Interested in a Career in Regulatory Affairs?
Virtual Workshop
December 10, 11, 17, and 18
3-6 PM Eastern Time
(Completing this form does not obligate your attendance.)
Facilitator: Linda Bowen, RAC, FRAPS, Head of Global Regulatory Policy and Intelligence, Seagen, Inc.
Guest speakers: To Be Announced
Workshop Schedule
Day 1 (Thursday, December 10)
Transitioning to a career in Regulatory Affairs. Panel discussion on Regulatory Careers followed by Q&A. Careers to be discussed include regulatory strategist; CMC; labeling; Advertising and Promotion; Regulatory Policy and Intelligence
Day 2 (Friday, December 11)
- An Overview of the FDA including Food & Drug Law
- The Drug Review and Approval Process
- Expedited Pathways for Drugs and Biologics
Day 3 (Thursday, December 17)
- The OTC Regulatory Environment
- Generics
- Biosimilars
Day 4 (Friday, December 18)
- Regenerative Medicine
- Medical Devices
Items not covered during the session: cosmetics, combination products (for instance drug-device), dietary supplements, food, tobacco and veterinary (animal health) topics.
About The Facilitator
Linda Bowen has over 35 years experience in the Pharmaceutical Industry, the last 25 in regulatory affairs. She is an assistant professor at Temple University’s Regulatory Affairs Master’s Degree Program. Currently, she is Head of Global Regulatory Policy and Intelligence at Seagen, Inc. (formerly Seattle Genetics). Linda enjoys mentoring PhD scientists interested in regulatory affairs careers and feels strongly that PhDs are an invaluable talent for this career.
Sponsored by the BRET Office of Career Development ASPIRE Program at Vanderbilt School of Medicine