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Sheraton Philadelphia Downtown Hotel

2015 年 05 月 11 日 1:00 下午 - 2015 年 05 月 13 日 5:00 下午

201 North 17th Street, Philadelphia, PA 19103

eRegulatory and Intelligence Annual Conference

Session 6 Track 1: Regulatory Operations Outsourcing - Recipe for Success

Session Chair(s)

Dominique  Lagrave, PharmD

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)

Meghan  Mendoza, MBA, RAC

Speaker

Meghan Mendoza, MBA, RAC

Amgen, Inc., United States

Senior Manager, Regulatory Operations

Abhinav  Gupta

Speaker

Abhinav Gupta

TCS, United States

Ast General Manager Client Relations

Emily  Onkka

Speaker

Emily Onkka

Pfenex, Inc., United States

Senior Director, Regulatory Affairs

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