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Sheraton Boston Hotel

16 ago 2017 8:00 a.m. - 17 ago 2017 5:15 p.m.

39 Dalton Street, , Boston, MA 02119 , USA

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

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Session 3: The New Pharmacovigilance Regulations

Session Chair(s)

Diptee A. Gajjar, PhD

Intercontinental Regulatory Strategy Lead

Bristol-Myers Squibb Company, United States

Pharmacovigilance assessment procedures and interactions with committees
Pharmacovigilance System Master File
Risk management plan
Periodic Safety Update Report (PSUR)
Changes to Summary of Product Characteristics (SmPC) and Package Leaflet (PL)
Transparency and information

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