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Session 4 Track 1 - Managing and Developing Regulatory Submission Operations
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
Ensuring success in regulatory submission operations requires a diverse set of technical and business skills. As a result, the regulatory operations space has evolved into a respected professional career and function critical to product registrations. This session will explore managing the developing global regulatory operations groups from several perspectives including hiring and training staff, vendor evaluation, and budget requirements.
Speaker(s)
Analysis and Decision Making for Establishing and Growing a Global Reg Ops Group
Robert Connelly, MBA
Incyte, United States
Senior Director, Global Regulatory Operations
Global Regulatory Operations for a CRO – Opportunity in the Paradigm
Eric W. Vestal, MA, MS, PMP
Clinipace Worldwide, United States
Sr Director, Global Reg Ops Process & Technology; Reg Strategic Development
A Sponsor’s Case Study on Efficient Regulatory Operations
Muriel L. Spooner, RAC
Muriel Spooner Consulting, United States
Principal/ Consultant
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