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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 US Workshop

One of the more valuable of our NCRAF membership benefits is the annual US RAC workshop, held every summer through fall in preparation for the November RAC exams. NCRAF has the support of very knowledgeable speakers who donate their time each year to share their experience and bring the regulations to life. This workshop is ideal for those who would like to broaden their understanding of FDA regulations, earn CEU's for the RAC certification currently held, or prepare for taking the RAC.

US RAC Workshop Dates & Location

Sessions will be held Tuesday evenings, 6-8 pm at DCRI (Duke Clinical Research Institute, Lower Level conference room) beginning about the first Tuesday in June and continuing through the end of September. See each years' specific workshop announcement or NCRAF's event calendar.

Registration & Fees

Any NCRAF Member may register for the workshop, but space is limited, so register early to ensure you have a space. There is a workshop fee of $75 to cover the cost of food and lecture materials.

Members: if you are a current NCRAF member, please log in with your username and password, then select the "RAC (US)" item in the left frame of the website.  If you do not yet have a username and password for your NCRAF membership, then please click here to register.


Non-Members: if you are NOT currently a NCRAF member, then you must first join NCRAF by clicking here - Membership Application - so that you are properly listed in our membership database. THEN, register for the course through the Events calendar of the website. 

Additional Information

The cost of the RAC exam (~$500; administered by RAPS) is not included in the study group fee. Please see the RAPS Web site (www.raps.org) for registration information, including exam costs and locations.

If you are planning to take the RAC exam, purchase of the current edition of Fundamentals of US Regulatory Affairs (published by RAPS) is highly recommended. A group order for the book will be placed through the workshop, which will offer a significant discount to workshop participants. Please email the coordinators at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it   and indicate that you wish to join in the group purchase.

If you have no immediate plans to take the exam, the suggested readings and course materials will supply sufficient background for the group discussions.

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