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North Carolina Regulatory Affairs Forum

NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs activities as they apply to research, development, or manufacture of drugs, biologics, or medical devices.

Upcoming NCRAF Events:

US Legislation and the Resulting FDA Regulations/Guidances: The Odd Couple

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. 

2019 US RAC Course

REGISTER HERE for access to the recordings