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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 preparation courses

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.  

To that end, NCRAF annually sponsors 3 workshop series: one each in US, EU, and Canadian regulatory affairs.  The workshops are an excellent study aid for individuals preparing to take Regulatory Affairs Certification exams administered by the Regulatory Affairs Professionals Society.

 

NCRAF’s workshops also present a unique learning opportunity for any individual desiring an in-depth introduction to the full scope of regulatory affairs activities in the medical products industry, or wishing to broaden their current understanding of regulatory affairs.

Currently the RAC (US) seminar series is held annually from June-October, in preparation for the November RAC exams.  The RAC (EU) study group is timed for individuals taking the RAC exam in April, and the RAC (CAN) study group is held in late spring.  Follow the links below for more information, including current syllabi and registration information.

 

RAC (US)    RAC (CAN)     RAC (EU)

 

NCRAF has the support of very knowledgeable speakers who donate their time each year to share their experience and bring the regulations to life. NCRAF's training is designed to help NCRAF members prepare for the RAC exams through lectures on regulatory policies and procedures, and by encouraging interactions amongst the study group participants. Workshop participation is limited to current NCRAF members.