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CfPA-The Center for Professional Advancement, New Brunswick, NJ
May 5-7, 2015
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 “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.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Michael A. Swit, Esq.; Special Counsel, Duane Morris LLP
Michael A. Swit, Esq. is a Special Counsel in the San Diego office of the global firm, Duane Morris LLP. Swit has 29 years’ experience in addressing FDA legal and regulatory challenges, with particular expertise in the generic drug approval process. A founding director of this course in 1989, Mr. Swit also is past general counsel of Par Pharmaceutical, a major generic drug manufacturer. He received his A.B., magna cum laude, with high honors in history, from Bowdoin College and his law degree from Emory University. A regular speaker at FDArelated educational activities, he also is a past member of the editorial board of the Food & Drug Law Journal.
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 multisource 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.
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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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sberg@cfpa.com
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