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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 3: The New Pharmacovigilance Regulations

Session Chair(s)

Diptee A. Gajjar, PhD

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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