandrakanth Reddy Vulpala
managing director
flourssh cosmeti & wellbing clincs
hyderabad, Non-US, India
[email protected]
Chandrashaker Akula
Manager Validation
AMRI
Albany, NY, United States
[email protected]
Chao Hsiao
COO
Autotelic Inc.
CIty of Industry, CA, United States
[email protected]
Charles Celeste
Director, Reg Policy and Intel
LEO Pharma
Parsippany, NJ, United States
[email protected]
Changbin Hou
manager
GUANGZHOU RAINHOME PHARM & TECH
CO ., LTD
Guangzhou, Non-US, China
[email protected]
Charles Ditusa
Chief, Office of Quality Management
USAMMDA
Ft. Detrick, MD, United States
[email protected]
Charles Lee
CEO
Molecular Matrix, Inc.
Davis, CA, United States
[email protected]
Charles Stankovic
Principal Scientist
Ash Stevens Inc
Riverview, MI, United States
[email protected]
Charly Duffy
Quality and Regulatory Supervisor
Swissray International, Inc
Piscataway, NJ, United States
[email protected]
Chaudhry Tajammal Hussain
Quality Systems and Standard head
Novartis Pharma
Karachi, Non-US, Pakistan
[email protected]
Chelsea Cabral
chemist
Queen's Medical Center
Honolulu, HI, United States
[email protected]
Chen Hsiao Lu
Marketing Durector
Covalence Biotechnology Co.,Ltd
Taipei, Non-US, Taiwan
[email protected]
Chen Suen
Program director
National Cancer Institute
Poolesville, MD, United States
[email protected]
Chenguang Wang
Assistant Professor
Johns Hopkins Univ
Baltimore, MD, United States
[email protected]
Cheryl Revels
Research Coordinator
Marshfield Clinic
Marshfield, WI, United States
[email protected]
Cheryl Zellmer
Sr. Int'l Trade Compliance Analyst
Medtronicq
Minneapolis, MN, United States
[email protected]
Chien-Hsiang Tang
R&D Director
Lihpao Life Sci. Co.
Taipei, Non-US, Taiwan
[email protected]
Chien-Hui Yang
Regulatory Affair Associate
Inova Diagnostics
San Diego, CA, United States
[email protected]
Chiung Fang Peng
CEO
FUGA BIOTECHNOLOGY CO
TAIPEI, Non-US, Taiwan
[email protected]
Chorom Pak
Cancer Biologist
Cellectar Biosciences, Inc
Madison, WI, United States
[email protected]
Chris Chan
Sr. engineer
ITRI
Hsinchu, Non-US, Taiwan
[email protected]
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
[email protected]
Chris Goodpaster
QC Specialist II
ISTO Technologies
St. Louis, MO, United States
[email protected]
Chris Sasiela
Regulatory Specialist
NHLBI / NIH
Bethesda, MD, United States
[email protected]
Christelle Laot
Technical Fellow
FedEx Express
Memphis, TN, United States
[email protected]
Christin Lydon
Regulatory Affairs Associate
Curis, Inc.
Lexington, MA, United States
[email protected]
Christina Copley
Quality Engineer
Oncore
San Marcos, CA, United States
[email protected]
Christina Miracle
Manager of Regulatory Compliance
Cincinnati Sub-Zero
Cincinnati, OH, United States
[email protected]
Christina Thompson
Quality
Alvix Laboratories
Ocean Springs, MS, United States
[email protected]
Christine Lee
Data Assistant
KCRN Research
Germantown, MD, United States
[email protected]
Christine Lewczuk
Co-Founder, Director ClinOps
RESEARCH ECHO
Toronto, Non-US, Canada
[email protected]
Christine Miller
VP Regulatory Affairs
TherapeuticsMD
Boca Raton, FL, United States
[email protected]
Christine Oswald Tigerman
CRA II
Abbvie/Inventiv
Pacifica, CA, United States
[email protected]
Christoph Görlach
Director Preclinical and clinical R&D
Geistlich
Wolhusen, Non-US, Switzerland
[email protected]
Christopher Cover
Founder and CEO
Crescentium, LLC
New Orleans, LA, United States
[email protected]
Christopher Kent
President & CEO
ODS Medical
Montreal, Non-US, Canada
[email protected]
Christopher Medberry
Senior Regulatory Affairs Specialist
J&J
West Chester, PA, United States
[email protected]
Christopher Rao
Project Manager
Clinical Assistance Programs, LLC
Framingham, MA, United States
[email protected]
Cindi Linville
Director of Quality
Best Sanitizers
Walton, KY, United States
[email protected]
Cindy Lopez
Associate Director, Regulatory Affairs
Regulatory Professionals. Inc
Newark, CA, United States
[email protected]
Cindy Martin
Director, RA
Aerie Pharmaceuticals, Inc.
Irvine, CA, United States
[email protected]
Claudia Sanchez
CHIEF OF LABORATORY
LABORATORIOS PISA FARMACEUTICA
GUADALAJARA, Non-US, Mexico
[email protected]
Claudia Jackson
Regulatory Affairs Specialist
Honeywell HomMed
Brookfield, WI, United States
[email protected]
Claire Murphy
Associate Consultant
Tecno-med Ingenieros Medical Tech
Consultants
Barcelona, Non-US, Spain
[email protected]
Claudine Ashvar
Consultant, CMC
na
SC, CA, United States
[email protected]
Claus-Peter Richter
CTO
Resonance Medical, LLC
Evanston, IL, United States
[email protected]
Clifton Stanfill
V.P. Regulatory Affairs
AvKARE, Inc
Pulaski, TN, United States
[email protected]
Colleen Gang
Product Manager
BIOCHEMICAL DIAGNOSTICS
EDGEWOOD, NY, United States
[email protected]
Corey Olson
Quality and Regulatory Associate
Medovations
Milwaukee, WI, United States
[email protected]
Cris Lebrilla
Director, Quality Assurance
C3 Jian, Inc.
Marina del Rey, CA, United States
[email protected]
Crystal Lewis
Consumer Safety Officer
FDA/CDH
Silver Spring, MD, United States
[email protected]
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
[email protected]
Daisy Rani Devi
Labeling Administrator
Thermo Fisher Scientific
Bangalore, Non-US, India
[email protected]
Daljit Gill
Senior Consultant
DNH Group LLC
Newark, DE, United States
[email protected]
Dallas Kemper
Quality Engineer & FDA Official
Correspondent
Thermo Fisher Scientific
Marietta, OH, United States
[email protected]
Daneris Fernandez
President
DGF Group
San Juan, Non-US, Puerto Rico
[email protected]
Damaris Flores Neris
Document Controls Technical Writer
Janssen Pharmaceutical
Guaynabo, PA, Puerto Rico
[email protected]
Dana Prieto
Quality Control
Alvix Laboratories LLC
Ocean Springs, MS, United States
[email protected]
Daniel Dafonseca
Regulatory Analyst
University Of Miami
Miami, FL, United States
[email protected]
Daniel Joung
Director of Sales and Marketing
Megabio Implant Solutions
Anaheim, CA, United States
[email protected]
Daniel Molina
VP, Strategic Planning
TRI, Inc
Bethesda, MD, United States
[email protected]
Daniela Beccati
Director of Analytical Research and Quality
OLivo Labs
Cambridge, MA, United States
[email protected]
Danielle Quinn
Quality Manager
VLV Associates
East Hanover, NJ, United States
[email protected]
Danny Even-Chen
Q&R Senoir Director
Philips
Haifa, Non-US, Israel
[email protected]
Darcy Difede
Director of Research
University Of Miami - ISCI
MIami, FL, United States
[email protected]
Darcy Teagle
Senior Quality Assurance Specialist
CD Diagnostics
Claymont, DE, United States
[email protected]
Darius Daruwala
Manager Regulatory Affairs
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
[email protected]
Darren Reeves
President
DPDC, LLC
Moseley, VA, United States
[email protected]
Dave Greco
QC Senior Manager
The Mentholatum company
Orchard Park, NY, United States
[email protected]
David Compton
Lead - Toxicologist
Sanofi US
Bridgewater, NJ, United States
[email protected]
David Crook
President
Innovapaedics
Mineola, TX, United States
[email protected]
David Hernandez
Director Regulatory Affairs
Chemo Group
Chatham, NJ, United States
[email protected]
David Jones
FDA SME
59th MDW/ST
Lackland, TX, United States
[email protected]
David Julovich
Research Specialist
UNTHSC
Fort Worth, TX, United States
[email protected]
David Kuchta
QA Mgr
QuadPharma LLC
Clarence, NY, United States
[email protected]
David Pellicciarini
Vice President, RA/QA/EHS
IBA Molecular North America, Inc.
Los Angeles, CA, United States
[email protected]
David Kouchoukos
Director, Combination Products Center of
Excellence
Janssen Pharmaceuticals
Horsham, PA, United States
[email protected]
David Salirrosas
EVALUATOR PHARMACEUTICAL CHEMICAL
DIGEMID-PERU
LIMA, Non-US, Peru
[email protected]
David Weinstock
Attorney
Law Office of David S Weinstock
Weston, CT, United States
[email protected]
David Wright
Senior Director, Regulatory Affairs
Kowa Research Institute
Morrisville, NC, United States
[email protected]
Dawn Carter
Senior Manager of Medical Device
Compliance
MEDHOST
Franklin, TN, United States
[email protected]
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
[email protected]
Dawn Defazio
Director Regulatory Affairs
ASRI
Pittsburgh, PA, United States
[email protected]
Dawn Irons
Systems Engineer
EMC
Springfield, PA, United States
[email protected]
Dawn Li
Sr. Regulatory Specialist
Patterson Companies Inc.
Saint Paul, MN, United States
[email protected]
Dawn Spooner
Associate Director
PerkinElmer
Waltham, MA, United States
[email protected]
Dean Nahman
Medical [email protected] director
PortSight
Tel avi, Non-US, Israel
[email protected]
Deb Evans
Recent PhD
Recent Graduate
Bethesda, MD, United States
[email protected]
Debasish Dwibedi
ASSISTANT MANAGER
SEMLER RESEARCH CENTER
BANGALORE, Non-US, India
[email protected]
Debbie Kosiak
Global QA Manager
Havpak, Inc.
Malvern, PA, United States
[email protected]
Debleena Sinha
Regulatory Affairs Position
Implant Direct LLC
Agoura Hills, CA, United States
[email protected]
Deborah Kearney
CEO
SideX
Pittsburgh, PA, United States
[email protected]
Deborah Crandall
Attorney
Crandall & Assoc
Bethesda, MD, United States
[email protected]
Deborah Freeman
Research Data & Regulatory Coordinator
Phoebe Putney Memorial Hospital
Albany, GA, United States
[email protected]
Debra Bergstrom
Science Program Analyst
NIH
Bethesda, MD, United States
[email protected]
Debra Dow
President
Dow Development Laboratories
Petaluma, CA, United States
[email protected]
Derajram Benival
Scientist
HLL Lifecare Limited
Trivendrum, Non-US, India
[email protected]
Deval Patel
Regulatory affairs Manager
Astral Steritech pvt ltd
Ladera Ranch, CA, United States
[email protected]
Devasena K
Technical manager
Hcl
Chennai, Non-US, India
[email protected]
Devendra Sharma
SR. GENERAL MANAGER
NECTAR LIFESCIENCES LIMITED
CHANDIGARH, Non-US, India
[email protected]
Devendra Kumar Sharma
SR. GENERAL MANAGER
NECTAR LIFESCIENCES LIMITED
CHANDIGARH, Non-US, India
[email protected]
Devendra Sharma
Senior Genral Manager
Nectar Lifesciences Limited
Chandigarh, Non-US, India
[email protected]
Devika Singh
Chief Product Officer
New Prometheus
Bethesda, MD, United States
[email protected]
Devraj Chakravarty
Manager Regulatory Affairs
Shionogi Inc
Florham Park, NJ, United States
[email protected]
Dharmesh Patel
HEAD REGULATORY AFFAIRS
ATUL LIMITED
ATUL, Non-US, India
[email protected]
Dharmesh Patel
Head Regulatory Affairs
Atul Limited
Atul, Non-US, India
[email protected]
Dharmil Patel
Regualatory Affairs and Quality Assurance
Pharbest Pharmaceuticals
Farmingdale, NY, United States
[email protected]
Diana Parra
Student
Student
Pittsburgh, PA, United States
[email protected]
Diana Sloane
Senior Associate
Lachman Consultant Services, Inc.
Westbury, NY, United States
[email protected]
Diana Francis
Vice President, Global Quality
&Compliance
Medivation Inc
San Francisco, CA, United States
[email protected]
Diane Fassbender
Project Manager, Pharmacovigilance
United BioSource Corp
Blue Bell, PA, United States
[email protected]
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
[email protected]
Diane Marks
Associate Director, RA
Adaptimmune
Philadelphia, PA, United States
[email protected]
Diane Nell
CSO
FDA
Silver Spring, MD, United States
[email protected]
Diane Tarapata
International Regulatory Associate
Church & Dwight Co Inc.
Princeton, NJ, United States
[email protected]
Dianne Schuetz
SVP, Operations
Force Diagnostics, Inc.
Bannockburn, IL, United States
[email protected]
Dilip Parikh
President
DPHARMA GROUP INC.
ELLICOTT CITY, MD, United States
[email protected]
Dimple Bommanaboina
Regulatory
Citron Pharma
East Brunswick, NJ, United States
[email protected]
Dinesh Anugu
Regulatory Affairs Associate
Insys Therapeutics
Chandler, AZ, United States
[email protected]
Donald Johnson
Vice President
Pharmaceutics International, Inc.
Hunt Valley, MD, United States
[email protected]
Donna Coppenhaver
Manager, Regulatory Affairs & Compliance
WellSpring Pharmaceuitcal Corporation
Sarasota, FL, United States
[email protected]
Dnyaneshwar Gawade
Manager -Training & Development
Sun Pharmaceutical Industries Ltd
Industrial Area III, AB Road, Dewas,
Madhya Pradesh (India) – 455001, Non-US,
India
Donna
Djinovich
[email protected]
regulatory director
rauland
mount prospect, IL, United States
[email protected]
Donna Headlee
C sO
FDA
Silver spring, MD, United States
[email protected]
Donna Headlee
Consumer Safety Officer
FDA
Silver Spring, MD, United States
[email protected]
Donna Pyne
Software QA
Neuronetics Inc
Malvern, PA, United States
[email protected]
Donna Sade
Regulatory Representative
Eastman Chemical Company
Kingsport, TN, United States
[email protected]
Dorit Winitz
VP Regulatory and Clinical Affairs
Medial Cancer Screening Ltd
Kfar Malal, Non-US, Israel
[email protected]
Douglas Bueschel
Vice President of Quality Assurance
Rapid Pathogen Screening
Sarasota, FL, United States
[email protected]
Douglas Dumont
AIMBE Scholar
AIMBE
White Oak, MD, United States
[email protected]
Dov Gal
VP RA QA CA
ClearFlow
Anaheim, CA, United States
[email protected]
Dr Rakesh Sonawane
Resident Doctor
Gandhi Medical College,Bhopal
Bhopal, MA, India
[email protected]
Dr.Gandham Shanthi Kumar
hospital management
flourissh slimming & cosmewtic wellbing
center
hyderabad, Non-US, India
[email protected]
Dustin Rush
Production Manager
IONflow
Marina Del Rey, CA, United States
[email protected]
Drew Jackl
VP
Custom Assemblies
Pine Level, NC, United States
[email protected]
Drugaprasad Erukulla
Regulatory Affairs
Mylan laboratories Limited
Hyderabad, Non-US, India
[email protected]
Dylan Alu
Regulatory Coordinator
Drucker Diagnostics
Philipsburg, PA, United States
[email protected]
E Mitchell Seymour
Regulatory Project Manager
University of Michigan
Ann Arbor, MI, United States
[email protected]
Earleen Parks
Regulatory Affairs Manager
Remel Inc. (part of Thermo Fisher
Scientific)
Lenexa, KS, United States
[email protected]
Eberth Sarmiento Infantes
EVALUATOR
MINISTERIO DE SALUD
LIMA, Non-US, Peru
[email protected]
Edmond Gosda
Consultant
Validant
Clark, NJ, United States
[email protected]
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
[email protected]
Eduard Benetskiy
Project Manager
OncoTartis LLC
Moscow, Non-US, Russian Federation
[email protected]
Edzel Escala
Quality Manager
Garaventa Canada Ltd.
Surrey, Non-US, Canada
[email protected]
Efrem Borga
QA MANAGER
On-X LTI
AUSTIN, TX, United States
[email protected]
Eileen Daloia
Director Regulatory Affairs
Crown Laboratories
Johnson City, TN, United States
[email protected]
Elad Fein
Ceo
iFeel Labs
nofit, Non-US, Israel
[email protected]
Elaine Berry
Sr. Regulatory Scientist
The Emmes Corporation
Rockville, MD, United States
[email protected]
Eimy Araque
Pharmacist I
Instituto Nacional de Higiene "Rafael
Rangel"
Caracas, Non-US, Venezuela
[email protected]
Eleanor Panico
Regulatory Consultant
Innovative Science Solutions
Jersey City, NJ, United States
[email protected]
Eleanore Dias
Regulatory Affairs Specialist
Mortara Instrument
Milwaukee, WI, United States
el[email protected]
Elena Renaud
Sr. Maneger Reg. Affairs
Insys Theurapeutics
Chander, AZ, United States
[email protected]
Elijah Wreh
Regulatory Affairs Manager (Pre-Market)
Invacare Corporation
Elyria, OH, United States
[email protected]
Elizabeth Brock
Quality Systems Manager
MEDTOX Diagnostics, Inc.
Burlington, NC, United States
[email protected]
Elias Mallis
Director, Division of Industry and
Consumer Education
U.S. Food and Drug Administration
Silver Spring, MD, United States
[email protected]
Elizabeth Leffel
President
Leffel Consulting Group, LLC
Berryville, VA, United States
[email protected]
Elizabeth Mason
Manager, Regulatory Affairs
Haemonetics Corporation
Covina, CA, United States
[email protected]
Elizabeth Noble
Owner
Elizabeth P. Noble,Inc.
Salisbury, NC, United States
[email protected]
Elizabeth Ottinger
Senior Project Manager
NIH/NCATS
Rockville, MD, United States
[email protected]
Elizabeth Ripley
Clinical Research Compliance Officer
Virginia Commonwealth University
Richmond, VA, United States
[email protected]
Elizabeth Rosenkrands-Lange
Manager
LEO Pharma Inc.
Parsippany, NJ, United States
[email protected]
Elizabeth Sherman
Manager of QA and Regulatory
Bell International Laboratories
Minneapolis, MN, United States
[email protected]
Elizabeth Rosenkrands-Lange
Manager
LEO Pharma Inc.
Parsippany, NJ, United States
[email protected]
Ellen Camos
Director, Regulatory Affairs
ANI Pharmaceuticals
Baudette, MN, United States
[email protected]
Eman Ayyub
CEO
JiA pharma international
Stoneham, MA, United States
[email protected]
Emily Morris
Clinical and Regulatory Associate
Medicines360
San Francisco, CA, United States
[email protected]
Emily Vanhassel
Associate Director of Regulatory Affairs
Tetraphase Pharmaceuticals, Inc.
Watertown, MA, United States
[email protected]
Erez Hazan
QA
sion biotext
HAgosrim, Non-US, Israel
[email protected]
Eric Drupals
Clinical Research Consultant
Medcon Consulting
BEACONSFIELD, Non-US, Canada
[email protected]
Eric Joseph
Assc Director, Regulatory Affairs
Chattem
Chattanooga, TN, United States
[email protected]
Elvia Gustavson
Senior Regulatory Affairs Consultant
Jeff Yuen & Associates
San Juan Capistrano, CA, United States
[email protected]
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
[email protected]
Eric Song
quality director
sagent china pharmaceuticals
chengdu, Non-US, China
[email protected]
Erica Kontson
Product Engineer
Little Sparrows Technologies
Boston, MA, United States
[email protected]
Erica Nicoll
Regulatory Compliance Specialist
Novum Pharmaceutical Research Services
Pittsburgh, PA, United States
[email protected]
Erica Wright
Engineer
InGeneron
Houston, TX, United States
[email protected]
Erika Crowley
QS Compliance Analyst
Fresinius Medical Care
Waltham, MA, United States
[email protected]
Erin Mcfiren
Investigator
FDA
Baltimore, MD, United States
[email protected]
Erin Quencer
Regulatory Analyst
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Ettore Amato
M.Sc.
University of Milan
Milan, Non-US, Italy
[email protected]
Eugene Borrelli
Quality Assurance Specialist
IBA Molecular
Sterling, VA, United States
[email protected]
Eva Chin
CSO
MyoTherapeutics
Silver Spring, MD, United States
[email protected]
Evan Maddocks
Quality Manager
Advanced Instruments, Inc
Norwood, MA, United States
[email protected]
Ewa Kaczanowska
Regulatory Manager
BTE Technologies, Inc.
Hanover, MD, United States
[email protected]
Faisal Abbas
Quality Assurance Manager
Tabros Pharma
karachi, Non-US, Pakistan
[email protected]
Faiz Ullah Khan
R&D
PharmEvo.Pvt.Ltd
Karachi, PA, Pakistan
[email protected]
Farhan Ayub
Asst. Manager Validation
Genix Pharma (pvt.) Ltd.
Karachi, Non-US, Pakistan
[email protected]
Felix Morales
Quality Assurance Manager
Navajo Manufacturing Company Inc.
Denver, CO, United States
[email protected]
Florence Nacino
CEO
V Manufacturing & Logistics Inc.
Walnut, CA, United States
[email protected]
Fathima Javeed
Manager of Regulatory Operation and
Quality Control
Cerecor Inc.
Baltimore, MD, United States
[email protected]
Flor Del Pilar Arana Sanchez
Senior Director Regulatory Affairs &
Compliance
KLOX Technologies Inc
Montreal, Non-US, Canada
[email protected]
Forest Ford
CSO
FDA
Silver Spring, MD, United States
[email protected]
Frank Mondoro
Director, Quality & Compliance
JLL
Kenilworth, NJ, United States
[email protected]
Fred Defesche
President
RegCon Solutions LLC
San Diego, CA, United States
[email protected]
Fred Mcbee
President
Focus Health Group
Knoxville, TN, United States
[email protected]
Fred Weiss
Vice President of Quality
IGI Labs, Inc.
Buena, NJ, United States
[email protected]
Frederick Golec
president
CMCRegAff LLC
merion station, PA, United States
[email protected]
Frida Grynspan
nager
Stem Cell Medicine Ltd
jerusalem, Non-US, Israel
[email protected]
Fernando Sanchez
Sr. Compliance Auditor
Johnson & Johnson
Irvine, CA, United States
[email protected]
Flora Gilde
validation engineer
TORNIER
Montbonnot, Non-US, France
[email protected]
Francisco Franco
President
Dentimed Sao Joao LLC
Sunrise, FL, United States
[email protected]
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
[email protected]
Gaetano Rizzo
Manager, QA and Regulatory
iuvo BioScience
Rush, NY, United States
[email protected]
Ganga Kolli
Sr.Regulatory Affairs Specialist
USEndoscopy
Mentor, OH, United States
[email protected]
Geanie Umberger
Associate Dean for Engagement and
Clinical Professor
Purdue University
West Lafayette, IL, United States
[email protected]
Geetha Jayan
SSHA
CDRH/FDA
White Oak, MD, United States
[email protected]
Geeta Routray
Manager
Piramal Enterprises Limited
Mumbai, Non-US, India
[email protected]
Geetaram Sahu
Research Scientist
George Washington University
Washington, DC, United States
[email protected]
Gene Kulon
Quality Manager
Golden Technologies, Inc
Old Forge, PA, United States
[email protected]
Genoa Atwood
Quality
Span Packaging Services
Greenville, SC, United States
[email protected]
George Chaux
Engineer
Captiva Spine
Jupiter, FL, United States
[email protected]
George Hellman
self-employed
none
San Diego, CA, United States
[email protected]
George Plopper
Lead Associate, Regulatory Science
Booz Allen Hamilton
Rockville, MD, United States
[email protected]
Gerald Collins
CEO
Treadwell Corporation
Wilmington, NC, United States
[email protected]
Gerardo Mendoza
Chromatography Analyst
Pisa Farmaceutica
Tlajomulco de Zuñiga, Non-US, Mexico
[email protected]
Gillian Miller
Snr Regulatory Scientist
Emmes
Rockville, MD, United States
[email protected]
Gina Rivera
Quality Managment System
MEDICA D
Mexico City, Non-US, Mexico
[email protected]
Giorgio Bonmassar
Ass Professor
MGH
Charlestown, MA, United States
[email protected]
Giridhar Prasad Jangly
Regulatory Associate
Dr. Reddy's Laboratories Inc.
Princeton, NJ, United States
[email protected]
Girish Koni
Scientist/Chemist
Guardian Drug Company
Dayton, NJ, United States
[email protected]
Gladys Martin
Regulatory Affairs Manager
Romark Laboratories, L.C.
Tampa, FL, United States
[email protected]
Gloria Ferko
Consultant, Quality & Regulatory
Gloria Ferko, QA/RA Consultant
Palmerton, PA, United States
[email protected]
Golnaz Moeini
Sr. Regulatory Affairs Analyst
Stryker
San Jose, CA, United States
[email protected]
Gopal Patel
Regulatory Affairs Specialist
Navinta LLC
Ewing, NJ, United States
[email protected]
Gopinath. N Nallusamy
Scientist
Par Formulations Pvt Ltd
Chennai, Non-US, India
[email protected]
Gordon Willins
Quality Manager
EPIC Technologies
Mason, OH, United States
[email protected]
Grace Suh
Regulatory Specialist
Passy-Muir
Irvine, CA, United States
[email protected]
Graciela Salazar Vargas
Specialist
Goverment
San Jose, Non-US, Costa Rica
[email protected]
Greg Burkholder
CEO
Transitions Industries
Lubbock, TX, United States
[email protected]
Greg Freeman
Senior Engineer
Good Automation, LLC
Irving, TX, United States
[email protected]
Greg Freeman
Senior Engineer
Good Automation, LLC
Irving, TX, United States
[email protected]
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
[email protected]
Gregg Ritter
Regulatory Affairs Specialist
Acumed
Hillsboro, OR, United States
[email protected]
Gregor Dzialas
Director Regulatory Affairs
NxStage Medical, Inc.
Lawrence, MA, United States
[email protected]
Gregory Happe
Quality Assurance Specialst I
Maine Standards Company
Cumberland Foreside, ME, United States
[email protected]
Guangyu Luo
Senior RA Associate
Prinston Pharmaceutical Inc.
Cranbury, NJ, United States
[email protected]
Hana Boudiaf
Regulatory affairs specialist
Medincell
Jacou, Non-US, France
[email protected]
Hannah Le
Student
Purdue
West lafayette, IN, United States
[email protected]
Hannah Rafols
Document Coordinator
Chiesi USA, Inc.
Cary, NC, United States
[email protected]
Hanne Nielsen
Regulatory Affairs Manager
3shape A/S
Copenhagen, Non-US, Denmark
[email protected]
Hardik Gohil
Intern
Aavis pharmacuticals
Atlanta, GA, United States
[email protected]
Harel Halevi
CEO
Nefield Diagnostics
Tel Aviv, Non-US, Israel
[email protected]
Harendra Chauhan
Regulatory Project Manager
Sun Pharmaceutical
Gurgaon, Non-US, India
[email protected]
Harikishan Komma
Head-Regulatory Affairs
Caplin Point Laboratories Limited
Chennai, Non-US, India
[email protected]
Harikishan Komma
Head - Regulatory Affairs
Caplin Point Laboratories Limited
Chennai, Non-US, India
[email protected]
Harlow Thielke
Regulatory Affairs Coordinator
Starkey Hearing Technologies
Eden Prairie, MN, United States
[email protected]
Harriet Kamendi
Director
Kandih Group
Silver Spring, MD, United States
[email protected]
Hasmukh Patel
Acting Director
FDA
Silver Spring, MD, United States
[email protected]
Hasnat Dastgir
Production Manager
Standpharm Pakistan (Pvt.) Ltd.
Lahore, Non-US, Pakistan
[email protected]
Heather Bryant
Quality Assurance Specialist II
Maine Standards Company
Cumberland Foreside, ME, United States
[email protected]
Heather Erdman
CSO
FDA/CBER
Silver Spring, MD, United States
[email protected]
Heather Gingerich
Regulatory Affairs Associate
Sun Pharmaceutical Industries, Inc.
Bryan, OH, United States
[email protected]
Heather Lambert
Regulatory Administrator
Investigative Clinical Research of Indiana,
LLC
Indianapolis, IN, United States
[email protected]
Helen Sun
Associate Director, Regulatory Affairs
Valeant Pharmaceuticals
Bridgewater, NJ, United States
[email protected]
Helen Hu
VP QA
wilmington pharmatech
Newark, DE, United States
[email protected]
Helen Lewis
Corporate Regulatory Affairs Director
Dentsply International
York, PA, United States
[email protected]
Helen Zhou
Senior Associate Director
Bristol-Myers Squibb
Princeton, NJ, United States
[email protected]
Henry Eran
Director Quality Control
C3 Jian
Marina del Rey, CA, United States
[email protected]
Heran Jang
Qualitay Assurance Manager
Nano-Ditech Corporation
Cranbury, NJ, United States
[email protected]
Hetal Shah
CEO
Arizona Women's Specialists
phoenix, AZ, United States
[email protected]
Hilda Grabczewski
Regulatory Specialist
National Cancer Institute
Rockville, MD, United States
[email protected]
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
[email protected]
Himanshu Jain
QA Manager, Product Development
Contract Pharmaceuticals Limlted
Mississauga, Non-US, Canada
[email protected]
Hippolitus Odukwu
Director, QA & Regulatory Affairs
Angelini Pharma Inc.
Gaithersburg, MD, United States
[email protected]
Hitesh Bhagat
President
AP Medesthetics, Inc.
Wayland, MA, United States
[email protected]
Holli Vaughan
Regulatory Project Manager
Biologics Consulting Group, Inc.
Alexandria, VA, United States
[email protected]
Hollie Johnson
Quality/Regulatory Manager
Swissray International
Piscataway, NJ, United States
[email protected]
Holly Opdyke
Regulatory Compliance Analyst
J. Knipper & Company
Lakewood, NJ, United States
[email protected]
Hua Deng
president
davidia healthtech
san diego, CA, United States
[email protected]
Hui Tang
President
Innervo Technology LLC
Columbia, MO, United States
[email protected]
Humaira Siddique
Head of Quality Assurance
Highnoon laboratories
Lahore, Non-US, Pakistan
[email protected]
Huy Truong
associate director
Johnson & Johnson
raritan, NJ, United States
[email protected]
Iacovos Kyprianou
Senior Science Health Advisor
US FDA
Silver Spring, MD, United States
[email protected]
Ihsan Haddad
President
Anesthesia Safety Products, LLC
Woburn, MA, United States
[email protected]
Ilana Fogelman
Chief Operating Officer
LifeTech Research
Washington, DC, United States
[email protected]
Imtiyaz Ubharay
Manage R&D-QA
Tris Pharma Inc.
Monmouth Junction, NJ, United States
[email protected]
Ipsa Patel
Regulatory Affairs Associate
Aveva Drug Delivery Systems, Inc
Miramar, FL, United States
[email protected]
Isabel Cisneros
Regulatory Affairs
RGR Pharma Ltd.
LaSalle, Non-US, Canada
[email protected]
Isabelle Morin
Compliance Specialist
Delta Pharma inc.
Montréal, Non-US, Canada
[email protected]
Israel Citron
VP QA/RA
Aspect Imaging LTD
Shoham, Non-US, Israel
[email protected]
Ivan Stangel
Scientific Director
BioMat Sciences
Bethesda, MD, United States
[email protected]
Ivy Bautista
Assoc. Director RA
Ferring Pharmaceuticals Inc
Parsippany, NJ, United States
[email protected]
Izumi Clifford
Regulatory and Quality Supervisor
Shimadzu Scientific Instruments
columbia, MD, United States
[email protected]
Jace Kelley
Engineer
MED Institute, Inc.
West Lafayette, IN, United States
[email protected]
Jack Kent
Director of Regulatory Affairs
Clear Guide Medical
Baltimore, MD, United States
[email protected]
Jackie Lafollette
VP Regulatory
Chase Medical
Richardson, TX, United States
[email protected]
Jaclyn Collins
Quality Assurance Manager
Medical Technologies of Georgia, Inc
Covington, GA, United States
[email protected]
Jacqlyn Riposo
Regulatory Specialist
AABB
Bethesda, MD, United States
[email protected]
Jagadeesha V P
Group Head
WIPRO LIMITED
Bangalore, Non-US, India
[email protected]
Jaime Casas
International Sales Director
American Non-stop Label
Los Angeles, CA, United States
[email protected]
Jaime Lee
Regulatory Affairs Associate
Terumo Cardiovascular Systems
Elkton, MD, United States
[email protected]
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
[email protected]
James Champlin
Manager, Qa & RA
Maine Standards Company
Cumberland Foreside, ME, United States
[email protected]
James Gill
Quality Manager
Gorbel Medical
Fishers, NY, United States
[email protected]
James Juul
Vice President
Curatek Pharmaceuticals LLC
Elk Grove Village, IL, United States
[email protected]
James Mayol
Director, QA & Regulatory Compliance
Augmenix, Inc.
Waltham, MA, United States
[email protected]
James Rogers
President
Coastal Consulting Group
Pittsburgh, PA, United States
[email protected]
James Vogan
Quality Systems Auditor
Fresenius Medical Care
Waltham, MA, United States
[email protected]
Jami Miller
Regulatory Director
Medallion Therapeutics
Santa Clarita, CA, United States
[email protected]
Jamie Brugnano
Research Scientist
Organovo
San Diego, CA, United States
[email protected]
Jan Miller
Research Coordinator, RN
Gwinnett Medical Center
Lawrenceville, GA, United States
jmill[email protected]
Jan Triani
QA/RA
EDGE Orthopaedics
Boonton, NJ, United States
[email protected]
Jane Cook
Regulatory Affairs Scientist
USAMMDA
Frederick, MD, United States
[email protected]
Jane Stachura
VP, Regulatory Affairs, CMC
Marathon Pharmaceuticals, LLC
Northbrook, IL, United States
[email protected]
Janet Bukovcan
Senior Manager, Regulatory Affairs
BTG
Ottawa, Non-US, Canada
[email protected]
Jared Mcdonley
Compliance Manager
OneBlood
Fort Lauderdale, FL, United States
[email protected]
Jason Hartnett
QA/RA Mgr.
Lab Crafters, Inc.
Ronkonkoma, NY, United States
[email protected]
Javeriya Ansari
Business Development Executive
Pharma
Karachi, Non-US, Pakistan
[email protected]
Javorka Gunic
QA Manager
Evofem
San Diego, CA, United States
[email protected]
Jay Trivedi
Director
Patrin Pharma
Skokie, IL, United States
[email protected]
Jaya Dhiman
Sr. Executive CQA
Sentiss Pharma
Gurgaon, IN, India
[email protected]
Jayesh Rajgopal
Resident
GANDHI MEDICAL COLLEGE, BHOPAL
BHOPAL, Non-US, India
[email protected]
Jean Pak
Director, Regulatory and Clinical Affairs
OPHTEC USA, Inc.
Boca Raton, FL, United States
[email protected]
Jeannine Ramsey
Consultant
Accurate Clinical Solutions
Wellington, OH, United States
[email protected]
Jeevan Kumar Kunuku
Sr. Officer
Gland Pharma Limited
Hyderabad, Non-US, India
[email protected]
Jeff Cline
Prin SQE
R&Q Solutions
Jacksonville, OH, United States
[email protected]
Jeff Cline
SQE
R&Q Solution
Cleveland, OH, United States
[email protected]
Jeff Yao
Regulatory Affairs Manager
Sunny Pharmtech Inc.
New Taipei City, Non-US, Taiwan
[email protected]
Jeffrey Cooper
Supervisory Health Scientist
FDA
Silver Spring, MD, United States
[email protected]
Jeffrey Hausfeld Md, Mba
Chairman of the Board
BioFactura
Frederick, MD, United States
[email protected]
Jenee Bevett
Reg Affairs Specialist/Technical Coord.
Social & Scientific Systems, Inc.
Silver Spring, MD, United States
[email protected]
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
[email protected]
Jeness Jose
Regulatory Affairs
Sandoz
Trenton, NJ, United States
[email protected]
Jennifer Innamorato
Quality Engineer
Perryman
Houston, PA, United States
[email protected]
Jennifer Sunshine
Lead Associate
Booz Allen Hamilton
Washington, DC, United States
[email protected]
Jennifer Timmerman
Director of Regulatory Affairs
Kedrion Biopharma
Fort Lee, NJ, United States
[email protected]
Jenny Li
Staff Scientist
Noramco
Wilmington, DE, United States
[email protected]
Jenny Zhang
Chief Scientist
Andersen Sterilizers
Haw River, NC, United States
[email protected]
Jenny Zong
Regulatory Specialist
Reach Surgical,Inc
Tianjin, Non-US, China
[email protected]
Jeremy Richardson
Complaint Coordinator
Telcare Medical Supply
Concord, MA, United States
[email protected]
Jessica Clemmons
Quality Engineer
YSI, Inc.
Yellow Springs, OH, United States
[email protected]
Jessica Heckrote
Sr. Quality Technician
Oakworks
New Freedom, PA, United States
[email protected]
Jessica Kelley
Product Manager
EMC
Princeton, NJ, United States
[email protected]
Jessica Kokosinski
Assistant Vice President
Genpact Pharmalink
Baltimore, MD, United States
[email protected]
Jessica Montejo
Sr. RA Specialist
Medline
Mundelein, IL, United States
[email protected]
Jessica Ralyn
Senior Manager, Quality
Exact Sciences
Madison, WI, United States
[email protected]
Jessica Swanson
Senior Regulatory Affairs Specialist
LifeCell Corporation
Bridgewater, NJ, United States
[email protected]
Jibran Khan
Assistant Manager Regulatory Affairs
SEARLE
Karachi, SC, Pakistan
[email protected]
Jihyeon Kim
Project Assistant
KCRN Research
Germantown, MD, United States
[email protected]
Jingran Lu
RA Speclist
Prinston Pharmacutical Inc.
cranbury, NJ, United States
[email protected]
Jinous Saeedi
Manager Compliance Quality System
IRVINE SCIENTIFIC
Irvine, CA, United States
[email protected]
Jismi Johnson
Regulatory Advisor
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Jo Collins
Manager, Quality Clinical Compliance
Ora, Inc.
Andover, MA, United States
[email protected]
Joan Cheng
QA & RA Manager
NovoDiax
Hayward, CA, United States
[email protected]
Joan Cheng
Director
GQM
Oakland, CA, United States
[email protected]
Joan Fanis
QA Manager Sterile Forms
Rafarm S.A.
Athens, Non-US, Greece
[email protected]
Joan Tomczyk
QA/RA Assistant Manager
Hiossen Inc
Fairless Hills, PA, United States
[email protected]
Joann Brumbaugh
Nurse Consultant
FDA
Silver Spring, MD, United States
[email protected]
Joann Pittman
Public Affairs Specialist
Food and Drug Administration
Atlanta, GA, United States
[email protected]
Joanne Marriott
SVP
Amerigen Pharmaceuticals Inc
Lyndhurst, NJ, United States
[email protected]
Joe Murphy
Director, Combination Products Compliance
Janssen
Neuchatel, Non-US, Switzerland
[email protected]
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
[email protected]
John Gill
Clinical Manager
St. Jude Medical
Sylmar, CA, United States
[email protected]
John Gorney
Quality Manager
Signal Medical Corporation
Marysville, MI, United States
[email protected]
John Huang
Consumer Safety Officer
FDA
Silver Spring, MD, United States
[email protected]
John Huff
Director, Risk Management
AtriCure Inc.
West Chester, OH, United States
[email protected]
John Maddalena
Quality Director
Haemtech Biopharma Services
Essex Junction, VT, United States
[email protected]
John Mundi
Product Information Officer
Health Canada
Ottawa, Non-US, Canada
[email protected]
John Oberholtzer
Senior Regulatory Affairs Manager
Celerity Pharmaceuticals, LLC
Rosemont, IL, United States
[email protected]
John Ruiz
Staff Fellow
FDA-CDRH
White Oak, MD, United States
[email protected]
John Zehner
Executive Vice President and COO
Global Isotopes/Zevacor Molecular
Noblesville, IN, United States
[email protected]
Jonas Kazmirczak
Analyst
Prati Donaduzzzi
Toledo, Non-US, Brazil
[email protected]
Jonghyeon Kim
Sr Manager Biostatistics
Otsuka
Rockville, MD, United States
[email protected]
Jorge Castanos
President
Quality and Regulatory Compliance Corp.
Gurnee, IL, United States
[email protected]
Jose Centeno
Division Director, DBCMS
U.S. FDA - CDRH - OSEL
Silver Spring, MD, United States
[email protected]
Joseph Hillring
Regulatory Affairs Associate
Hillring & Associates Inc.
Tampa, FL, United States
[email protected]
Joseph Tartal
Branch Chief
Food and Drug Administration
Silver Spring, MD, United States
[email protected]
Joy Frestedt
President and CEO
Frestedt Inc.
Saint Louis Park, MN, United States
[email protected]
Joyce Dean
Regulatory Compliance Manager
Universal Medical, Inc.
Ewing, NJ, United States
[email protected]
Juan Zong
Regulatory Affairs Executive
Reach Surgical, Inc
Tianjin, Non-US, China
[email protected]
Judith Cohen
Director QA
Particle Sciences Inc
Bethlehem, PA, United States
[email protected]
Judy Costello
Acting Executive Director
BioMaryland
Baltimore, MD, United States
[email protected]
Judy Snow
VP, QA/RA
Keller Medical
Stuart, FL, United States
[email protected]
Julia Choi
Quality Engineer - Risk Management
Intuitive Surgical
Sunnyvale, CA, United States
[email protected]
Julia Lynne
Project Manager
The Emmes Corporation
Rockville, MD, United States
[email protected]
Julie Anne Zawisza
Associate Director for External Relations
FDA
Silver Spring, MD, United States
[email protected]
Julie Koch
Interim Director of Cancer Research
MacNeal Hospital
Berwyn, IL, United States
[email protected]
Julienne Pearson
Associate
Teva Pharmaceuticals
Woodcliff Lake, NJ, United States
[email protected]
Julieta Catania
Quality Manager
TECME
Córdoba, AR, Argentina
[email protected]
Julio Lin
assistant Vice President
Fish
Taipei, Non-US, Taiwan
[email protected]
Julio Rivera
Directo of Compliance Initiatives
Regulatory and Quality Solutions LLC
Pittsburgh, PA, United States
[email protected]
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
[email protected]
Junle Ren
Senior Researcher
Yiling Pharmaceutical Ltd
Shijiazhuang, Non-US, China
[email protected]
Justin Metcalf
Engineering manager
Med institute
West Lafayette, IN, United States
[email protected]
Justin Uthup
Manager, Regulatory Affairs
ANI Pharmaceuticals, Inc.
Baudette, MN, United States
[email protected]
Kalyani Tammareddy
QUALITY SYSTEMS MANAGER
JOHNS HOPKINS UNIVERSITY
BALTIMORE, MD, United States
[email protected]
Kamal Negi
Corporate Quality Assurance
Sentiss
Faridabad, Non-US, India
[email protected]
Kamarthi Murali
Deputy Manager
Biocon
Bangalore, IN, India
[email protected]
Kandarp Shah
Regulatory Affairs Administrator
STAAR Surgical Company
Monrovia, CA, United States
[email protected]
Kapil Dev
Manager - Regulatory Affairs
Titenare GXL
Bengaluru, Non-US, India
[email protected]
Karen D. Orr
CEO, Founder
OhZ, LLC
Madison, WI, United States
[email protected]
Karen Denny
Regulatory Affairs Specialist
Becton Dickinson Diagnostics
Durham, NC, United States
[email protected]
Karen Houseton
QA/RA Consultant
MAK and Associates
Dousman, WI, United States
[email protected]
Karen Kim
Regulatory Manager
Stocosil Inc.
City of Industry, CA, United States
[email protected]
Karen Metcalfe
Director, Rgulatory Affairs
DVC
Frederick, MD, United States
[email protected]
Karen Otoole
Manager, Global Regulatory Affairs
Rapid Pathogen Screening Inc
Sarasota, FL, United States
[email protected]
Karen Smith
Dir of Reg Compliance
BD
Franklin Lakes, NJ, United States
[email protected]
Karen Veltri
Oncology Drug Reviewer
Health Canada
Ottawa, Non-US, Canada
[email protected]
Karen Zimm
Associate Director
J&J
Titusville, NJ, United States
[email protected]
Karl Muehlheuser
Associate
Contubernium Worldwide, Inc.
Washington, DC, United States
[email protected]
Karl Scott
Sr. Manager, Compliance
Johnson & Johnson
Raritan, NJ, United States
[email protected]
Karl Zhou
medical director
Kintor
Bridgewater, NJ, United States
[email protected]
Kartick Das
Manager, Audit & Assurance
GSK Bangladesh Ltd
Chittagong, Non-US, Bangladesh
[email protected]
Kassa Ayalew
Branch Chief
FDA/CDER/OSI
Silver Spring, MD, United States
[email protected]
Katarzyna Mielniczuk
Regulatory Affairs
R4M
Jarosław, Non-US, Poland
[email protected]
Katharina Kurpanek
Managing Director
The QM Company
Brussels, Non-US, Belgium
[email protected]
Katarina Ilic
Executive Director, Global
Pharmacovigiulance and Drug Safety
Raptor Pharmaceuticals
NOVATO, CA, United States
[email protected]
Katherine Groff
Research Associate
PETA International Science Consortium
Norfolk, VA, United States
[email protected]
Katherine Timashpolsky
Clinical Research Associate
St. Jude Medical, Inc.
Sylmar, CA, United States
[email protected]
Kathleen Hewitt
Project Manager
Biologics Consulting Group
Alexandria, VA, United States
[email protected]
Kathryn Widman
Sr. Consultant
Booz Allen Hamilton
Arlington, VA, United States
[email protected]
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
[email protected]
Kathy Mancl
CCRP
Marshfield Clinic
Marshfield, WI, United States
[email protected]
Katie Jackson
Manager
Avalere Health
Washington, DC, United States
[email protected]
Kavonna Allen
Regulatory Affairs Associate I
Facet Technologies, LLC
Atlanta, GA, United States
[email protected]
Kazuyuki Atarashi
Global Program Manager
MBL International
Woburn, MA, United States
[email protected]
Kelley Boyer
Manager, Regulatory Operations
SciLucent
Herndon, VA, United States
[email protected]
Kellie Kennon
Sr. Director Clinical Research
Asklepion Pharmaceuticals, LLC
Baltimore, MD, United States
[email protected]
Kelly Evers
Sr QA Specialist
ISTO Technologies, Inc.
St. Louis, MO, United States
[email protected]
Kelly Holmes-Smith
Engineer
DOD
Washington, DC, United States
[email protected]
Kelly Key
Quality Operations Manager
Endo Pharmaceuticals
Huntsville, AL, United States
[email protected]
Kelly Reich
Regulatory Project Manager
Biologics Consulting Group, Inc.
Alexandria, VA, United States
[email protected]
Kelly Scuderi
Regulatory Technical Specialist
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA, United States
[email protected]
Kelly Wilkicki
Senior Advisor
FDA
Silver Spring, MD, United States
[email protected]
Kelsey Lawfer
Visiting Scientist Fellow
Eli Lilly and Company
Indianapolis, IN, United States
[email protected]
Ken Myers
Dir. Global Product Regulatory Affairs
Nu Skin Enterprises
Provo, UT, United States
[email protected]
Kenneth Jablonicky
QA/Reg Director
Graphic Controls
Buffalo, NY, United States
[email protected]
Kenny Struwig
MARCOM Manager
Sion Biotex Medical Ltd.
Hagoshrim, Non-US, Israel
[email protected]
Kerry Armstrong
Director, Compliance
Picis Clinical Solutions, Inc.
Wakefield, MA, United States
[email protected]
Kervain Cao
QA
DANYANG JUMAO
DANYANG, Non-US, China
[email protected]
Kevin Daly
Principal
Kevin Daly Consulting, LLC
Encinitas, CA, United States
[email protected]
Kevin Murrock
Principal Consultant
QR Medical Consulting
Twinsburg, OH, United States
[email protected]
Kevin Norman
Principle Owner
NKI BIOPHARMACEUTICALS, LLC
King of Prussia, PA, United States
[email protected]
Kevin Olcott
Director of Technical Operations
Anutra Medical
Morrisville, NC, United States
[email protected]
Khalil Dahdouh
International Director
Medi Express Inc
Garfield, NJ, United States
[email protected]
Khaudeja Bano
Sr. Med Dir / Head of Medical device
Safety
AbbVie Inc
Chicago, IL, United States
[email protected]
Ki Kim
Project Assistant
KCRN Research
Boyds, MD, United States
[email protected]
Khemraj Hirani
Director, Regulatory Affairs and QA
University of Miami Miller School of
Medicine
Miami, FL, United States
[email protected]
Kim Life
Attorney
Life Law
Lakeside, CA, United States
[email protected]
Khurram Khan
RA Manager
Blu Pharmaceuticals
Franklin, KY, United States
[email protected]
Kim Schiltz
Study Coordinator
University of Iowa Hospitals & Clinics
Iowa City, IA, United States
[email protected]
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
[email protected]
Kimberly Grevera
Regukatory Affairs Manager
GeNO LLC
Cocoa, FL, United States
[email protected]
Kimberly Light
Director of Regulatory Affairs
BioPro
Port Huron, MI, United States
[email protected]
Kimberly Patterson
Assoc. Director
WES Pharma Inc.
Westmister, MD, United States
[email protected]
Kimberly Piermatteo
Engineer
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Kiran Singh
Associate Director
Sandoz Inc.
Princeton, NJ, United States
[email protected]
Kishore Addanki
Assistant Manager
Mylan Laboratories Limited
Hyderabad, Non-US, India
[email protected]
Komila Fayzieva
Assistant Administrator
Pharmaceutics International Inc
Hunt Valley, MD, United States
[email protected]
Kory Hallett
Health Science Policy Analyst
National Cancer Institute
Bethesda, MD, United States
[email protected]
Krasi Pekova
Pharmacist
Northeastern University
Boston, MA, United States
[email protected]
Kris Faria
Sr Mgr Regulatory Ops/RA Assoc
KaloBios
South San Francisco, CA, United States
[email protected]
Kristin Benokraitis
Director of Quality and Operations
EG-GILERO
Durham, NC, United States
[email protected]
Kristin Henney
Associate Director
Baxter Healthcare
Round Lake, IL, United States
[email protected]
Krupal Rewanwar
Sr. RA Specialist
ORS
Itasca, IL, United States
[email protected]
Kyu-Pyo Kim
Assistant Professor
Asan Medical Center
Seoul, Non-US, South Korea
[email protected]
L Meghana Pamidighantam
Quality Assurance Manager
AnshLabs
Webster, TX, United States
[email protected]
Lacey Holman
Regulatory Affairs Project Manager
Mallinckrodt Pharmaceuticals
Hazelwood, MO, United States
[email protected]
Lakeshia Stitt
Sr. Compliance Specialist
Pharmaceutical Associates, Inc
greenville, SC, United States
[email protected]
Lakshmi Kodeboyina
Consultant
Invigo soft
Irving, TX, United States
[email protected]
Larissa Mitchell
Research Compliance Coordinator
Upstate Cardiology
Greenville, SC, United States
[email protected]
Lars Lafferty
Sales Consultant
Private
Syosset, NY, United States
[email protected]
La-Shaunda Joseph
Regulatory Affairs
Rochem International, Inc.
Hauppauge, NY, United States
[email protected]
Laura Boll
Vice President Quality and Regulatory
Affairs
Medovations
Medovations, WI, United States
[email protected]
Laura Semler
President
CSV Solutions Inc
Cincinnati, OH, United States
[email protected]
Laura Cannon
Researach Coordinator
Medacta USA
Eustis, FL, United States
[email protected]
Lauren Kamer
Senior Regulatory Affairs Specialist
Biomet 3i LLC
Palm Beach Gardens, FL, United States
[email protected]
Lauren Nicholes
Regulatory Compliance Specialist
DePuy Synthes
West Chester, PA, United States
[email protected]
Laura Eder
Manager, Regulatory Affairs
TOLMAR Inc.
Fort Collins, CO, United States
[email protected]
Laurel Clark
Associate Regulatory Affairs Project
Manager
Perrigo Company
Allegan, MI, United States
[email protected]
Laurel Berzanskis
Regulatory Affairs Officer
Materialise
Leuven, Non-US, Belgium
[email protected]
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
[email protected]
Laurie Lenkel
Ombudsman
FDA
Silver Spring, MD, United States
[email protected]
Lawrence Emere
QA ASSOCIATE
PREPHARM
TRENTON, NJ, United States
[email protected]
Leanna Lomax
Program Analyst
Food and Drug Administration
Silver Spring, MD, United States
[email protected]
Leanne Sleer
Senior Medical Writer
INC Research
Washington, DC, United States
[email protected]
Lee Clermont
Director of Quality
Global Interconnect
Pocasset, MA, United States
[email protected]
Lei Li
VP, Clinical and Regulatory Affairs
Veritas Genetics Inc
Danvers, MA, United States
[email protected]
Lei Li
Clinical and Regulatory Affairs
Veritas Genetics
Danvers, MA, United States
[email protected]
Lena Shafir
Regulatory Product Manager
EMC
Feasterville, PA, United States
[email protected]
Leona Saunders
Associate Director of RA and QA
Curis
Lexington, MA, United States
[email protected]
Liat Talias
Regulatory Affairs and QA Project Manager
MedialCS
Kfar Malal, Non-US, Israel
[email protected]
Lilach Weisblat-Hershkovich
CEO
Quapedia
Israel, Non-US, Israel
[email protected]
Lili Jiang
Regulatory Affair Manager
Guangzhou Henovcom Bioscience Co., Ltd.
Guangzhou, Non-US, China
[email protected]
Lily Goldstein
QA/RA Director
BeamMed Ltd
Petah Tikva, Non-US, Israel
[email protected]
Linna Wei
Principal Associate, RA-CMC
Genzym A Sanofi Company
Westborough, MA, United States
[email protected]
Lisa Ballanco
Senior Business Anaylst
CSC
Norristown, PA, United States
[email protected]
Linda Grasfeder
Senior Clinical Pharmacologist and
Pharmacokineticist
Nuventra
Durham, NC, United States
[email protected]
Lisa Crockett
Vice President, Regulatory Affairs
InVivo Therapeutics
Cambridge, MA, United States
[email protected]
Lisa Gallatin
Director of Regulatory
Vascular Solutions
Maple Grove, MN, United States
[email protected]
Lisa Pritchard
Senior Director of Regulatory Affairs
EnteroMedics, Inc.
Saint Paul, MN, United States
[email protected]
Lisa Wegman
Quality Engineer
self-employed
Reading, PA, United States
[email protected]
Lixia Wang
Medical Research Scientist
FDA China Office
Beijing, Non-US, China
[email protected]
London Toney
Scientific Project Analyst
NIH
Rockville, MD, United States
[email protected]
Loretta Chi
Sr. Regulatory Policy Analyst
FDA
Silver Spring, MD, United States
[email protected]
Lori Rolfe
QA Officer
Microbac Laboratories Inc., WNC
WIlson, NC, United States
[email protected]
Lorie Laird
Regulatory Affairs Manager
Scanadu
Mountain View, CA, United States
[email protected]
Lucrezia Hinman
Director, Regulatory Affairs
County Line Pharmaceuticals
Brookfield, WI, United States
[email protected]
Luis Lopes
QA & RA Manager
Lopes Business Solutions
Fort Myers, FL, United States
[email protected]
Lucile Marron
QA/RA expert
Surigiqual institute
grenoble, Non-US, France
[email protected]
Luis Velásquez
Licenciado en Biología
LMB H.COLICHON S.A.C
lima, ME, Peru
[email protected]
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
[email protected]
Luz Escolar
Regulatory Affairs
OMT LLC
Fort Lauderdale, FL, United States
[email protected]
Luz Villamizar
Principal RA Specialist
Immucor
Warren, NJ, United States
[email protected]
Lynn Berkowitz
Principal Consultant
EMC
Evergreen, CO, United States
[email protected]
Lynn Wilson
Clinical and Regulatory Project Manager
Ximedica, LLC
Providence, RI, United States
[email protected]
Lynne Housand
Scientist
AEgis Technologies Group
Orlando, FL, United States
[email protected]
Lynne Witkowski
Manager Regulatory Affairs
Medela
McHenry, IL, United States
[email protected]
Lyudmila Kipnis
RA consultant
Independent
Seattle, WA, United States
[email protected]
Maayan Elias
BDO
Pepticom
jerusalem, Non-US, Israel
[email protected]
Madelein English
Consultant
Self employed consultant
Cape Town, Non-US, South Africa
[email protected]
Madhu Malo
President & CEO
Atoxin Biotech, LLC
Worcester, MA, United States
[email protected]
Madhuri Jerfy
Senior Scientist
Boehringer Ingelheim
Ridgefield, CT, United States
madhuri.j[email protected]
Madhusoodana Nambiar
Policy Advisor
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Madhvi Upender
CEO
Awarables, Inc.
Potomac, MD, United States
[email protected]
Maged Batis
Sr. R&D Pharmacist
Riyadh Pharma
RIYADH, Non-US, Saudi Arabia
[email protected]
Mahesha Rajapakse
Manager, Quality Assurance and
Regulatory Compliance
ReliefBand Technologies
Chicago, IL, United States
[email protected]
Maitri Sanghavi
Scientist
Dr reddys
Hyderabad, Non-US, India
[email protected]
Mahmoud Ghannam
Project leader
Hikma Pharmaceuticals
Amman, Non-US, Jordan
[email protected]
Mairlyn Waxberg
Senior Princple & Business Expansion
Regulatory and Quality Solutions
Monoevill, PA, United States
[email protected]
Majid Hasheminejad
President/Owner
4-1-1 CONSULTING SERVICES, LLC
York, PA, United States
[email protected]
Maliha Ilias
Product Development Specialist
NIAID
Bethesda, MD, United States
[email protected]
Mallik Metukuri
Medical Affairs Scientist
INC Research
Raleigh, NC, United States
[email protected]
Mana Shirazi-Kia
Quality system manager
LGT medical
Vancouver, Non-US, Canada
[email protected]
Manan Hathi
Staff Regulatory Affairs Specialist
Stryker
Flower Mound, TX, United States
[email protected]
Manan Patel
Research Officer - Regulatory Affairs
Sun Pharmaceutical Industries Limited
Vadodara, Non-US, India
[email protected]
Manikanta K
Regulatory Affairs Executive
Gland Pharma Limited
Hyderabad, Non-US, India
[email protected]
Marc Neubauer
CSO Device Specialist
FDA
Baltimore, MD, United States
[email protected]
Marc Smith
Owner
Elsmar
West Chester, OH, United States
[email protected]
Marcella Martin
Regulatory Associate II
TOLMAR Inc.
Fort Collins, CO, United States
[email protected]
Marcia Howard
Senior Director, Regulatory & Scientific
Affairs
Consumer Healthcare Products Association
Washington, DC, United States
[email protected]
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
[email protected]
Margaret Mangano
QA/RA Leader
Belmont Instrument Corporation
Billerica, MA, United States
[email protected]
Maria Caturla
Clinical Research
University of Pennsylvania
Philadelphia, PA, United States
[email protected]
Maria Cristina Vaccari
QA Manager
RAND S.r.l.
Medolla, Non-US, Italy
[email protected]
Maria Tsyrlin
QA/RA Assistant
BeamMed Ltd
Petah Tikva, Non-US, Israel
[email protected]
Maribel Rodriguez-Torres
Compliance Specialist
Integra
Anasco, Non-US, Puerto Rico
[email protected]
Marie Dorat
Regulatory Quality Specialist
BioLegend
San Diego, CA, United States
[email protected]
Marie Christensen
Regulatory Affairs Administrator
Medtronic
Stockholm, Non-US, Sweden
[email protected]
Marie-Pierre Fafard
R&D Projects Engineer
Nuvo Research Inc.
Montreal, Non-US, Canada
[email protected]
Marietsy Pujol
Research Analyst
ISCI / University of Miami Miller School
Miami, FL, United States
[email protected]
Mariusz Szkudlinski
Exec. Vice President & CSO
Trophogen
Rockville, MD, United States
[email protected]
Mark Leuschner
VP Operations
Ionetix Corporation
Newfields, NH, United States
[email protected]
Mark Pohl
Attorney
Pharma Patent Attorneys, LLC
Morristown, NJ, United States
[email protected]
Mark Schenk
President
Mark F Schenk Consulting
West Lawn, PA, United States
[email protected]
Mark Simmons
Director of QA / RA
J-Pac Medical, LLC
Somersworth, NH, United States
[email protected]
Mark Roessel
VP Regulatory Affairs and Quality
Assurance
Concert Pharmaceuticals
Lexington, MA, United States
[email protected]
Mark Simmons
Director QA RA
J-Pac Medical
Somersworth, NH, United States
[email protected]
Mark Sistare
Regulatory Affairs Manager
BD
Durham, NC, United States
Mark_Sis[email protected]
Mark Wita
VP QA/RA
Pharmaceutical Associates, LLC
Tampa, FL, United States
[email protected]
Marlon Jackson
Admin
Shimadzu
Columbia, MD, United States
[email protected]
Marsha Meehan
Proposal Manager
MGM Editorial Consulting
Silver Spring, MD, United States
[email protected]
Martha Gutierrez
Quality Engineer
Fitopharma
Guadalajara, Non-US, Mexico
[email protected]
Marvin Garrett
Vice President RA/Q
Aerie Pharmaceuticals
Irvine, CA, United States
[email protected]
Mary Clark
General Manager
PharmaGenetico
San Antonio, TX, United States
[email protected]
Mary Elicone
Associate Director
Sanoif
Bridgewater, NJ, United States
[email protected]
Maryalice Worden
Sr. Director Regulatory Affairs
Tetraphase Pharmaceuticals
Watertown, MA, United States
[email protected]
Maryam Etemad
qualified person
rastagene
hamburg, Non-US, Germany
[email protected]
Maryanne Wong
Nuclear Pharmacist/Quality Assurance
Officer
Hamamatsu/Queen's PET Imaging Center
(cyclotron)
Honolulu, HI, United States
[email protected]
Matan Neeman
Head of Q&R - ICAP
Philips
Haifa, Non-US, Israel
[email protected]
Mark Simmons
Director Quality and Regulatory Affairs
J-Pac Medical
Somersworth, NH, United States
[email protected]
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
[email protected]
Matthew Allan
Drug Safety Coordinator
Dohmen Life Science Services
Emeryville, CA, United States
[email protected]
Matthew Baldwin
Statistician II
TOLMAR Inc
Fort Collins, CO, United States
[email protected]
Maureen Rath
Senior Manager, Regulatory Affairs
Perrigo Company
Minneapolis, MN, United States
[email protected]
Maurice Briggs
Principal
GMB Bio:Pharma Development
Harleysville, PA, United States
[email protected]
Meena Chettiar
QA/RA Manager
ProMed Pharma
Minneapolis, MN, United States
[email protected]
Meena Rani
Director, QA & RA
Polygen Pharmaceuticals LLC
Edgewood, NY, United States
[email protected]
Meena Shah
General Manager - Regulatory
Geltec Pvt Ltd
Mumbai, ME, India
[email protected]
Meg Mucha
Director of Global RA
Mortara Instrument, Inc
Milwaukee, WI, United States
[email protected]
Meghashyam Malashetter
Management Trainee
Sequent Scientific
Mumbai, Non-US, India
[email protected]
Mehwish Saeed
Senior Executive QA Document Control
Scilife Pharma
Karachi, Non-US, Pakistan
[email protected]
Meir Silver
President
Molecular Innovations Technology
Beit Shemesh, Non-US, Israel
[email protected]
Meira Kain
CEO
pH2O Water Technologies
Kfar Aviv, Non-US, Israel
[email protected]
Meisam Honarvar Nazari
chief technology officer
Integrated Medical Sensors
Irvine, CA, United States
[email protected]
Melaney Bouthillette
Sr Scientist
Olivo Labs
Cambridge, MA, United States
[email protected]
Melissa Smith
Senior Consultant
MJQuality Solutions, llc
bedford, MA, United States
[email protected]
Meriem Gaval Cruz
Regulatory Science Specialist
Cote Orphan
Silver Spring, MD, United States
[email protected]
Miao Gu
Regulatory Affairs
Yabao Pharmaceutical Group
Beijing, Non-US, China
[email protected]
Michael Alouane
Director of Quality
American Surgical Company
Salem, MA, United States
[email protected]
Michael Chellson
Principal consultant
Pathways to success consulting
Round Lake, IL, United States
[email protected]
Michael Dawson
Sr. Director of RA/ Deputy General Counsel
Precision Spine, Inc.
Parsippany, NJ, United States
[email protected]
Michael Beckelic
Maager, Quality Assurance and Regulatory
Affairs
Sebela Pharmaceuticals Inc.
Roswell, GA, United States
[email protected]
Michael El-Shammaa
Supervisory interdisciplinary engineer
FDA
Bethesda, MD, United States
[email protected]
Michael Macfarland
Compliance and GMP Manager
ACIC Fine Chemicals, Inc.
Brantford, Non-US, Canada
[email protected]
Michael Morello
Regulatory Consultant
Independent Regulatory Consultant
San Diego, CA, United States
[email protected]
Michael Ok
Post-Doc
University of Wuerzburg
Wuerzburg, Non-US, Germany
[email protected]
Michael Patz
VP, Clinical and Regulatory
Viatar CTC Solutions
Lowell, MA, United States
[email protected]
Michail Pankratov
Principal
MMP Medical Associates, LLC
Waltham, MA, United States
[email protected]
Michele Burtness
Regulatory
Pfizer
New York, NY, United States
[email protected]
Michael Freeling
Founder
ScrubSync
Bend, OR, United States
[email protected]
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
[email protected]
Michelle Maciejewski
QA Manager
Klocke of America Inc.
Ft Myers, FL, United States
[email protected]
Michelle Mathers
Branch Chief
USAMMDA
Frederick, MD, United States
[email protected]
Michelle Kliewer
Director
Boehringer Ingelheim
Ridgefield, CT, United States
[email protected]
Miguel Angel Carranza Moquillaza
Specialist Evaluator
digemid
Lima, Non-US, Peru
[email protected]
Milisha Bloodworth
Sr. Trade Customs Advisor
FedEx
Memphis, TN, United States
[email protected]
Milton Peña
Regulatory Affairs Analyst
MINSA
Lima, Non-US, Peru
[email protected]
Ming Anne Kuan
VP Reg
Neovii Biotech
Waltham, MA, United States
[email protected]
Mingjie Liu
Scientist
Essenlix
Monmouth Junction, NJ, United States
[email protected]
Minh Luu
Legal nurse consultant
Pepper Hamilton
Princeton, NJ, United States
[email protected]
Minjae Shin
Senior Manager
HPI Inc.
Rockville, MD, United States
[email protected]
Mira Pekova
Analyst
Artisan
Watertown, MA, United States
[email protected]
Miranda Raggio
Sr. Regulatory Program Manager
FDA-CDER-OND
Silver Spring, MD, United States
[email protected]
Miriam Cuenca Nespral
Hormones Regulatory Affairs Head
Laboratorios León Farma S.A.
León, Non-US, Spain
[email protected]
Mitul Patel
asst manager
sun pharma
vadodara, Non-US, India
[email protected]
Mohamed Abdeldayem
R&D pharmacist
Hikma pharmaceuticals
Cairo, Non-US, Egypt
[email protected]
Mohammad Salman
Director Product Development
Hovione
East Windsor, NJ, United States
[email protected]
Mohan Ratanchandani
VP Quality System
mdi Consultants, Inc.
Selden, NY, United States
[email protected]
Moira Barton-Varty
Sr Director Regulatory Affairs
Stryker Sustainability Solutions
Tempe, AZ, United States
[email protected]
Mona Sharma
Senior Manager
Sentiss Pharma Pvt Ltd
Gurgaon, Non-US, India
[email protected]
Monica Frazier
Integrated Product Development Associate
Rho
Chapel Hill, NC, United States
[email protected]
Monique Carter
Regulatory strategist
Pfizer
Collegeville, PA, United States
[email protected]
Monique Weitz
VP Regulatory Affairs
Virtus Pharmaceuticals
Tampa, FL, United States
[email protected]
Morgan Michalek
Senior Regulatory Affairs Associate
Sagent Pharmaceuticals
Schaumburg, IL, United States
[email protected]
Mourad Atlas
Mathematical Statistician
FDA/CDRH/OSB/DBS
Silver Spring, MD, United States
[email protected]
Muhammad Saiduzzaman
Director of Quality
Circuit Works Corporation
Waukegan, IL, United States
[email protected]
Muhammad Sarfaraz
Head of Plant Operations
Cirin Pharmaceuticals (Pvt) Ltd
Islamabad, Non-US, Pakistan
[email protected]
Muhammad Amin Jatoi
Production Lead
Novartis Pharma Pakistan ltd.
Jamshoro, Non-US, Pakistan
[email protected]
Muhammad Nazeer Ul Haque
Executive QA
Barrett Hodgson
Karachi, Non-US, Pakistan
[email protected]
Milad Khan
Manager, Global Regulatory Affairs
Janssen R & D
Raritan, NJ, United States
[email protected]
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
[email protected]
Muhammad Shahid
Asisstan Manager Regulatory Affairs
CKD Pharmaceutical Pakistan (Pvt) Ltd
Karachi, Non-US, Pakistan
[email protected]
Mukesh Sharma
Assistant Manager
Sentiss Pharma
Gurgaon, Non-US, India
[email protected]
Muna Faidi
Lab supervisor
University of Petra
Kalamazoo, MI, United States
[email protected]
Munish Mehra
Managing Director
Quantum BioPharma
Gaithersburg, MD, United States
[email protected]
N. Azima
REGULATORY SPEC.
GUMC
WASH, DC, United States
[email protected]
Nadia Harhen
Regulatory Affairs Manager
Qfix
Avondale, PA, United States
[email protected]
Nadine Ramos
General Biological Sciences
FDA CDRH OIR
White Oak, MD, United States
[email protected]
Nagaraj Tolnoorkar
QUALITY ASSURANCE
ALLURE LABS
HAYWARD, CA, United States
[email protected]
Nagarjuna Bhogadi
REGULATORY AFFAIRS
daewoong pharmaceuticals
HYDERABAD, GA, India
[email protected]
Najib Magee
Quality Assurance Specialist
SRI International
Menlo Park, CA, United States
[email protected]
Nana Banafo
Manager Clinical Surveillance
CooperSurgical
Trumbull, CT, United States
[email protected]
Nancy Karaszkiewicz
Instructor
GDIT
Frederick, MD, United States
[email protected]
Nancy Mathewson
Director, Regulatory Affairs
PPD
Rockville, MD, United States
[email protected]
Nancy Mckeown
TEST
TEST
TEST, AL, United States
[email protected]
Nancy Njuguna
Consultant
Self
Carmel, IN, United States
[email protected]
Nancy Pirt
Director, Regulations Staff (CDRH)
FDA
Silver Spring, MD, United States
[email protected]
Narayan Dasuri
Student
Northeastern Univesity
Boston, MA, United States
[email protected]
Narendira Kumar
Senior Manager
Orchid Healthcare
Chennai, Non-US, India
[email protected]
Narendrasinh Gohil
Quality Assurance
Pharmaceutics International Inc.
Hunt Valley, MD, United States
[email protected]
Natalia Remmel
Sr. Regulatory Affairs
CD Diagnostics
Claymont, DE, United States
[email protected]
Natalie Elia
Quality Control/Qualitu Assurance
Specialist
Immunostics, Inc.
Ocean, NJ, United States
[email protected]
Nathan Anderson
Regulatory Compliance
Janssen
Horsham, PA, United States
[email protected]
Natalya Stuherck
Regulatory Affairs -CMC
Daiichi Sankyo
Edison, NJ, United States
[email protected]
Nathalie Innocent
Regulatory Associate
Teva Pharmaceuticals
Norristown, PA, United States
[email protected]
Nathan Johnston
Regulatory Affairs Associate
Ei LLC
Kannapolis, NC, United States
[email protected]
Navneet Sharma
VP of Quality and Regulatory
Daktari Diagnostics, Inc.
HOPKINTON, MA, United States
[email protected]
Nazish Naz
Sr.Executive
The Searle Company ltd
Karachi, Non-US, Pakistan
[email protected]
Neena Saini
Sr. Director, Production
United Therapeutics
Silver Spring, MD, United States
[email protected]
Neha Taneja
Senior Executive
Sentiss Pharma
Gurgaon, Non-US, India
[email protected]
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
[email protected]
Nehru Gaddipati
CEO
Nines Pharma
New York, NY, United States
[email protected]
Nelson Marquina
R&D Director
USA Laser Biotech Inc.
Richmond, VA, United States
[email protected]
Nelson Marquina
Director R&D
USA Laser Biotech
Richmond, VA, United States
[email protected]
Nelson Quiroga
Profesional assessor
INHRR
Caracas, Non-US, Venezuela
[email protected]
Nicholas Tantillo
Head Regulatory Strategy and Policy
Sandoz Inc.
Princeton, NJ, United States
[email protected]
Nicole Dove
QA/RA Manager
Summit Medical
St. Paul, MN, United States
[email protected]
Nicole Spaniel
Principal Specialist I
R&Q Solutions, Inc.
Pittsburgh, PA, United States
[email protected]
Niedre Heckman
Sr. Mgr., Global Regulatory Affairs
Baxalta
Westlake Village, CA, United States
[email protected]
Niki Spaniel
Principal Specialist I
R&Q Solutions
Pittsburgh, PA, United States
[email protected]
Niki Tsagaratos
Senior Specialist, Regulatory Affairs
Catalent Pharma Solutions
St. Petersburg, FL, United States
[email protected]
Ninad Gujar
Director, Regulatory and Quality
Neurologica (Samsung)
Waltham, MA, United States
[email protected]
Nirav Sevak
Regulatory Affairs
Nostrum Laboratories, Inc.
Kansas City, MO, United States
[email protected]
Noah Papas
Chief Technology Officer
Abililife
Pittsburgh, PA, United States
[email protected]
Nuha Nazy
CEO
Z-axis Lab
Chicago, IL, United States
[email protected]
Nina Ruiz
Manager- Regulatory Compliance and
Sustainability
Conair Corporation
Stamford, CT, United States
[email protected]
Nithin Ramadurai
Senior Engineer, Product & Process
Development
Olivo Labs, LLC
Cambridge, MA, United States
[email protected]
Obaid Ali
Federal Inspector of Drugs
Drugs Regulatory Authority of Pakistan
Karachi, Non-US, Pakistan
[email protected]
Odelya Lazimi
director of international trade policy
Israeli Embassy
Washington, DC, United States
[email protected]
Odessa Quintyne
Director of Quality and Regulatory Affairs
Biorep Technologies
Miami, FL, United States
[email protected]
Odeya Tsur
Regulatory Affairs Department
CTS Pharmaceutical Industries Ltd
Hod Hasharon, Non-US, Israel
[email protected]
Odunayo Obisesan
VP, Clinical Services
MedicPharm Inc
Highland, MD, United States
[email protected]
Oiza Kuyinu
Research Specialist Ophthalmology
The Emmes Corporation
Rockville, MD, United States
[email protected]
Olivia Lau
Microbiology/Regulatory Specialist
Beaver-Visitec International
Waltham, MA, United States
[email protected]
Olof Ljunghusen
CEO
Science and Innovation AB
Lund, Non-US, Sweden
[email protected]
Oluoje Karma Dele
Personnel Executive
Zeemorg Resources Limited
Lagos, Non-US, Nigeria
[email protected]
Oluyinka Green
Regulatory Consultant
Concert Pharmaceuticals
Lexington, MA, United States
[email protected]
Orandrach Drach
Managing Director
Defense-Lab
Givat Ada, Non-US, Israel
[email protected]
Oussama Hassan
Medical director
Analog Medical Technologies LLC
Austin, TX, United States
[email protected]
Pam Rocksted
Senior Regulatory and Quality Specialist
Regulatory and Quality Solutions
Westminster, CO, United States
[email protected]
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
[email protected]
Pamela Mason
Vice President, Quality and Compliance
MPS, LLC
Chicago, IL, United States
[email protected]
Paola Lucchetti
Responsible for exporting procedures
BYM! S.r.l.
Caserta, Non-US, Italy
[email protected]
Patricia Ryan
Senior Manager, Regulatory Affairs
La Jolla Pharmaceutical Company
San Diego, CA, United States
[email protected]
Patricia Bewley
Project Manager
US Army MRMC
Frederick, MD, United States
[email protected]
Patricia Karausky
RN_ Research Facilitator
University of Pittsburgh/CTSI
Pittsburgh, PA, United States
[email protected]
Patricia Maguire
Regulatory Scientist
TekTeam LLC
Palo Alto, CA, United States
[email protected]
Patricia Egea
Regulatory Affairs Specialist,
Pharmacovigilance
Catalent Pharma Solutions
St. Petersburg, FL, United States
[email protected]
Patricia Termini
Manager Regulatory Affairs
Chiltern International
Cary, NC, United States
[email protected]
Patrick Baker
Oakworks
Oakworks, Inc
New Freedom, PA, United States
[email protected]
Patrick Lim
QA/RA manager
Hiossen Inc.
Fairless Hills, PA, United States
[email protected]
Patrick Lim Soo
Senior Scientist
Blend Therapeutics
Watertown, MA, United States
[email protected]
Paul Buccetti
RF
Aplicare
Meriden, CT, United States
[email protected]
Paul Ginos
Director of Manufacturing
Klocke of America Inc.
Ft Myers, FL, United States
[email protected]
Paula Costa
Analisty
Prati Donaduzzi
Toledo, Non-US, Brazil
[email protected]
Paulette Midgette
Manager, Regulatory Affairs
Accenture
Philadelphia, PA, United States
[email protected]
Paulette Midgette
Manager, Regulatory Affairs
Accenture
Philadelphia, PA, United States
[email protected]
Pavadi Subramaniam
Senior Manager
OHM LABS INC
New Brunswick, NJ, United States
[email protected]
Pedro Paz
Director of Quality
Cerno Pharmaceuticals
Hialeah, FL, United States
[email protected]
Pelumi Badmus
President
Hero's Shelter, Inc.
Hesperia, CA, United States
[email protected]
Penelope Ernould
Quality Engineering Manager
SCIEX
Concord, Non-US, Canada
[email protected]
Penelope Ward
Chief Medical Officer
Karus Therapeutics Ltd
Oxford, Non-US, United Kingdom
[email protected]
Peter Grier
Sr. Manager
mantech
columbia, MD, United States
[email protected]
Peter Scott
Sr Director Regulatory Affairs
Immucor
Warren, NJ, United States
[email protected]
Peter Webner
SVP
Zevacor Molecular
Noblesville, IN, United States
[email protected]
Peter Ohanian
Principal
NorthShore Quality and Regulatory
Solutions, LLC
Windham, NH, United States
[email protected]
Peter Wu
Head of QC
ChemPacific Corporation
Baltimore, MD, United States
[email protected]
Phani Puppala
Quality Coordinator
Arthrosurface
Franklin, MA, United States
[email protected]
Phil Triolo
Sr. Consultant
Phil Triolo and Associates LC
Salt Lake City, UT, United States
[email protected]
Phil Wyman
CEO/President
Digital Hospital, Inc.
San Jose, CA, United States
[email protected]
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
[email protected]
Pj Pardo
Director, Regulatory & Clinical Affairs
Organ Recovery Systems
Itasca, IL, United States
[email protected]
Prabhakar Thota
Sr. Manager
Biological E Ltd
Hyderabad, Non-US, India
[email protected]
Pradeep Jandhyala
Manager
EMC
Sydney, Non-US, Australia
[email protected]
Pragnya Bakka
Regulatory affairs coordinator
Syneron-Candela
Boston, MA, United States
[email protected]
Prajakta Palshikar
Manager - Regulatory Affairs
Alpha MD Pvt Ltd
Mumbai, Non-US, India
[email protected]
Prajit Acharya
Senior Research
Indian Council of Medical Research
Delhi, WI, India
[email protected]
Prasanna Palle
Regulatory Affairs Associate I
Amneal Pharmaceuticals
Hauppauge, NY, United States
[email protected]
Prashant Vagadia
Executive
Sun Pharmaceutical Industries Ltd.
Vadodara, Non-US, India
[email protected]
Praveenkumar Aluru
Associate scientist
Syngene international
bengalore, Non-US, India
[email protected]
m
Priscilla Ejimofor
CEO
Regina Mundi Inc
Jacksonville, FL, United States
[email protected]
Praveenkumar Patil
Academia
Government Medical college
Dhule, Non-US, India
[email protected]
Prema Krishna
Drug Safety PVG consultant
Freelanace-Drug Safety
Chester Springs, PA, United States
[email protected]
Prithul Bom
Senior Director
CHILTERN
Minneapolis, MN, United States
[email protected]
Priti Rajda
DGM-Regulatory Affairs
Ipca Laboratories Limited
Mumbai, Non-US, India
[email protected]
Pushpa Makkikana
Prinicipal Quality Consultant
WIPRO LIMITED
Bangalore, Non-US, India
[email protected]
Qiang Cao
Quality Assurance and Regulatory Affairs
IZI Medical Products
Owings Mills, MD, United States
[email protected]
Qin Li
staff fellow
FDA
Silver Spring, MD, United States
[email protected]
Qun Zhang
Sr. Manager
Prinston Pharmaceutical Inc.
cranbury, NJ, United States
[email protected]
R. William Soller, Phd
President
Soller Regulatory & Research Services, d
Houston, TX, United States
[email protected]
Radha Ramesh
Head of assurance, life sciences
TCS
Bridgewater, NJ, United States
[email protected]
Rafael Comas
Head of Regulatory Affairs
PROCAPS S.A.
BARRANQUILLA, Non-US, Colombia
[email protected]
Rafael Gaitan
Partner
Suarez Gaitan
Coral Gables, FL, United States
[email protected]
Raghavendra A
Consultant
WIPRO LIMITED
Bangalore, Non-US, India
[email protected]
Raghunadha Reddy Seelam
Post Doc
University of Maryland
Baltimore, MD, United States
[email protected]
Raghunandhan Painoori
Assistant Manager
Novel Laboratories, Inc.
Somerset, NJ, United States
[email protected]
Ragunath Muniandy
Regulatory Affairs Specialist
Black Diamond Video
Richmond, CA, United States
[email protected]
Rahul Raj
Sr.Executive
iMEDGLOBAL
Banglore, Non-US, India
[email protected]
Rajani Gandhari
Regulatory Associate
Igi labs
Buena, NJ, United States
[email protected]
Rajesh Kalle
Software Engineer
HCL Technologies
Chennai, TN, Indonesia
[email protected]
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
[email protected]
Rajesh Pasupuleti
Solution Architect
HCL
Chennai, Non-US, India
[email protected]
Rajib Baishnab
Executive, Global Regulatory Affairs
Square Pharmaceuticals Ltd., Bangladesh
Dhaka, Non-US, Bangladesh
[email protected]
Rakesh Chaurasia
Head Drug Regulatory Affairs
PT DexaMedica
Tangerang, Non-US, Indonesia
[email protected]
Rakhi Dalal
Toxicologist
US FDA
Silver Spring, MD, United States
[email protected]
Rambabu Mogali
Assistant.General Manager
Raks pharma Pvt. Ltd (Amneal group)
Visakhapatnam, Non-US, India
[email protected]
Rana Tbaishat
academic advisor
SACM
sterling, VA, United States
[email protected]
Raphaël Guillot
Consultant
The Biotech Quality Group
Neuchatel, Non-US, Syria
[email protected]
Rashid Mureed
Manager
PharmEvo Pvt. Ltd. Pakistan
Karachi, PA, Pakistan
[email protected]
Rashmika Patel
Protocol coordinator
NIH
rockville, MD, American Samoa
[email protected]
Ravikiran Gouni
Executive-Regulatory Affairs
Amneal Pharmaceuticals
Ahmedabad, Gujarat, Non-US, India
[email protected]
Raymond Austin
QA Engineer
MES Ltd
Netanya, Non-US, Israel
[email protected]
Rebecca Cuniff
Senior Regulatory Affairs Associate
First Priority, Inc.
Elgin, IL, United States
[email protected]
Rebecca Spelich
Sr. Regulatory and Quality
R&Q
Akron, OH, United States
[email protected]
Rebekah Morrow
Product Regulatory Representative
Eastman Chemical Company
Kingsport, TN, United States
[email protected]
Reji Paalangara
As Pr Scientist
Merck Animal Health
Madison, NJ, United States
[email protected]
Rem Siekmann
Principal Engineer
R&Q Solutions LLC
Monroeville, PA, United States
[email protected]
Renae Dixon
Associate Directory of Regulatory Affairs
Century Pharmaceuticals
Indianapolis, IN, United States
[email protected]
Renata Lavach
Regulatory Strategist
Scimedx Corporation
Dover, NJ, United States
[email protected]
Rene Flores
VP Operations
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
[email protected]
Renuka Krishnan
Director, Regulatory Affairs
Obalon Therapeutics
San Diego, CA, United States
[email protected]
Reshmi Rose
Technical Lead
Wipro Technologies
Boulder, CO, United States
[email protected]
Revathi Chapa
scientist
Dr.Reddys
hyderabad, IN, India
[email protected]
Rhonda Alexander
Senior Regulatory Specialist
Registrar Corp
Hampton, VA, United States
[email protected]
Richard Ferguson
Assoc. Director of Production
Wes Pharma
Westminster, MD, United States
[email protected]
Richard Lee
Regulatory Compliance Analyst
Stryker Endoscopy
San Jose, CA, United States
[email protected]
Rick Fletcher
QA Director
CHALGREN ENTERPRISES
GILROY, CA, United States
[email protected]
Rick Gaykowski
Corp. VP, Regulatory/Quality/Clinical
Affairs
Perseon
Salt Lake City, UT, United States
[email protected]
Rick Wallsten
Consultant
Mount Sinai
Rye, NY, United States
[email protected]
Robert Bard
Managing Director
HTC LLC
Northville, MI, United States
[email protected]
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
[email protected]
Robert Howard
Manger, Regulatory Affairs
NASP
Franklin, NJ, United States
[email protected]
Robert Lee
regulatory affairs specialist
abbott medical optics
Sunnyvale, CA, United States
[email protected]
Roberta Ziccarelli
Clinical Drug Editor (Pharmacist)
Wolters Kluwer
Indianapolis, IN, United States
[email protected]
Roie Dahan
Co-Founder and Manager
ORRAD Software ltd.
Yakum, Non-US, Israel
[email protected]
Ronny Brown
Branch Chief
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Robert Kowal
Director, Risk Management and Criticality
Analysis
Janssen Pharmaceutical
Raritan, NJ, United States
[email protected]
Robin Gergen
Manager of Standards and Product
Compliance
The ROHO Group
Belleville, IL, United States
[email protected]
Roohi Bano Obaid
Deputy Drugs Controller
Drug Regulatory Authority of Pakistan
Karachi, Non-US, Pakistan
[email protected]
Rory Krieger
founder
ABC2ZEN, LLC
Lakewood, CO, United States
[email protected]
Rosa Hsieha
Project Manager
NYU School of Medicine
New York, NY, United States
[email protected]
Rosa Lugo
Compliance Consultant
DKAR Group, LLC dba DGF group
San Juan, Non-US, Puerto Rico
[email protected]
Rose Zhao
Managing Director
Emprise Pharma LLC
Phoenixville, PA, United States
[email protected]
Rosetta Cavallo
President
Cavallo Research Associates, LLC
Darnestown, MD, United States
[email protected]
Ruchir Dave
Senior Executive
iMEDGlobal Solutions Pvt. Ltd
Bangalore, Non-US, India
[email protected]
Rudy Darju-Doe
Quality Manager
VGI medical
St Petersburg, FL, United States
[email protected]
Ruth Cavanagh
CMC Regulatory Affairs Executive
DS Biopharma
Dublin, Non-US, Ireland
[email protected]
Ruth Collins
Senior Regulatory Affairs Associate II
Sovereign Pharmaceuticals, LLC
Fort Worth, TX, United States
[email protected]
Ryan Ledwig
Operations & Project Manager
Practical Compliance
Brevard, NC, United States
[email protected]
Sabir Afzal
Sr. Rwgulatory Associate
APCER Pharma
New Delhi, Non-US, India
[email protected]
Sabrina Noorani
Clincal Strategist
AbiliLife
Pittsburgh, PA, United States
[email protected]
Sabrina Sharif
Regulatory Affairs Coordinator
S4Optik LLC
Tonawanda, NY, United States
[email protected]
Sagar Pimpalwar
Sr. Regulatory Affairs specialist
Steris
Mentor, OH, United States
[email protected]
Sailaja Chirravuri
officer regulatory affairs
Mylan
Bangalore, Non-US, India
[email protected]
Sailaja Chirravuri
officer regulatory affairs
Mylan
Bangalore, Non-US, India
[email protected]
Sajeeh P Ahammed
Quality Assurance
Julphar
Ras Al Khaimah, Non-US, United Arab
Emirates
[email protected]
Sam Wong
Regulatory Affairs Advisor
Neo Tech
San Marcos, CA, United States
[email protected]
Sally Berry
Chief Medical Officer
Tris Pharma
Monmouth Junction, NJ, United States
[email protected]
Salvadore Palomares
Vice President of Quality and Regulatory
Integra Biotechnical
Carlsbad, CA, United States
[email protected]
Samantha Kaltenbach
Quality Assurance Specialist
ISTO Technologies, Inc.
St. Louis, MO, United States
[email protected]
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
[email protected]
Sandesh Shetty
regulatory affairs senior executive
strides arcolab limited
bangalore, Non-US, India
[email protected]
Sandhyarani Kosuri
Manager
Belcher Pharmaceuticals LLC
Largo, FL, United States
[email protected]
Sandi Ordog
Manager Quality Systems
SCIEX
Concord, Non-US, Canada
[email protected]
Sandra Anderson
Associate Director, Regulatory Affairs
Teva Pharmaceuticals
Miami, FL, United States
[email protected]
Sandra Kircus
Manager, Regulatory Affairs CMC
Genzyme, A Sanofi Company
Boston, MA, United States
[email protected]
Sandy Figueroa
RA/QA Manager
Nubenco Enterprises Inc.
Paramus, NJ, United States
[email protected]
Sandy Liu
Senior Engineer
ITRI
Tainan, Non-US, Taiwan
[email protected]
Sandy Yu
QA Manager
Alliance Pharma
Malvern, PA, United States
[email protected]
Sang Min Shin
Manager
GCC
Yongin, Non-US, South Korea
[email protected]
Sanjay Gupta
Manager, Regulatory Affairs
Zoll Manufacturing Corporation
Pittsburgh, PA, United States
[email protected]
Sanjay Pradhan
R&D Regulatory Scientist
Nanoscope Technologies
Arlington, TX, United States
[email protected]
Sanket Trivedi
Regulatory Affairs Associate
Insmed Inc
Bridgewater, NJ, United States
[email protected]
Sanobar Parkar
Global Head and Director
Alpha MD Private Ltd
Mumbai, Non-US, India
[email protected]
Sara Siegler
CEO/Owner
Sara Elizabeth Siegler
Bedford, OH, United States
[email protected]
Sarah Bakker
Regulatory Affairs Associate
ACIC Fine Chemicals Inc.
Brantford, Non-US, Canada
[email protected]
Sarah Ellison
Regulatory Compliance Analyst
Stryker Endoscopy
San Jose, CA, United States
[email protected]
Sarah Ryu
Research Navigator
Johns Hopkins ICTR
Baltimore, MD, United States
[email protected]
Sarat Chandra Allena
Executive
GeneriCo LLC
Bangalore, Non-US, India
[email protected]
Sarika Pardhe
AGM -regulatory affairs
Flamingo Pharmaceuticals Ltd
Mumbai, Non-US, India
[email protected]
Sartaj Kaur-Hurrle
Quality and Regulatory Specialist
Evofem, Inc
San Diego, CA, United States
[email protected]
Sathya Ganesan
Regulatory Coordination manager
Grifols
Durham, NC, United States
[email protected]
Satish Tripathi
Senior Vice President
Ophthotech
Princeton, NJ, United States
[email protected]
Satya Ganti
VP (R&D)
WES Pharma Inc
Westminster, MD, United States
[email protected]
Scott Garrand
Regulatory Affairs Manager
PPD, Inc. Contractor for USAMMDA/US
Army
Fort Detrick, MD, United States
[email protected]
Seema Paliwal
Regulatory Affairs Specialist II
CardioFocus Inc.
Marlborough, MA, United States
[email protected]
Scott Zhang
Head of Quality and Regulatory Ultrasound
Philips
Andover, MA, United States
[email protected]
Sean Spence
Regulatory Affairs Manager
NICO Corporation
Indianapolis, IN, United States
[email protected]
Sekar Thirugnanam
Design engineer
HCL technologies Ltd
Chennai, Non-US, India
[email protected]
Selvaraja Elumalai
Manager
Appco Pharma LLC
Somerset, NJ, United States
[email protected]
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
[email protected]
Shaeann Cavanagh
Regional RA Manager
Agfa HealthCare
Greenville, SC, United States
[email protected]
Seung Taek Oh
Director
HPI INC
Rockville, MD, United States
[email protected]
Seung Yoo
General Manager
Access Bio, Inc.
Somerset, NJ, United States
[email protected]
Shagufta Sultan
Biostatistician
Health Canada
Ottawa, Non-US, Canada
[email protected]
Shahid Saleem
Owner
Zellers
lahore, Non-US, Pakistan
[email protected]
Shai Melcer
Executive Director
BioJerusalem
Jerusalem, Non-US, Israel
[email protected]
Shanaye Carr
QA Representative
AMS Diagnostics LLC
Weston, FL, United States
[email protected]
Shannon Kauffman
Quality Manager
Micropore, Inc.
Elkton, MD, United States
[email protected]
Shannon Valenti
Regulatory Compliance Facilitator
University of Pittsburgh
Pittsburgh, PA, United States
[email protected]
Shariq Mehmood
Sr. Executive Regulatory Affairs
Scilife Pharma Private Limited
Karachi, Non-US, Pakistan
[email protected]
Sharon Briggs
Sr. Manager, Regulatory Affairs
Medtronic
Jacksonville, FL, United States
[email protected]
Shawn Waynick
Regulatory Compliance Assistant
Permobil Inc.
Lebanon, TN, United States
[email protected]
Sheila Bello-Irizarry
Integrated Product Development Associate
Rho, Inc.
Chapel Hill, NC, United States
[email protected]
Sheila Kaplan
Washington Correspondent, STAT
Boston Globe Media
Washington, DC, United States
[email protected]
Shelby Becker
Regulatory and Quality Associate
Berlin Heart
The Woodlands, TX, United States
[email protected]
Sheri Glaub
Sr. Consultant
RMC Pharmaceutical Solutions
Longmont, CO, United States
[email protected]
Sherry Gregor
SVP Regulatory & Quality
A-S Medication Solutions LLC
Libertyville, IL, United States
[email protected]
Sherry Qiu
QA Manager
ChemPacific Corporation
Baltimore, MD, United States
[email protected]
Shikha Shukla
Regulatory Specialist
Siemens HealthCare Diagnostics
Tarrytown, NY, United States
[email protected]iemens.com
Shilpa Patel
Sr. RA Project Manager
Perrigo Company
Allegan, MI, United States
[email protected]
Shiying Tian
Associate Director
Abonpharmaceuticals
Northvale, NJ, United States
[email protected]
Shokoufeh Khodabandeh
Quality System Specialist
Profound Medical Inc.
Toronto, Non-US, Canada
[email protected]
Shoshi Kaganovsky
CEO
Alsho
Tel Aviv, Non-US, Israel
[email protected]
Shradha Gottumukkala
Regulatory Affairs Associate
Professional Disposables International, Inc.
Montvale, NJ, United States
[email protected]
Shree Koushik
Regulatory Scientist
Clinical RM
Damascus, MD, United States
[email protected]
Shruti Prasad
Chemist
WES Pharma Inc
Westminster, MD, United States
[email protected]
Shuiqing Qiu
Postdoc fellow
Johns Hopkins University
Baltimore, MD, United States
[email protected]
Shuyen Huang
Director, CMC
JTIHuang
RIVERWOODS, IL, United States
[email protected]
Simone John
Regulatory Affairs Specialist
National Cancer Institute
Rockville, MD, United States
[email protected]
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
[email protected]
Sireesha Alla
Senior Regulatory Associate
InnoPharma
Piscataway, NJ, United States
[email protected]
Sista Sugiarto
Quality Assurance Engineer
Varian Medical Systems
Palo Alto, CA, United States
[email protected]
Snigdha Bezawada
Regulatory Operations Manager
CCS Associates
Mountain View, CA, United States
[email protected]
Sohail Bashir
QA Manager
Standpharm Pakistan Ltd.
Lahore, WY, Pakistan
[email protected]
Soma Kalb
Director, IDE Program
FDA
Silver Spring, MD, United States
[email protected]
Sonia Wu
Senior Manager
Archigen Biotech Limited
Seoul, Non-US, South Korea
[email protected]
Sonia Haley
Regulatory consultant
Regulatory consulyant
Richmond, VA, United States
[email protected]
Sophie Payannet
Administrative Coordinator
Asklepion Pharmaceuticals LLC
Baltimore, MD, United States
[email protected]
Sophy Abraham
Head of Regulatory Affairs
Elite Laboratories Inc.
Northvale, NJ, United States
[email protected]
Spencer Jarvis
Regulatory Manager
Nu Skin Enterprises
Provo, UT, United States
[email protected]
Srinesh Naidu
Formulation Associate
Appco Pharma LLC
Somerset, NJ, United States
[email protected]
Srinivas Yandrapu
Associate Director
Dr.Reddy's Laboratories
Princeton, NJ, United States
[email protected]
Stacey Murakami
Radiopharmacist/ QA Officer
Queens Medical Center
Honolulu, HI, United States
[email protected]
Stacie Wehling
Consultant
SciLucent, LLC
Herndon, VA, United States
[email protected]
Stacey Harveyreid
Program Manager Small Business and
Entreprenuership
Maryland Department of Business and
Economic Development
Baltimore, MD, United States
Stacy
Ralston
[email protected]
Clinical & Regulatory Director
Molecular Matrix
Davis, CA, United States
[email protected]
Steph Cooke
President
Cooke Consulting
Acworth, GA, United States
[email protected]
Stephanie Skipper
Principal Consultant
Ticalion Quality Management Services
Chesapeake, VA, United States
[email protected]
Stephanie Bechtold
Biomedical Engineer
Food and Drug Administration
Silver Spring, MD, United States
[email protected]
Stephanie Harrington
Chief Executive Officer
Matrix Medical Devices LLC
Mentor, OH, United States
[email protected]
Stephanie Mendy
Law Clerk
Suarez Gaitan
Coral Gables, FL, United States
[email protected]
Stephanie Mizell
Clinical Trials Manager
General Dynamics Information Technology
Frederick, MD, United States
[email protected]
Stephen Haley
Chief Commercial Officer
Immudex
Fairfax, VA, United States
[email protected]
Stephen Weitzman
Exec. Dir
MedDATA Foundation
Columbia, MD, United States
[email protected]
Steve Krueger
Principal Consultant
MAK and Associates, LLC
Milwaukee, WI, United States
[email protected]
Steve Wolf
VP - QA & Regulatory
MedTorque, Inc.
Kenosha, WI, United States
[email protected]
Steven Abrams
Partner
Pepper Hamilton LLP
Philadelphia, PA, United States
[email protected]
Steven Demarco
Dir Preclinical Development
Ra Pharma
Cambridge, MA, United States
[email protected]
Stanley Huang
Research Fellow
FDA/CDRH
Silver Spring, MD, United States
[email protected]
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
[email protected]
Steven Peltier
VP Regulatory and Quality Compliance
Rcordati Rare Diseases Inc
Lebanon, NJ, United States
[email protected]
Storm Stillman
Co-Founder and CEO
Luminist
Coral Springs, FL, United States
[email protected]
Stuart Crowther
Senior Regulatory Specialist
Varian Medical Systems
Crawley, Non-US, United Kingdom
[email protected]
Subhas Malghan
Deputy Director
Food and Drug Administration
Silver Spring, MD, United States
[email protected]
Sudhakar Bandari
President
Aurex Labs
East Windsor, NJ, United States
[email protected]
Sue Farina
President
Proveris Scientific Corporation
Marlborough, MA, United States
[email protected]
Sue Gifaldi
Senior Compliance Manager
Janssen Pharmaceuticals
Rochester, NY, United States
[email protected]
Sue Wang
Manager/Tech Consultant
ITRI
ROCKVILLE, MD, United States
[email protected]
Su-Hsiu Wu
Lecturer
University of Rhode Island
Kingston, RI, United States
[email protected]
Sumitra Ravuru
trainee research associate
aurobindo pharma limited
hyderabad, Non-US, India
[email protected]
Susan Batchilder
Regulatory Affairs / Proj Mgmt
Dalhousie University
Halifax, Non-US, Canada
[email protected]
Susan Brocchi
Regulatory Affairs Specialist
Siemens Healthcare Diagnostics
Tarrytown, NY, United States
[email protected]
Susan Johnston
CEO
Innovate Medical, LLC
Johnson City, TN, United States
[email protected]
Susan Parker
Director Purchasing and Logistics
Kenmark Optical, Inc.
Louisville, KY, United States
[email protected]
Susan Telliard
Senior Director Regulatory Affairs
Horizon Pharma plc
Deerfield, IL, United States
[email protected]
Susi Antoniuk
Director-Regulatory Affairs
Acorda Therapeutics, Inc.
Ardsley, NY, United States
[email protected]
Suzan Davis
President & CEO
Global Regulatory Partners-LLC
waltham, MA, United States
[email protected]
Susan Neadle
Head, Combination Products CoE and Sr.
Director, DtV/QE
Janssen Pharmaceuticals
Jacksonville, FL, United States
[email protected]
Sushil Jaiswal
Executive Vice President - Corporate
Quality Assurance and Regulatory Affairs
Macleods Pharmaceuticals Limited
Mumbai, Non-US, India
[email protected]
Suzanne Delaney
Regulatory Affairs Manager
Portola Pharmaceuticals Inc
South San Francisco, CA, United States
[email protected]
Svetlana Spasova
assessment officer
Health Canada
Ottawa, Non-US, Canada
[email protected]
Syed Sameer
Deputy Manager
Searle
Karachi, Non-US, Pakistan
[email protected]
Syed Sameer
Deputy Manager
Searle
Karachi, Non-US, Pakistan
[email protected]
Takuya Hagiwara
Manager
Mitsui Chemicals,Inc.
Tokyo, Non-US, Japan
[email protected]
Tal Or
ceo
ATLASense Biomed Ltd.
Tel Aviv, Non-US, Israel
[email protected]
Tamala Wampler
Consultant QA & RA
Novus Management, LLC
Cincinnati, OH, United States
[email protected]
Tangela Nichols
Regulatory Analyst
Thermo Fisher Scientific
Frederick, MD, United States
[email protected]
Tania Lupu
QA-QC Direcdtor
Case Medical
South Hackensack, NJ, United States
[email protected]
Tânia Melo
Global Regulatory Compliance Leader
Shamir Optical
Porto, Non-US, Portugal
[email protected]
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
[email protected]
Taragh Keily
Project Manager
University College Cork
Cork, Non-US, Ireland
[email protected]
Teresa Faulkner
Medical Writer
Rho, Inc.
Chapel Hill, NC, United States
[email protected]
Terese 'Ter' Sinopoli
Director corporate compliance
Oticon medical
Somerset, NJ, United States
[email protected]
Teri Sinopoli
Director of corporate compliance
Oticon medical
Somerset, NJ, United States
[email protected]
Terrence Oakes
COO (Chief Operating Officer)
inseRT MRI
Madison, WI, United States
[email protected]
Terry Dixon
Director, RA
Catalent Pharma Solutions
St. Petersburg, FL, United States
[email protected]
Thierry Plouvier
CEO
TERALI
Fondettes, Non-US, France
[email protected]
Thom Demuth
Manager, Regulatory Affairs
Procter & Gamble
Mason, OH, United States
[email protected]
Terry Ingram
Manager Medical Events and Combination
Products
Abbvie
Waukegan, IL, United States
[email protected]
Thomas Clark
VP, QA & Prod Dev
Alva-Amco Pharmacal Cos., Inc.
Niles, IL, United States
[email protected]
Thomas Jeffers
VP, Govt. Affairs
Hill-Rom
Washington, DC, United States
[email protected]
Thomas Sebastian
Senior Scientist
Akonni Biosystems
Frederick, MD, United States
[email protected]
Thrilok P
Jr. Executive Regulatory Affairs
CaplinPoint Laboratories LTD,.
chennai, Non-US, India
[email protected]
Thu-Ha Duncan
President
PDI Works, LLC
Cleveland, TN, United States
[email protected]
Thomas Cronin
Director of Regulatory Affairs and
Compliance
Actuated Medical, Inc.
Bellefonte, PA, United States
[email protected]
Thomas Varricchione
Sr. Vice President, Clinical & Regulatory
Affairs
Ximedica, LLC
Providence, RI, United States
[email protected]
Tierra Brown
Regulatory Affairs Specialist
Terumo Cardiovascular Group
Baltimore, MD, United States
[email protected]
Tieuvi Nguyen
Branch Chief
FDA
Silver Spring, MD, United States
[email protected]
Tiffany Huang
Consultant
Autotelic Inc.
City of Industry, CA, United States
[email protected]
Tiffany Palmer
Biomedical Engineer
FDA
Silver Spring, MD, United States
[email protected]
Tim Quan
RA manager
Elekta
Beijing, Non-US, China
[email protected]
Tim Voeller
Quality Manager
Ducommun
Appleton, WI, United States
[email protected]
Timothy Good
Senior Quality Engineer
Blue Spark Technologies
Westlake, OH, United States
[email protected]
Tina Feld
Quality Assurance Assistant
Xcision Medical Systems, LLC
Columbia, MD, United States
[email protected]
Todd Courtney
Branch Chief
FDA
Silver Spring, MD, United States
[email protected]
Todd Milholland
Sr. Manager, Regulatory Affairs
Hansen Medical
San Jose, CA, United States
[email protected]
Tomas Alvidrez
QA Director
salter labs
El Paso, TX, United States
[email protected]
Tony Du
Epidemiologist
Fda
Silver Spring, MD, United States
[email protected]
Tony Raymond
VP of QA/RA and CCO
Gamma Medica, Inc.
Salem, NH, United States
[email protected]
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
[email protected]
Travis Siverson
RA/QA Manager
Birchwood Laboratories LLC
Eden Prairie, MN, United States
[email protected]
Tymissha Jackson
Senior Manager
Adaptimmune
Philadelphia, PA, United States
[email protected]
Uday Kompella
Chief Scientific Officer
Ocugen, Inc.
Englewood, CO, United States
[email protected]
Vagn Rasmussen
Vice President
DELTA
Roskilde, Non-US, Denmark
[email protected]
Valeria Alcon
scientific evaluator
Health Canada
Vancouver, Non-US, Canada
[email protected]
Valeria Weltin
Sr. Regulatory Affairs Associate
Johns Hopkins
Baltimore, MD, United States
[email protected]
Valerie Ahmuty
Sr. Director, Regulatory Affairs
TherapeuticsMD
Boca Raton, FL, United States
[email protected]
Valerie Shinault
Regulatory Affairs Associate
IGI Laboratories, Inc.
Buena, NJ, United States
[email protected]
Vana Poovala
Sr. RA Specialist
Atrium Medical Corp
Hudson, NH, United States
[email protected]
Vanessa Jacques
QA/RA Manager
Salimetrics
State College, PA, United States
[email protected]
Varsha Nainani
CEO
Self
Irving, TX, United States
[email protected]
Venkatarao Gaddam
Technical Manager
HCL
Chennai, Non-US, India
[email protected]
Venkatreddy Kumbam
senior scientist
ScieGen pharms Inc
Hauppauge, NY, United States
[email protected]
Vesper Ramos
Senior Staff Fellow
FDA CDRH
Rockville, MD, United States
[email protected]
Vikas Kumar
Senior Research Scientist
Fresenius
Gurgaon, Non-US, India
[email protected]
Vikram Krishnamachary
Student
UCLA
Los Angeles, CA, United States
[email protected]
Viktoriya Knez
Quality Sistem Manager
Bioprod d.o.o.
Ljubljana, Non-US, Slovenia
[email protected]
Vilma Naupari
Regulatory Affairs Analyst
DEGIMID
LIMA, Non-US, Peru
[email protected]
Virginia Morales
Principal Investigator
Fraternal Association Nuestra Dynastia
Castroville, CA, United States
[email protected]
Vishal Sachdeva
Research Associate
Sun Pharma Industries Limited
Sriganganagar, Non-US, India
[email protected]
Viswesh Achanta
RA Executive
Daewoong Pharmaceutical Co Ltd
Hyderabad, Non-US, India
[email protected]
Vivian Kelly
Regulatory Affairs Manager
Fidia Pharma USA Inc.
Parsippany, NJ, United States
[email protected]
Vladimir Roudik
Director of operations
AVAILIUS LLC
Linden, NJ, United States
[email protected]
Wade Halma
Director of Engineering
Evenflo Feeding, Inc.
West Chester, OH, United States
[email protected]
Walter Jump
President, CEO
Cornerstone Regulatory
Langhorne, PA, United States
[email protected]
Warren Crumplin
Regulatory Affairs Supervisor
Fine Chemicals Corporation
Cape Town, Non-US, South Africa
[email protected]
Wasim Iqbal
Executive QA
kaizen pharmacuticals karachi Pakistan
karachi, Non-US, Pakistan
[email protected]
Wei Zhang
Vice President
Youngtech Pharmaceuticals, Inc.
Cranbury, NJ, United States
[email protected]
Weiwei Hua
Manager
HPC
EDISON, NJ, United States
[email protected]
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
[email protected]
William Rose
Associate
Axinn, Veltrop & Harkrider
Washington, DC, United States
[email protected]
William Sutton
Deputy Director
DICE
Silver Spring, MD, United States
[email protected]
William Daniels
Lab Services Coordinator
Shell Developmental Services &
Laboratories
Colton, CA, United States
[email protected]
William Woods
Business Manager
TRI-K Industries
Denville, NJ, United States
[email protected]
Wolfgang Werner
VP RA&QM
Biovotion AG
Zurich, Non-US, Switzerland
[email protected]
Wuyi Wang
Director
ChemPacific Corp
Baltimore, MD, United States
[email protected]
Xia Yang
assistant
Jiangsu Hansoh
Lianyungang, Non-US, China
[email protected]
Xiaoting Wang
Regulatory Affairs Specialist
GW Pharmaceuticals
Durham, NC, United States
[email protected]
Xavier Canals-Riera
Director
Tecno-med Ingenieros Medical Tech
Consultants
Barcelona, Non-US, Spain
[email protected]
Xiaoting Wang
Regulatory Affairs Specialist
GW Pharmaceuticals
durham, NC, United States
[email protected]
Xiaoxi Wang
QA/QC manager
Advin Biotech
San Diego, CA, United States
[email protected]
Xiaoxia Li
Staff
Cleveland Clinic
Cleveland, OH, United States
[email protected]
Ximena Semensato
Regulatory Specialist
Baxter Healthcare
Round Lake, IL, United States
[email protected]
Xin Fang
Mathematical Statistician
FDA
Silver Spring, MD, United States
[email protected]
Xiting Yang
Statistician
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Xueru Mu
Marketing director
Shenda Endoscopy
Hackensack, NJ, United States
[email protected]
Xuxia Hu
Regulatory Affairs Manager
Reach,Inc
Tianjin, Non-US, China
[email protected]
Yaara Meller Ben Ezra
RA
biometrix medical
jerusalem, IL, Israel
[email protected]
Yael Goode
Senior Manager, Regulatory Affairs
Impulse Dynamics
Orangeburg, NY, United States
[email protected]
Yaji Xu
Mathematical Statistician
FDA/CDRH
Silver Spring, MD, United States
[email protected]
Yanxing Zhao
senior statistician
Otsuka Pharmaceuticals
Rockville, MD, United States
[email protected]
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co. Ltd.
Shanghai, Non-US, China
[email protected]
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co.Ltd.
Shanghai, Non-US, China
[email protected]
Yaolin Wang
Regulatory Affairs Specialist
Shanghai Hengrui Pharmaceutical Co.Ltd.
Shanghai, Non-US, China
[email protected]
Yaron Segal
CEO
BrainQ
Jerusalem, Non-US, Israel
[email protected]
Yasuyuki Shimoura
QA Specialist
Sysmex America Inc.
Lincolnshire, IL, United States
[email protected]
Yelena Rice
Medicines Quality
Eli Lilly and Company
Indianapolis, IN, United States
[email protected]
Yesmil Pena
Consultant
Consultant
Woodbridge, Non-US, Canada
[email protected]
Wilmarie Flores
Consumer Safety Officer
Food and Drug Administration
Silver Spring, MD, United States
[email protected]
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
[email protected]
Yi-Cheng Alex Liu
Research Associate
AROG Pharmaceuticals Inc.
Dallas, TX, United States
[email protected]
Yoon Jeong Choi
Manager
Genexine Inc.
Seoul, Non-US, South Korea
[email protected]
Yosh Mantinband
Product Manager
RenalSense ltd.
Jerusalem, Non-US, Israel
[email protected]
Ysabel Sonia Gutierrez Aures
PHARMACYST
DIGEMID
LIMA, Non-US, Peru
[email protected]
Yvonne Schleife
Regulatory & Quality Systems Manager
Acoustic MedSystems
Savoy, IL, United States
[email protected]
Zhijun Zhong
Project Manager
Chinese Medicines (Guangzhou) Ltd.
Guangzhou, Non-US, China
[email protected]
Zivjena Vucetic
VP, Global Clin Mkt Dev
Fujirebio
Malvern, PA, United States
[email protected]
Zulema Meares
QA Manager
Zygo Corp
Tucson, AZ, United States
[email protected]
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REdI Fall Conference 2015 - Participants List