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Membership Renewal

Upcoming Events

Feb 16, 2012 Program

Speaker: Amy Kniefel,
Director, Regulatory Affairs, Aptiv Solutions

Title: eSub-friendly Module 3: Considerations on How to Write an NDA Chemistry Section in an eCTD World

Location: Campbell University RTP Campus, Rm 107.

Mar 14, 2012 Program

Speaker: Dr. David Shoemaker

"PDUFA V:  Possibilities and Practical Expectations"

Campbell Univ. School of Pharmacy,
Morrisville, NC


RAC EU Workshop

Continues through March 20th

DCRI, North Pavillion
Rm 7015

RAC Canada Workshop

Starts March 27th

DCRI, North Pavilion
Rm 7015

May 2012: NCRAF's Annual Luau Dinner
Speaker & Venue: TBD


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RAC EU Workshop

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.

Register Now!

 


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.

 

2012 study group schedule

There will be 10 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, 10 January 2012 and end 13 March 2012.  


Here is the 2012 EU RAC syllabus.  

Registration

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 This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (919) 668-8032.

 

Additional Details

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.