Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 4: Definitions and Concepts for Drug Safety

Session Chair(s)

JP Clement, MD

Founder and Principal

JPCC Associates, United States

This session will clarify important concepts, terms, and regulatory expectations in the context of interventional clinical trials and in the post-marketing setting. International consensus terms and definitions will be discussed, particularly those relevant to the US and EU.

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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 4: Definitions and Concepts for Drug Safety

Session Chair(s)

JP Clement, MD

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