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Sheraton Boston Hotel

Aug 16, 2017 8:00 AM - Aug 17, 2017 5:15 PM

39 Dalton Street, , Boston, MA 02119 , USA

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

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Session 2: The Role of Regulatory Affairs During Drug Development

Session Chair(s)

Diptee A. Gajjar, PhD

Intercontinental Regulatory Strategy Lead

Bristol-Myers Squibb Company, United States

Phases of Drug development/lifecycle of medicines
Scientific advice
Clinical trials
Pediatric regulation
Orphan regulation
Good regulatory practices - Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)

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