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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 6 Track 2 - Reg Ops Optimization/Lessons Learned

Session Chair(s)

Christian A. Buckley, MBA, RAC

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.


Adair  Turner, MSc, RAC

Lessons Learned: A Vendor’s Perspective on Regulatory Submissions

Adair Turner, MSc, RAC

Cencora Pharmalex, United States

Sr. Director, Head of Regulatory Affairs US

Carrie  Mazrillo

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

Matthew  Millstein


Matthew Millstein

Sanofi, United States

Global Regulatory Team Lead

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