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Generic Drug Approvals

  December 13, 2010  
CfPA - The Center for Professional Advancement, New Brunswick, NJ
April 4-6, 2011

Who Should Attend
This overview course is intended for personnel from generic and brand name drug manufacturers and bulk drug substance suppliers who seek a broad and thorough understanding of the legal, regulatory, and practical aspects of developing and compiling Abbreviated New Drug Applications (ANDAs) and obtaining FDA approval of generic drugs, including:

  • Regulatory Affairs 
  • Technical/Scientific/Research
  • QA/QC 
  • Management
  • Legal/Compliance 
  • Manufacturing

When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Waxman-Hatch Act”), it enabled the pharmaceutical industry to seek approval via an ANDA of generic versions of the vast majority of drugs approved by FDA since 1962. New, complex requirements were imposed on persons seeking FDA approval of these generic drugs. Congress also created incentives to encourage development of new branded products, including extended patent protection and periods of non-patent market exclusivity.

This course will review the basic provisions of the Waxman- Hatch Act; the information and data required for an ANDA; which drugs are eligible for submission under an ANDA and why; the role of patent protection and market exclusivity; pitfalls and pointers in dealing with the FDA review process; bioequivalence testing; and changing pending ANDAs and Drug Master Files (DMFs). Particular attention will be given in the course to the impact of FDA's regulations and guidances on both paper and electronic ANDAs.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Robert J. Anderson, Esq.; General Counsel & Vice President, Regulatory Affairs, Nycomed US Inc.

Robert J. Anderson, Esq. is General Counsel & Vice President, Regulatory Affairs at Nycomed US Inc., a leading manufacturer of multi-source topical products. He has over 15 years of experience in regulatory and legal affairs, patent law, pharmaceutical research and development, clinical research and quality assurance. Mr. Anderson received his B.S. from Northwestern University (Neurobiology & Physiology) and a J.D. from the John Marshall Law School.

Gary L. Yingling, Esq.; Partner, K&L Gates LLP

Gary L. Yingling, Esq. is a Partner with the law firm of K&L Gates LLP. Prior to entering private practice he was, for nine years, President of the Food and Drug Law Institute. Mr. Yingling served in government for ten years, primarily in FDA’s Office of General Counsel as a trial attorney and, later, as 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 his B.S. in Pharmacy from the University of North Carolina, an M.S. in Pharmacology from Purdue University, and his law degree from Emory University.

Rebecca L. Dandeker, Esq.; Of Counsel, K&L Gates LLP

Rebecca L. Dandeker, Esq. is Of Counsel to the Washington D.C. office of K&LGates LLP. Her 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, 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 University.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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