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Published byBrooke Quinn Modified over 9 years ago
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FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation
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Background to Industry Representative Introduced in FDA Modernization Act Non-voting member, non–SGE – Financial interest disclosure Conflict of interest? – Personal example
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Process for Nomination Federal Register notice published Industry organizations interested send a letter within 30 days FDA requests organizations to consult in selecting candidate (if more than 1 identified) Single nominee provided to FDA within 60 days
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How is the Industry Rep. Selected? Industry Associations poll members for nominees Nominees are reviewed by appropriate committee e.g. PhRMA RACC – Education, knowledge in subject, industry experience Industry Associations agree on a single nominee Nominee details sent to FDA
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What is the role of the Industry Rep.? Represents global concerns for industry (not their own company) Provide industry perspective to discussions e.g. cost or practical application of a proposal, regulatory standards Speak with industry &/or sponsor before meeting to ensure appropriate representation
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