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Session 1: US and EU Combination Products Regulatory Updates
Session Chair(s)
Steven B. Binion
Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
Becton Dickinson, United States
In recent months, regulatory authorities have made numerous changes aimed at clarifying the complexities of combination product requirements. In this session, US and EU regulators will discuss the most recent and pending updates on guidances and rules for combination product review and life cycle management.
Speaker(s)
Speaker
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Speaker
Elizabeth Baker
Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom
Group Manager Licensing Division
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