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Virtual Training Course (US Eastern Time)

Oct 19, 2020 9:00 AM - Oct 23, 2020 1:45 PM

Regulatory Affairs: The IND, NDA, and Post-Marketing

Faculty

Elliott  Berger, PhD, MS

Elliott Berger, PhD, MS

President, ETB Regualtory Consulting, United States

Elliott T. Berger, PhD, is President of ETB Regulatory Consulting, LLC. He recently retired from BioCryst Pharmaceuticals, Inc., where he held the position of Senior Vice President of Regulatory Affairs for 14 years. He has frequently served as speaker and session chair at numerous meetings and workshops for DIA and for the Pharmaceutical Research & Manufacturers of America (PhRMA). He serves as an instructor for the DIA Regulatory Affairs: The IND, NDA, and Post-Marketing training course and is a member of the DIA Regulatory Training Committee.

Kevin Daniel Healy, PhD

Kevin Daniel Healy, PhD

Senior Vice President Regulatory Affairs, Entrada Therapeutics, United States

Dr. Kevin Healy is Senior Vice President of Regulatory Affairs at Entrada and is a member of the senior leadership team and responsible for developing and executing global regulatory strategies to advance Entrada’s pipeline. Kevin has extensive expertise in the development and commercialization of therapies for serious and rare diseases and has led or participated in more than 30 formal meetings. Prior to joining Entrada, Kevin oversaw Regulatory Affairs and other biotech-enabling functions, including Quality, Pharmacovigilance, and Compliance, at multiple biotech companies.

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