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 US WorkshopOne 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 & LocationSessions 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 & FeesAny 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.
Additional InformationThe 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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