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Life Science & Healthcare FDA Regulatory Advisor AMA

4/15
5:00 pm — 6:00 pm
Wednesday, April 15, 2020
Virtual Event via Zoom

Update on COVID-19: The Harvard Innovation Labs has always been a hub for inventive thinking. All our programming and events will continue virtually. We will email Zoom information after you register.

Overview: All founders and innovators in the healthcare & life sciences space will be able to ask questions to a former FDA & USP regulatory lead scientist and policy advisor in an AMA style format.

Speaker: Dr. Mamta Gautam-Basak

Speaker Bio: Dr. Mamta Gautam-Basak, former FDA regulatory scientist and policy advisor, will be joining us on Thursday, April 16th at 5pm for a Ask-Me-Anything Session with Founders. Mamta will be answering questions on FDA regulatory pathways, regulatory strategy, and policy, as well as best practices for life science founders communicating with regulatory bodies.

Dr. Mamta Gautam-Basak currently serves as a senior technical advisor for US Pharmacopeia’s Promoting the Quality of Medicines (PQM+) program, a USAID-funded initiative that helps low- and middle-income countries ensure the quality of and increase the supply of priority medicines. Prior to USP, Mamta spent 24 years with the Food and Drug Administration (FDA) working in various roles primarily within the Center for Drug Evaluation and Research (CDER). She was consistently recognized for her ability to bring technical insight to regulatory, policy, quality, and compliance challenges for global pharmaceutical manufacturers. She has seen what happens when companies miss critical requirements and details, and is excited to support Harvard entrepreneurs navigate navigate regulatory hurdles to bring therapeutics to market in a cost-effective manner.

Mamta received her Ph.D. in analytical chemistry from the Indian Institute of Technology-Delhi and her M.Sc. and B.Sc. in chemistry from University of Delhi. She currently serves as an executive in residence at Columbia University and a mentor with the SkyDeck accelerator at UC Berkeley. She also serves as a regulatory advisor for therapeutic startups and is available to assist Harvard Innovation Lab teams through office hours (please reach out directly to set up an appointment).

Life Science & Healthcare FDA Regulatory Advisor AMA
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