Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other...
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Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada
Catherine Parker Director of the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate of Health CanadaHer Office has overall responsibility for all policy and regulatory development respecting biologic drugs. She played a key role...
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Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and...
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Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he...
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Technical Officer, Regulatory Networks and Harmonization Team, World Health Organization (WHO)
Gabriela Zenhausern has worked for Swissmedic before joining WHO in December 2015. As a technical officer in the Regulatory Systems Strengthening Team (RSS), she provides support to various regulatory harmonization initiatives and regulatory networks in different WHO regions. Gabriela...
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