Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 23: EU Landscape (continued)

Session Chair(s)

JP Clement, MD

Founder and Principal

JPCC Associates, United States

This session will continue discussion of the post-marketing setting in the EEA, with additional details on quality-assured pharmacovigilance systems, e.g., the Pharmacovigilance System Master File (PSMF), the role of the EU Qualified Person for Pharmacovigilance (QPPV), and EMA’s Medical Literature Monitoring (MLM) service.

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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 23: EU Landscape (continued)

Session Chair(s)

JP Clement, MD

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