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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)
Adair Turner, MSC, RAC
Sr. Director, Head of Regulatory Affairs US, Cencora Pharmalex, United States
Lessons Learned: A Vendor’s Perspective on Regulatory Submissions
Carrie Mazrillo
Submissions Manager, Global Regulatory Affairs, Eisai, Inc., United States
If I Knew Then What I Know Now - Lessons Learned From a Decade of Global Submissions
Matthew Millstein
Global Regulatory Team Lead, Sanofi, United States
Speaker
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