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Session 6 Track 2 - Reg Ops Optimization/Lessons Learned
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
Outline and explore practical advice and tools to help plan, prepare, and manage global regulatory submissions. Seasoned professionals will share their experience from both the sponsor side as well as the vendor side so that participants can avoid pitfalls and make better decisions in the regulatory operations space. Specifically, we will discuss the implications for granularity, life cycle, and attribute decisions. We will outline how to prepare for new business processes and leverage technology in a global submission management group.
Speaker(s)
Lessons Learned: A Vendor’s Perspective on Regulatory Submissions
Adair Turner, MSC, RAC
Cencora Pharmalex, United States
Sr. Director, Head of Regulatory Affairs US
If I Knew Then What I Know Now - Lessons Learned From a Decade of Global Submissions
Carrie Mazrillo
Eisai, Inc., United States
Submissions Manager, Global Regulatory Affairs
Speaker
Matthew Millstein
Sanofi, United States
Global Regulatory Team Lead