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Session 5: Safety Management Considerations for Advanced Therapeutics
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, 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)
Gene Therapy for Duchenne Muscular Dystrophy: Lessons learned (so far) from the fordadistrogene movaparvovec clinical trial program
Kasia Lobello, MD
Pfizer Inc., United States
Safety Risk Lead
Safety Management Considerations for Advanced Therapeutics
Emil Andrei Cochino, MD, MHS
European Medicines Agency, Netherlands
Scientific Senior Specialist (Risk Management)
Speakers
Robert Sokolic, MD, FACP
Food and Drug Administration, United States
Medical Officer