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Generic Drug Approvals

 
  October 08, 2015  
     
 
CfPA-The Center for Professional Advancement, Burlingame, CA
February 9-11, 2016


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

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman 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, as well as incentives for generic firms to challenge branded patents.

This course will review the basic provisions of the Hatch-Waxman 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:
Michael A. Swit, Esq.; Senior Director, Legal, Regulatory, Illumina

Michael Swit, Senior Director, Legal, Regulatory for Illumina, has been addressing critical FDA legal and regulatory issues since 1984. A former special counsel with Duane Morris LLP, he previously served as a VP for The Weinberg Group, where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences, food, cosmetic and dietary supplement industries.

Mr. Swit is a former member of the board of directors of the National Organization for Rare Disorders (NORD. He has taught and written on FDA law, regulation and related commercial activities. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit has been a prominent speaker at such organizations as RAPS, FDLI, and DIA.

A magna cum laude graduate of Bowdoin College, with high honors in history, Mr. Swit received his law degree from Emory University School of Law. He is a member of the California Bar.

 

Robert J. Anderson, Esq.; Founder, ARC Regulatory Consulting

Robert J. Anderson, Esq. is the founder of ARC Regulatory Consulting, a legal & regulatory resource for the pharmaceutical and biotech industry. Mr. Anderson was previously the General Counsel & Vice President, Regulatory Affairs at Nycomed US Inc., a leading manufacturer of multi-source topical products. He has over 20 years of experience in regulatory and legal affairs, patent law, pharmaceutical research and development, clinical research and quality assurance, and negotiated FDA approval of more than 150 ANDAs. Mr. Anderson received his B.S. from Northwestern University (Neurobiology & Physiology) and a J.D. from the John Marshall Law School.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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