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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Implementing Regulatory Outsourcing Partnerships: New Trends and Practices

Session Chair(s)

Tracy  Tsuetaki, MBA, MS

Tracy Tsuetaki, MBA, MS

Group President, Life Sciences

OptumInsight, United States

This forum will present examples of regulatory outsourcing partnerships and discuss trends in this area. A panel of experts will provide their interpretation of data from results of a global regulatory outsourcing survey and share best practices.

Learning Objective : Discuss examples of regulatory outsourcing partnerships and review regulatory partnership agreements for their respective benefits to their organizations; Describe best practices from a regulatory outsourcing survey.

Speaker(s)

Tracy  Tsuetaki, MBA, MS

Survey of Regulatory Outsourcing Trends

Tracy Tsuetaki, MBA, MS

OptumInsight, United States

Group President, Life Sciences

Pamela M. Williamson, MBA, RAC

Regulatory Offshoring, Nearshoring and Homeshoring: Is It Smartsourcing?

Pamela M. Williamson, MBA, RAC

Genzyme Corporation, A Sanofi Company, United States

Senior Vice President, Global Head, Regulatory Affairs and Compliance

Andrew  Storey

Maximizing Value of Outsourcing

Andrew Storey

AbbVie, United States

Vice President, Regulatory Affairs United States and Canada

Sean  Darcy, BSN, RN

Management and Oversight of Outsourcing Services for Patient Safety and Medical Information

Sean Darcy, BSN, RN

Vertex Pharmaceuticals, United States

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