Professional development in regulatory affairs since 1992
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.
Speaker: Dr. David Shoemaker
"PDUFA V: Possibilities and Practical Expectations"
Campbell Univ. School of Pharmacy,
Morrisville, NC
Continues through March 20th
DCRI, North Pavillion
Rm 7015
Starts March 27th
DCRI, North Pavilion
Rm 7015
May 2012: NCRAF's Annual Luau Dinner
Speaker & Venue: TBD
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RAC preparation coursesNCRAF 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’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.
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. |