Course Registration
Director
Form
Who Should AttendCourse Offering # 1104-205
Additional
Faculty
Generic
Drug Approvals
April 4–6, 2011 • New Brunswick, NJ
Dr. Mr. Ms.
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the same company, for the same course. Multiple discounts not applicable.
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receive written confirmation including detailed information
location – VIA EMAIL. If confirmation is not received two weeks prior to
the course please contact Customer Service.
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(4) weeks prior to the course start date for a refund. Applicants that cancel
less than four (4) weeks prior to the course will be issued a credit that can
Firsttowards
Day a future course up to one year from the date ofSecond
be used
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No refunds or credit will be issued for those who cancel less than ten (10)
working days before the course start date and/or do not attend the
scheduled course. Substitutions are permitted at any time. If for any
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airfare, hotel or other costs incurred by the registrant. Program content,
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in 18 industries including
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P.O. Box 7077Courses of Interest
East Brunswick, NJ 08816-7077
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Priority Code:
520
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Tuition payable in US funds net of all charges includes continental breakfast,
Who Should Attend
luncheon, breaks and course notes.
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Note: Payment is due before course start date.
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Objectives
Participants
Said:
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❏Past
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Invoice/Bill
MeHave
• Active Pharmaceutical Ingredients
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Education
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McLean, VA 22102. In obtaining this approval, The Center for
General
Information
Professional Advancement has
demonstrated
that it complies
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Day
with the ANSI/IACET Standards which are widely recognized
as standards of good practice internationally. The Center for
Professional Advancement is therefore authorized to offer IACET
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CEUs for its programs that qualify under the ANSI/IACET
Standards. CEUs will be awarded only upon successful completion
Participants
Haveall the
Said:
of the course,Past
i.e., attendance
at essentially
formal sessions
and submission of a course assessment/evaluation.
Recommended Reading
Security
code
April 4–6, 2011 Recommended Reading
New Brunswick, NJ
3 Ways To Register
First Day
Seco
Third Day
Fou
Generic Drug
Approvals
A Comprehensive Review of the Legal andSecond Day
Regulatory Requirements for Preparing
and Processing Abbreviated New Drug Fourth Day
Applications (ANDA's)
Course Topics Include:
Waxman-Hatch Act
Patent Protection and 180-Day Market Exclusivity
n Bioequivalence/Bioavailability
n Format and Content for an ANDA/CTD
n Pitfalls and Pointers When Dealing with the FDA
n Electronic Filing
n
n
The Center for Professional Advancement (CfPA)
is accredited by the Accreditation Council for
Pharmacy
Education
a provider of continuing
3 Ways
ToasRegister
pharmacy education. Continuing Education Units
(CEU) will be awarded only upon successful completion of the
course, i.e., attendance at all the formal sessions and submission
Second
of aFirst
course
evaluation. The CEU rate is 0.1 CEU per contact
hour;Day
Day
statement of credit will be mailed within six weeks. You will have an
opportunity to evaluate your successful completion of these course
objectives through a Learning Assessment. This program provides
Fourth
a knowledge-based
activity, applicable to both Pharmacists
and Day
Third Day
Technicians. This Program# 716-000-10-147-L04PT offers a total
of 18 contact hours.
Second Day
Day Information
General
• CMC Submissions in CTD Format
course id# 2050
Fourth Day
Course Co-Directors
Co-Directed by:
Robert J. Anderson, Esq.
General Counsel & Vice President, Regulatory Affairs
Nycomed US Inc.
Gary L. Yingling, Esq.
Partner
K&L Gates LLP
and
Rebecca L. Dandeker, Esq.
Of Counsel
K&L Gates LLP
• ICH-Q7A
(3 or 4 digit code)
course id# 2091
Recommended
Reading
Past Participants
Have Said:
• INDs, NDAs vs CTDs Global Regulations
The Center for Professional Advancement
course id# 448
Course Director
Additional Faculty
The Center for Professional Advancement
has been approved as an Authorized
Courses
of Interest
Provider by the International Association for
course id# 840 First
• Excipient GMPs
Credit card billing address (if different than above address)
ID 1462
Accreditations
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Since our founding in 1967, we have successfully trained nearly a half
Director
million people worldwideCourse
in topics ranging
from basic and introductory
concepts to new advances and cutting-edge technology, and current
U.S. and European regulations. CfPA courses are offered in a variety
of formats – Public offering, Client Site and Online – to fit you or your
company’s training needs.
Additional Faculty
course id# 1989
Exp. Date
(As appears on card)
Course&Co-Directors
Pay by Feb 7
SAVE $200- Register
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P.O. Box 7077, East Brunswick, NJ 08816-7077
Phone: 732.238.1600 • Fax: 732.238.9113
E-mail: info@cfpa.com
3 Ways To Register
• Scale-Up and Post Approval Changes Guidelines
(SUPAC & API Changes)
C0-172
course id# 1948
First Day
www.cfpa.com
Second Day
www.cfpa.com
Course Objectives
Location
Learning
Who Should Attend
Course
Director
Course
Description
This overview course
is intended
for personnel from generic
and brand name drug manufacturers and bulk drug substance
Learning
Objectives
suppliers who seek
a broad and
thorough understanding of
the legal, regulatory,
and
practical
aspects of developing and
Additional
Faculty
Who We Are
compiling Abbreviated New Drug Applications (ANDAs) and
obtaining FDA approval
of generic
drugs, including:
Course
Description
• Regulatory Affairs
• Technical/Scientific/Research
CourseText
Location
• QA/QC
• Management
Who Should
Attend
• Legal/Compliance
• Manufacturing
Who We Are
Day
CourseFirst
Director
Learning Objectives
Course Location
Upon completion of this course,
you
ThirdFaculty
Daywill be able to:
Additional
• Describe the basic
requirements
for preparing an ANDA
Course
Description
Course
Director
and the legal foundation
for those
requirements
• Organize and coordinate Text
corporate activities related to
ANDAs Past Participants
Have Said:
Who We Are
Additional Faculty
• File a paper or electronic ANDA (CTD) with FDA
First Day
• Manage the process
obtaining
approval from FDA
WhoofShould
Attend
Course Location
• Respond to problems in the
ANDA identified by FDA
Text
• Address changes or other
concerns
Third
Day that arise after
Learning
Objectives
approval
Course Director
First Day
Course Description
Past Participants
Have Said:
Additional Faculty
Third Day
Third Day
This course will review the basic provisions of the WaxmanHatch Act; the information and data required for an ANDA;
which drugs are eligible
for submission
under an ANDA and
Additional
Faculty
why; the role of patent protection and market exclusivity;
Past Participants
Have
pitfalls and pointers
in dealing with the
FDASaid:
review process;
bioequivalence testing; and changing pending ANDAs and
Text attention will be given in
Drug Master Files (DMFs). Particular
the course to the impact of FDA's regulations and guidances
on both paper and electronic ANDAs.
First Day
Third Day
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COURSE OUTLINE
Course Co-Directors
Who We Are
Generic Drug ApprovalsAccreditations
3 Ways Information
To Additional
Register Faculty
General
Second Esq.
Day is General Counsel & Vice
Robert J. Anderson,
President, Regulatory Affairs at Nycomed US Inc., a leading
manufacturer ofRecommended
multi-source topicalReading
products. He has over 15
years of experience
regulatory and legal affairs, patent law,
FourthinDay
pharmaceutical research and development, clinical research
and quality assurance. Mr. Anderson received his B.S. from
3 Ways To Register
Northwestern University (Neurobiology & Physiology) and a
J.D.
from the
Second
DayJohn Marshall Law School.
First Day
April 4–6, 2011 • New Brunswick, NJ | Offering# 1104-205
Course Location
Courses of Interest
• Pioneer Companies’ Duty to File Patent
Second
Text with
Third Day
First Day Course Co-Directors
Information
FDA Day
• The ANDA Applicant’s Duty to File
Course Director
General Information
Patent Certifications
8:00 a.m.: Registration/Continental
8:30–10:15 a.m.:
Breakfast
• The Importance
of Patent
Day Certification
First Day Fourth
Third Day Recommended Reading
• Patent Challenges and Paragraph IV
How to Format and File an Electronic
ANDA
Accreditations
Certifications
8:30–10:00 a.m.:
Additional Faculty
Course Co-Directors
• Effect on Approval Time Frames
Introduction to the Legal Basis for
10:30–12:30 p.m.:
•
Patent
Extension
Eligibility
Abbreviated New Drug
Third
SecondDay
Day
3 Ways To Register
How to Format and File an Electronic
Applications/Review of Learning
Courses of Interest
Objectives:
Text Bioequivalence Submission
Recommended Reading
• Federal Food, Drug, and Cosmetic Act
Fourth Day
Second Day
of 1938
First Day
1:30–3:00 p.m.:
PastInformation
Participants Have Said:
• Drug Amendments of 1962 General
Drug Master Files (DMFs), Bulk
First Day
3 Ways To Register
• FDA Modernization Act of 1997
Pharmaceutical Chemicals (BPCs) and
8:30–10:00 a.m.:
• Medicare Modernization Act of 2003
Activities Triggered by an ANDA Filing:
Patent Terms and 180-Day Exclusivity:
Fourth
Day
Day Drugs
• DESI Review Third
and Generic
• Filing of DMF
•
R&D
Safe
Harbor
• Paper [505(b)(2)] NDA Policy Course Co-Directors
• DMF as Part of ANDA
Third Day
• Forfeiture of 180-Day
Exclusivity
Second
Day
First
Day
• FDA Amendments Act of 2007
• Dealing with Your Bulk Drug Supplier
• 180-day Exclusivity for ANDAs with
• Auditing Your Supplier
Second
Day
Patent
Challenge
Accreditations
10:30–12:00 noon:
• Pitfalls in Sourcing
•
Related
Case
Law,
Regulations
and
Recommended
Reading
Overview of the Waxman-Hatch
Act:
• Post-Submission Amendments to
Fourth Day
Policies
Third Day
ANDAs;
• A Response to the Unavailability of
Past
Participants
Have
Said:
Fourth Day
•
Post Approval Changes (SUPAC) to
Generic Versions of Post-1962Courses
Drugs
10:30–12:00
noon:
of
Interest
ANDAs;
• Requirements of ANDAs under3Section
The Format and Content of an ANDA:
Ways To Register
Second Day
• Other Post-Marketing Requirements
505(j) of the Act
• How to Make Sure Your ANDA is Both
• The Concept of "Listed" Drugs
Intelligible and Organized—Tips and
• ANDA Suitability Petitions for General
Variations Information
Assessment Opportunity
Caveats
Second
Day
of an ApprovedFirst
DrugDay
• TheFourth
Waxman-Hatch
Day Act Provisions and
Related Regulations
1:00–2:30 p.m.:
• The Chemistry, Manufacturing and
Bioequivalence/Bioavailability: Course Co-Directors
Controls (CMC)
Section
Fourth
Day
Third Day
• Solid Oral Dosage Studies
• Other Submission Obligations
• Non-Systemically Absorbed Products—
• Verifying the Accuracy of Data for the
Inhalers and Topicals
ANDA
Recommended Reading
• Waivers of Bioequivalence Studies
Second Day
• Guidances; Cross-Over Design; New
1:00–3:00 p.m.:
Study Designs
The Format and Content of an ANDA
(continued)
3 Ways To Register
Fourth Day
3:00–5:15 p.m.:
Patent Terms, and Certifications under
3:30–5:00 p.m.:
the Waxman-Hatch Act:
The Format and Content of an ANDA
Second Day
First Dayand Generic
(continued)
• Intersection of Patents
Drug Approvals
Third Day
Client Site
Fourth Day
Second Day
Training at your site and at your convenience. For further information,
please contact Client Site Programs: Direct Dial (USA) +1/732.238.1600,
ext. 4547; or fax +1/732.238.9113; or E-mail clientsite@cfpa.com.
Fourth Day
www.cfpa.com
Online Training Now Available
A convenient and cost-effective way to experience our accredited
training, easily access the knowledge you need through the Internet. For
a list of upcoming courses visit www.cfpa.com/online-training.
Gary L. Yingling, Esq. is a Partner with the law firm of K&L
FirstLLP.
DayPrior to
Gates
entering
private
practice he was,Second
for nineDay
Who
Should
Attend
years,
President
of
the
Food
and
Drug
Law
Institute.
Mr.
Fourth Day
Yingling served in government for ten years, primarily in FDA’s
Office
General Counsel as a trial attorney and, later,
as Day
Fourth
ThirdofDay
Learning
Objectives
Associate Chief Counsel
for Veterinary
Medicine and Deputy
Chief Counsel for Administration. He also served as Director
of FDA’s Over-the-Counter Drug Review. Mr. Yingling received
Day
his B.S. in Pharmacy from the UniversitySecond
Course Descriptionof North Carolina,
an M.S. in Pharmacology from Purdue University, and his
law degree from Emory University.
Rebecca L. Dandeker, Esq. is Of Counsel
to the Day
Washington
Fourth
Who
D.C. office of K&LGates
LLP.We
HerAre
practice involves legal and
regulatory counseling in the areas of pharmaceuticals, dietary
supplements, cosmetics and alternative therapies. Ms.
Dandeker routinely advises on drug approval strategy,
Course Location
compliance issues and enforcement actions. She also
challenges FDA policies via informal correspondence, citizen
petitions and litigation. Ms. Dandeker has a J.D. from
Georgetown University
Law Center
and a B.S. from Liberty
Course
Director
University.
Who Should Attend
Additional Faculty
Candis B. Edwards
is currently
Sr. Vice President, Regulatory
Learning
Objectives
Affairs & Compliance for Amneal Pharmaceuticals LLC, a
Textof generic pharmaceuticals.
New York-based manufacturer
Ms. Edwards has over 25 years of experience in Regulatory
Description
Affairs, ResearchCourse
and Development,
Project Management,
Quality Assurance, cGMP First
Compliance
Day and Quality Control.
© The Center for Professional Advancement 2011
When Congress passed the Drug Price Competition and
Patent Term Restoration Act of 1984 (the “Waxman-Hatch
Who We Areindustry to seek approval
Act”), it enabled the pharmaceutical
Text
via an ANDA of generic versions of the vast majority of drugs
approved byPast
FDA since
1962. New,Have
complex
requirements
Participants
Said:
were imposed on persons
seeking
FDA
approval
of these
Course Location
generic drugs. Congress also
created
First
Dayincentives to
encourage development of new branded products, including
extended patent protection and periods of non-patent market
Course Director
exclusivity.
Course
Director
Recommended
Reading
Courses of Interest
She is currently an Associate Professor in the graduate
degree program at St. John's
University
Who We
Are College of Pharmacy
and Allied Health Professions.
Third Day
Course Location
This course will be held in the New Brunswick, New Jersey
Past Participants Have Said:
area. Specific hotel information will be sent to you in your final
Course Director
confirmation package which will be emailed to you
approximately four (4) weeks prior to the course start date.
Please note that participants must make their own hotel
reservations; the cost
of the hotel
accommodations is not
Additional
Faculty
included in the course fee.
Text