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The Globalization of Risk Management
Session Chair(s)
Jamie Wilkins, PHARMD
Head, Risk Management Center of Excellence
Pfizer Inc, United States
This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.
Learning Objective : Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.
Speaker(s)
Recent FDA Risk Management Guidance for Industry- REMS Logic Model
Claudia Manzo, PHARMD
AbbVie, United States
Head of the Office of Risk Management, Pharmacovigilance and Patient Safety
Recent EMA Risk Management Initiatives- GVP XVI r3
Priya Bahri, PHD, RPH
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
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