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Mwango Kashoki, MD, MPH

SVP, Global Head of Regulatory Strategy
Parexel International

Dr. Mwango Kashoki, MD, MPH, is a SVP and the Global Head of Regulatory Strategy at Parexel International, one of the largest CROs in the world. Dr. Kashoki brings more than 20 years of drug development experience to this role, including over 16 years of U.S. Food and Drug Administration (FDA) regulatory experience with increasing senior positions. In her last FDA role, she developed and had oversight over the full span of postmarket drug safety policies and procedures in CDER's Office of New Drugs (OND). She co-authored draft FDA guidances and CDER policies on postmarket drug safety. She also served as a Senior Advisor to the OND Director and review divisions on complex and broad drug safety issues and strategic initiatives. As Parexel's Global Head of Regulatory Strategy, she supports companies with formulating and implementing innovative and efficient product development plans, as well as regulatory strategies, across all phases of development and across multiple therapeutic areas. She provides strategic leadership for Parexel’s global Regulatory Consulting business, leading the organization’s work to deliver ieffective solutions to companies that enable them to navigate regulatory authority requirements and advance their medical product development.

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