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The Center for Professional Advancement, New Brunswick, NJ
May 14-16, 2008
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
Description
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.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Robert J. Anderson, Esq.; Vice President, Scientific Affairs, Nycomed
Robert J. Anderson, Esq., is Vice President, Scientific Affairs at Nycomed, 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.
Michael A. Swit, Esq.; Vice President Life Sciences, The Weinberg Group Inc.
Michael A. Swit, Esq., is Vice President, Life Sciences at The Weinberg Group Inc., a premier scientific and regulatory consulting firm in the Life Sciences. Since 1984 he has been both in private practice with McKenna & Cuneo and Heller Ehrman, and as Vice President, General Counsel and Secretary of Par Pharmaceutical. He also served from 1994 to 1998 as CEO of FDANews.com.
Gary L. Yingling, Esq.; Partner, Kirkpatrick & Lockhart Preston Gates Ellis, LLP
Gary L. Yingling, Esq. is a Partner with the law firm of Kirkpatrick & Lockhart Preston Gates Ellis LLP. Mr. Yingling served in FDA’s Office of General Counsel as a trial attorney, as Associate Chief Counsel for Veterinary Medicine, Deputy Chief Counsel for Administration and as Director of FDA’s Over-the-Counter Drug Review. He is counsel to the International Society for Regulatory Toxicology and Pharmacology, is Editor of the Guide to Good Clinical Practices,and serves on the Editorial Board of both the Clinical Research Practices and Drug Regulatory Affairs and Regulatory Toxicology and Pharmacology journals.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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