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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.

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Upcoming NCRAF Events:

IND Submissions - Lessons Learned 

Speaker:  Will Lee

VP Regulatory Affairs, Cato Research

Thursday, February 13th 

 5:30-6:30 Networking Reception

6:30 - 7:30 Presentation 

This event will be in-person (RTP location TBD)

It will also be available by Webex 
Webex information will be mailed to registrants at a later date

NCRAF is fortunate to have long-time members who are willing to share the benefit of their experience with others.  For our February talk, Will Lee has generously volunteered to talk about some of the more notable lessons learned from filing INDs during his 20+ years in the field.

Will Lee is Vice President, Regulatory Affairs at Cato Research, a CRO based in Durham.  He has more than 20 years’ experience in regulatory affairs dealing with small-molecule drugs, devices, and biologics.  His focus is on biologics, mainly cell therapy and gene therapy. Before joining Cato Research, he was Principal Scientist at Viagene/Chiron, a gene therapy start-up based in San Diego.  He holds a Ph.D. in Genetics from Cornell University.


2019 US RAC Course

REGISTER HERE for access to the recordings