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Session 1: Premarket Considerations
Session Chair(s)
Valerie Fenster
Senior Manager, Human Factors Engineering, Device Technologies
Amgen Inc., United States
Speaker(s)
Human Factors: A Case Study Driven Discussion of What Human Factors Studies Are, When They Are Needed, and How to Conduct Them Successfully for Combination Products
Kathleen E. O'Sullivan, MS, RAC
BAYER, United States
DIRECTOR REGULATORY STRATEGY
Raza Ahmed, MD
BD Medical- Pharmaceutical Systems, United States
Worldwide Director, Medical Affairs, Self Administration Injection Systems
Redefining Focus: Lessons Learned in Transitioning from a Biologics to a Combination Products Company
Dave Anderson
AstraZeneca Biologics (MedImmune), United States
Associate Director Quality for Combination Products
Lessons Learned: Tips for Sponsors to Navigate the Premarket Authorization for Combination Products
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
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