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CfPA-The Center for Professional Advancement, New Brunswick, NJ
November 16-18, 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
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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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| 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.
Additional Faculty
Amy M. Byrom, Director of Regulatory Affairs,Fougera Pharmaceuticals, Inc.
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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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jmorbit@cfpa.com
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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.