FDA Regulations: Considerations for your new technology
Join us and our regulatory expert Anne Marie Finley for an online lunch and learn on FDA’s regulatory review and research activities as well as its product quality and safety responsibilities. Learn the basics of FDA authority and regulation for drugs and devices, regulatory strategy considerations for start up companies and then join us in a Q&A to ask the expert!
Note: Zoom link will be sent out after registration
Speaker(s): About the Presenter: Anne Marie Finley Anne Marie Finley is the President of Biotech Policy Group LLC, an FDA regulatory strategy and health policy consulting firm she founded. Biotech Policy Group specializes in regulatory planning and solutions for pharmaceutical, device, diagnostic and food clients. Her previous corporate positions include serving as Vice President of Regulatory Policy, Government Relations and Health Policy at three global pharmaceutical companies (Celgene, GE Healthcare and Amersham Health) and also at Hershey Foods, a Fortune 500 company. Anne Marie also has extensive senior level government experience. She was Chief Investigator for HHS and FDA programs at the US House of Representatives’ Committee on Government Reform. She was an FDA regulatory consultant to the US Department of Health and Human Services (HHS) Biomedical Research and Development Authority (BARDA) and was also a member of the HHS Advisory Committee on Blood Safety and Availability, which reviewed safety and availab
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Fee: No Cost