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Upcoming Events

NCRAF Meeting: Presentation on Mobile Apps

Thursday, January 15, 2015

Quintiles Atrium

Register Today!


 NCRAF Meeting: Electronic Publishing for Paper People

 Thursday, February 19, 2015

 Quintiles Atrium

Register Today!


 NCRAF Meeting: Companion Diagnostics and FDA's Proposal for Regulation of LDTs

 Thursday, March 19, 2015

 Quintiles Atrium

Register Today!



View recordings and slide presentations of past events:

Kamali Chance - Development of Biosimilars in the U.S.-16 Oct 2014

Erin O- Reilly and Amanda Parrish - Discussions with CDRH about Pre-Market Device Issues and Clinical Research-18 Sep 2014

Susan Watts - PREA Compliance and Pediatric Study Plans under FDASIA-17 Apr 2014

Dr. Robert Califf - Disrupting Clinical Research-01 May 2014

Ken Edds Talk - What FDA Teaches Its Investigators-18 Apr 2013




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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.


To renew your membership, please perform the following steps - in order:

1. click on the Membership Renewal button (at left).
2. login when asked using your info (If you don't have it or forgot it, click on the “Forgot your username or password” link).
3. you will need a credit card (Visa, MC, AMEX).
4. Make sure to complete the entire process - you will receive an email receipt at your listed email address.
5. Once logged in, the "Members Only" section/tab will appear and you can navigate to the "Profile" page to change your password, etc.



February 2015 Monthly Meeting

Electronic Submissions for Paper People

Presented by BJ Witkin
Regulatory Publishing Manager, Impact Pharmaceutical Services

Thursday, February 19, 2015 (5:30 pm networking reception; 6:30 pm seminar)

Quintiles RTP Plaza Cafe (4820 Emperor Blvd., Durham NC 27703)

Register Today 




2015 EU RAC Workshop

Tuesdays, starting Jan. 6th continuing to March 10th, 2015
6:00 to 7:30 pm

Duke Clinical Research Institute
(NOT the building downtown)
Lower Level Lecture Hall

2400 Pratt St.
Durham, NC 27705

Registration is $50 for the full course or $15 per individual session

You must be an NCRAF member to register

Register Today