Safety Risk Communication for Medical Products

In this virtual training course, learn how to enhance the effectiveness of safety risk communication in light of evolving regulatory expectations.

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Session 7: Risk Communication and Risk Management in the US and EU

Session Chair(s)

Meredith Smith, PhD, MPA, FISPE

Senior Director, Implementation Science Pillar Lead

Evidera, Inc, United States

This session will compare and contrast the approaches taken by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in regard to risk communication and risk management for medicinal products. Specific topics covered will include the purpose and structure of Risk Evaluation and Mitigation Strategies (REMS) in the US and the elements of the EU Risk Management Plan. Participants will be introduced to new developments, including the FDA’s Benefit-Risk Counseling Framework for REMS and efforts in the EU to enhance the Patient Information Leaflet (PIL).