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Session 7: Roundtable Discussions
Session Chair(s)
Dave Anderson
Associate Director Quality for Combination Products
AstraZeneca Biologics (MedImmune), United States
This session will be a highly interactive activity with several tables of 5-10 participants actively discussing a timely topic of interest, followed by a brief summary report out from each table at the end of the session. A subject matter expert will be assigned to each table to guide the discussion, and special focus will be on experiences and lessons learned.
Speaker(s)
Pediatric Indications and PREA Requirements
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
Total Product Life Cycle: Life Cycle Management of Combination Products
Winifred Wu, MBA
Strategic Regulatory Partners, LLC, United States
President and Principal Advisor
Risk Management for Combination Products
Kathleen E. O'Sullivan, MS, RAC
BD Medical - Diabetes Care, United States
Worldwide Director, Regulatory Affairs
Combination Therapies
Dave Anderson
AstraZeneca Biologics (MedImmune), United States
Associate Director Quality for Combination Products
Generic/Biosimilars in Combination Products
Willy Liou, MS, RAC
Amgen, Inc., United States
Manager, Regulatory Affairs
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