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Session 18: Postmarketing Safety Regulations – EU
Session Chair(s)
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will provide an introductory orientation to the changing postmarketing safety requirements in the EEA, with a focus on Good Pharmacovigilance Practice (GVP).
- EU Postmarketing Safety Regulations and Directives
- Commission Implementing Regulation No. 520/2012 of 19 Jun 2012
- EU GVP Modules 1-16
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