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NCRAF's Spring Summit will have a return engagement by

Dr. Robert Califf

former FDA Commissioner


May 18, 2017

details to come.


RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

Click to see details


ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 




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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:


NCRAF March Presentation
Thursday, 16 March 2017

Demystifying US Biosimilars

The regulatory pathway for biosimilar approval introduced by the Biological Price Competition and Innovation Act of 2010 in the US is still fairly young. The first products approved under this pathway experienced some growing pains. This presentation provides an overview of the regulatory requirements for a biosimilar product approval, a case study of the first product approved, and the latest FDA guidance released on naming, interchangeability and the Totality-of-the-Evidence approach.


Speakers: Kirsten Messmer, Ph. D., RAC and

Charity M. Schuller, PharmD, RPh, MS, RAC 

Click here see full event details




In time for the 2017 RAC EU Exam

Video lectures are available for registrants to learn at your own pace
Course tuition is $50.00

Registration for this self-study is open from 7 February 2017 through 1 March 2018.


ECTD Group Meetings

The ECTD Group has moved to quarterly meetings using a discussion group format rather than lectures on a specific topic.
The meeting schedule is listed below.  The specific topics announced in an email sent out by the ECTD Group and will be posted prior to each meeting on the NCRAF website. The current meeting schedule is:

March 23 (Thursday): Opportunity to share take-aways from DIA RSIDM 2017 - Impact Pharma, 79 TW Alexander Drive, Building 4401, Suite 100, RTP, NC

June 27 (Tuesday): Review of new/updated eCTD guidance documents - location to be determined

September 19 (Tuesday): Program and location to be determined

December 5 (Tuesday): Program and location to be determined

Click here to see details