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Ginette Michaud
Director, Office of Biological Products Operations at FDA, USA

Profile

Dr. Michaud is a hematologist with twenty-two years of FDA experience in the regulation of biological products and medical devices. She joined the Office of Regulatory Affairs (ORA) in 2016, and in May 2017, Dr. Michaud became the Director, Office of Biological Products Operations. Prior to joining ORA, Dr. Michaud held various management positions in FDA, first in the Center for Devices and Radiological health, and more recently, in the Center for Biologics Evaluation and Research where she served as Deputy Director, Office of Blood Research and Review.

During her career at FDA, Dr. Michaud has been engaged in international regulatory capacity building, global regulatory harmonization and in the development of technical standards and reference materials. She currently represents ORA as a participant in the Pharmaceutical Inspection Co-operation Scheme.

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Agenda Sessions

  • Breakfast Surgery – FDA, EMA and PMDA Pinch Points

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  • Breakfast Surgery – FDA, EMA and PMDA Pinch Points

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  • Breakfast Surgery – FDA, EMA and PMDA Pinch Points

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Speakers at this event