Spring Intro 2023

16/02/2023

Lifecycle Management – Safety & Efficacy

Kay Martin, Associate Director European, Canada & Partner Market Regulatory Sciences , Biogen

Disclaimer: Content reflects personal views

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Learning outcomes Understand EU Regulatory lifecycle management :

Risk/benefit assessment: • Conditional Marketing Authorisation (MA) • Renewals • Post-approval measures • Paediatric Investigation Plan (PIP) maintenance activities Maintaining Compliance: • Sunset clause monitoring • GxP Inspections • Pharmacovigilance System Master File (PSMF)

Exanding Opportunities • Efficacy variations

Minimising Risks: • Safety variations

• Periodic Safety Update Reports (PSURs) • Risk Management Plan (RMP) incl. Direct Healthcare Professional Communications (DHPCs) & Educational tools

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