NCRAF - US Legislation and the Resulting FDA Regulations/Guidances: The Odd Couple
Date and Time
Thursday Oct 24, 2019
5:30 PM - 7:30 PM EDT
5:30 - 6:30 Networking
6:30 - 7:30 Presentation
Location
Rho, Inc.
2635 East, NC-54
Durham, NC 27713
Fees/Admission
Contact Information
Andrea Mospan
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Description
David Shoemaker, Senior Vice President, Research and Development, Rho, Inc.
This talk will be a presentation of the speaker's perspective of the evolution of the U.S. regulatory environment over his 25+ year career in pharmaceutical product development. The impact of US legislation from the pre-PDUFA era to the current day on the development of regulations and guidances for drugs and biologics will be examined emphasizing the original intent of congress versus the ultimate result. Specific examples from the speaker's experience will be highlighted to demonstrate the development of his personal perspective of the changing U.S. regulatory environment including his current biases, suggested best practices, and anticipated trends for the future.
