Seminar Series

Offered Spring 2014, Topics in Translational and Regulatory Science

Week 1 – Introduction / Story of the FDA – history, evolution – Dr. Robert Meyer
Week 2 –  Regulatory Science and the FDA – Dr. Robert Meyer
Week 3 – Clinical Development and the FDA – Dr. Robert Meyer
Week 4 – Primer in FDA law – Dr. Robert Meyer
Week 5 – What’s wrong with drug innovation? – Dr. Robert Meyer
Week 6 – Therapeutic Development/Regulation – Global Issues – Dr. Robert Meyer
Week 7 – Bench-to-Business: Translational Science in Academia – Dr. Greg Fralish
Week 8 – Generic and OTC  Drugs, their regulation and role in medicine – Dr. Robert Meyer
Week 10 – Perspectives on Translation from UVA Innovations – Michael Straightiff
Week 11 – Case Study on Regulatory Challenges   – Case of Chimerix/Compassionate use – Dr. Robert Meyer
Week 12 – Case Study on Translational/Regulatory Challenges – Direct-to-Consumer Genomics: 23andMe – Dr. Greg Fralish
Week 13 – Everything I Learned Wrestling with the FDA –     Pragmatic Lessons in FDA Interaction       Dr. John Herr
Week 14 – Wrap up