This workshop is useful to grad students or postdocs interested in regulatory affairs and a variety of other careers. For instance, learning the clinical development process and regulatory milestones could be very useful to trainees interested in medical science liaison careers. Knowledge of how the regulatory filings affect patent and marketing exclusivity is helpful for trainees interested in consulting, patent law or technology transfer and commercialization.
Introduction to FDA & US Regulatory Affairs (Virtual)
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This workshop will help you gain a better understanding of regulatory affairs, including an overview of the FDA, the drug review and approval process, regulated devices and in vitro diagnostic products, and career paths in regulatory affairs.
Course Capacity: 30
Course Fee: $10
Dates & Times
Nov 9th, 11th, 16th, 18th, 5-7 PM.
Agenda
Day 1 (Tuesday November 9)
- An overview/history of the FDA
- Food & Drug Law
- The Drug Review and Approval Process
Day 2 (Thursday November 11)
- Expedited Pathways for Drugs & Biologics
- Generics
- Biosimilars
Day 3 (Tuesday November 16)
- The OTC Regulatory Environment
- Regenerative Medicine
- Medical Devices
Day 4 (Thursday November 18)
- Locating Regulatory Precedent
- Careers in Regulatory Affairs
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Instructor
Linda Bowen, MSc, RAC, FRAPS
Linda joined the BioPharma industry in 1983 and has spent the last 28 years in regulatory strategy, intelligence and policy roles. She is Head of Regulatory Policy and Intelligence at Seagen (formerly Seattle Genetics) and Assistant Professor in the Temple University RAQA graduate program. She attained Regulatory Affairs Certification for the US, Canada and Europe and was inducted into the 2011 Class of RAPS Fellows. Linda was honored with the RAPS 2020 Founder’s Award and the DIA 2012 and 2019 Excellence in Volunteer Leadership Awards. She chairs the DIA Regulatory Affairs Community and is founder of the DIA Regulatory Intelligence Working Group. She is most proud of her role as an educator and mentor to those entering the RA profession.
The mini-course has helped to better prepare me for a transition to a career in life sciences consulting by giving me a better understanding of the regulatory space and teaching me how to uncover information I may need from the vast array of government databases available.