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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To renew your membership, please perform the following steps - in order:
1. click on the Membership Renewal button (at the left side of the webpage).
2. login when asked using your info (If you don't have it or forgot it, contact Membership).
3. you will need a credit card (Visa, MC, AMEX).
4. Make sure to complete the entire process - you will be transferred to a confirmation page and will receive an email receipt at your listed email address.
5. Once logged in, the "Members Only" section will appear and you can navigate to the "Profile" page to change your password, etc.
NCRAF RAC EU 2014 WORKSHOP
Workshop begins Tuesday, January 7, 2014
NCRAF sponsors study group sessions for the Regulatory Affairs Certification (RAC) examinations for the US, Canadian, and European Union regulations, all of which are given annually by the Regulatory Affairs Professional Society (RAPS). Information on the RAPS certification exams can be found at the RAPS Web site.
NCRAF's training is designed to help NCRAF members prepare for the exams through lectures on regulatory policies and procedures, and by encouraging interactions amongst the study group participants. The EU RAC study group for winter/spring is scheduled to help participants prepare for the April RAC examinations.
NOTE: You MUST be an NCRAF Member to attend the study sessions. If you are not a member, please join by filling out the online Membership Application.
2014study group schedule
There will be 11 sessions and each session will meet on Tuesday from 6 p.m. to 7:30 p.m. in room 7015 of Duke's North Pavilion.
Weekly sessions begin Tuesday, 8 January 2014 and end 18 March 2014.
Any NCRAF Member may register (link to registration here) for the one or more of the European Union (EU) study sessions. Any single topic is an excellent continuing education opportunity for anyone interested in understanding some aspect of the EU regulations, and the ten week session is a valuable preparation course for those interested in sitting for the EU Regulatory Affairs Certification (RAC EU) examination.
To cover the cost of study materials:
- the cost of the 10-week series is $50, or
- you may pay $15 for any single session.
If you have questions, please email the RAC EU study coordinators or call (919) 668-8032.
The cost of the RAC exam (administered by RAPS) is not included in the study group fee. Please see the RAPS Web site for registration information, including exam costs and locations. If you are planning to take the RAC exam, purchase of the Fundamentals of EU Regulatory Affairs, 5th Edition published by RAPS, is highly recommended.
If you have no immediate plans to take the exam, the suggested readings and course materials will supply sufficient background.