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Sheraton Boston Hotel

2017 年 08 月 16 日 8:00 上午 - 2017 年 08 月 17 日 5:15 下午

39 Dalton Street, , Boston, MA 02119 , USA

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

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Session 4: Registration Dossier

Session Chair(s)

Diptee A. Gajjar, PhD

Intercontinental Regulatory Strategy Lead

Bristol-Myers Squibb Company, United States

Format: CTD
Introduction to the CTD structure
Administrative information in EU module 1
Electronic submission; eCTD