Welcome

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.

NCRAF on LinkedIN !  

 

Upcoming EVENTS - Mark your calendars!

 

NCRAF March Program. March 25, 2010

CMC Strategies for Initial IND and Phase 1 Clinical Trials, and Recent Regulatory Experiences

also known as

Same Strategy, Same Agency, Different Outcomes

 

Speaker:  David Houck, PhD,

President; Chief Regulatory and CMC Consultant
at Pharmakey LLC.

Register using the link in Attend Events box at left.

 

NEW!!  Basics of European Regulatory Affairs

A Course Presented by TOPRA.  (Ref: BASNA2/10).

April 21, 2010; 10am to 4pm; Information Brochure Here (3Mb pdf).

This is a new course, where you will have the opportunity to learn about European Regulatory Affairs direct from the source. These courses are limited to 30 attendees to ensure a relaxed informal environment with plenty of opportunity for interaction with the speakers.

To be held at Stiefel Laboratories.   

 

 

Canadian (RAC) Study Group. 

Starting March 23, 2010

This weekly study group is a comprehensive introduction to Canadian Regulatory Affairs. It will be especially useful for anyone planning to sit for the RAC(Can) exam, but is open to any interested individuals who are current NCRAF members.


The series will run on Tuesday evenings from 6-7:30 pm, starting 23 March 2010 and ending 25 May 2010.  Location: Duke's North Pavilion (DCRI), room 7015.

Register using the link in Attend Events box at left.


 

EU (RAC) Study Group.  Final Meeting is Tuesday, March 9.

This weekly study group is a comprehensive introduction to European Regulatory Affairs. It will be especially useful for anyone planning to sit for the RAC(EU) exam, but is open to any interested individuals who are current NCRAF members.

The series will run on Tuesday evenings from 6-7:30 pm, starting 05-January-2010 and ending 09-March-2010. Location: Duke's North Pavilion (DCRI), room 7015.

To register, see the link in the "Attend Events" box to the left.

 

 

Events


Click here to view and register for upcoming events.

Education


Click here for information on NCRAF  educational courses including the RAC preparation courses.

Membership


Read the benefits of joining NCRAF here including free admission to local educational seminars and discounted admission to special events.