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Session 5: Safety Management Considerations for Advanced Therapeutics
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer , Bristol Myers Squibb, United States
Session 5: Safety Management Considerations for Advanced Therapeutics
Learning Objective : In this session you will hear experiences, insights, and perspectives from those working in this field.
- Identify specific challenges for adequate safety monitoring for advanced therapeutics
- Gain insights on how to improve your acumen on advanced therapies for your everyday work
Speaker(s)
Kasia Lobello, MD
Safety Risk Lead, Pfizer Inc., United States
Gene Therapy for Duchenne Muscular Dystrophy: Lessons learned (so far) from the fordadistrogene movaparvovec clinical trial program
Emil Andrei Cochino, MD, MHS
Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands
Safety Management Considerations for Advanced Therapeutics
Robert Sokolic, MD, FACP
Medical Officer, Food and Drug Administration, United States
Speakers
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