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Session 6 Track 1: Regulatory Operations Outsourcing - Recipe for Success
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States
The approach taken by a large and small biotech company towards implementing successful regulatory operations outsourcing will be explored. We will learn the various steps in the set up and management of such initiatives to ensure the best outcome. We will also hear the perspective from a vendor on what to consider to make a true partnership for success. Each speaker will provide case studies.
Speaker(s)
Speaker
Meghan Mendoza, MBA, RAC
Amgen, Inc., United States
Senior Manager, Regulatory Operations
Speaker
Abhinav Gupta
TCS, United States
Ast General Manager Client Relations
Speaker
Emily Onkka
Pfenex, Inc., United States
Senior Director, Regulatory Affairs
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