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Skills and Exploration Workshop: Regulatory Affairs

Posted by on Tuesday, September 29, 2020 in Announcements, Upcoming BRET Office of Career Development Events .

The BRET Office of Career Development ASPIRE Program is excited to welcome regulatory expert Linda Bowen, RAC, FRAPS, to facilitate a small virtual regulatory-intensive workshop. All details below:

Transitioning to a Career in Regulatory Affairs and FDA Overview

Virtual Workshop
December 10, 11, 17, and 18
2-5 PM (central time)

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 invaluable talent for this career.

Applications are now open! Please complete the below link by Tuesday, December 1.

https://www.surveymonkey.com/r/VURegulatory2020 

Sponsored by the BRET Office of Career Development ASPIRE Program

Facilitator: Linda Bowen, RAC, FRAPS, Head of Global Regulatory Policy and Intelligence, Seagen, Inc. (formerly Seattle Genetics)

Guest speakers: To Be Announced

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.

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