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Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities
Session Chair(s)
Nina S. Cauchon, PHD
Director Regulatory Affairs CMC, Amgen, United States
The pace of innovation in the pharmaceutical industry has accelerated tremendously. Future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization and industry efforts. This session will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval.
Learning Objective : Discuss the landscape for innovative modalities and emerging technologies in the field of human therapeutics; Describe the regulatory CMC challenges associated with their product development and approval.
Speaker(s)
Regulating Innovation in CMC – A Perspective from Industry
Director Regulatory Affairs CMC, Amgen, United States
Integrated Manufacturing and its Opportunities to Low Cost Vaccine Manufacture
Professor; Member, Koch Institute for Integrative Cancer Research, Koch Institute At MIT, United States
Regulating Advanced Therapy: Gene and Cell Therapy Products
Director, Division of Cellular and Gene Therapies, OTAT, CBER, FDA, United States
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