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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
BD Medical - Diabetes Care, United States
Worldwide Director, Regulatory Affairs
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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