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Integrating Safety, Regulatory, and Benefit-Risk Functions to Enhance Compliance & Efficiency in Maintaining Marketed Products

Presenters

Libbie Parker McKenzie, MD

Libbie Parker McKenzie, MD

VP Lifecycle Safety Mgmt; Global Head, Safety Surveillance and Benefit-Risk Mgmt, Quintiles Transnational Corp. , United States

Dr. McKenzie is Vice President and Global Head of Marketed Product Safety Services at Quintiles and serves as one of the governing heads of its Lifecycle Safety organization. She oversees teams providing QPPV services, Medical Information, Safety Aggregate Reporting, Signal Detection, and Risk Management Planning. She previouly managed Quintiles Global Medical Safety Advisor team, focusing on safety profile management. She is a board certified nephrologist and maintains a limited practice.

Simon  Ashworth, MD

Simon Ashworth, MD

EU QPPV and Global Medical Safety Head - Established Products, Takeda Development Centre Europe Ltd., United Kingdom

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