North Carolina Regulatory Affairs Forum
NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. 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.
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To renew your membership, please perform the following steps - in order:
1. click on the Membership Renewal button (at the left side of the webpage).
2. login when asked using your info (If you don't have it or forgot it, contact Membership).
3. you will need a credit card (Visa, MC, AMEX).
4. Make sure to complete the entire process - you will be transferred to a confirmation page and will receive an email receipt at your listed email address.
5. Once logged in, the "Members Only" section will appear and you can navigate to the "Profile" page to change your password, etc.
Save the Date for the Spring Summit!
Thursday, May 1, 2014
A presentation by the nations premier clinical trials change agent
Robert M. Califf, M.D.,
Vice Chancellor of Clinical and Translational Research,
Director of the Duke Translational Medicine Institute (DTMI),
Professor of medicine in the Division of Cardiology
at the Duke University Medical Center.
DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park
4810 Page Creek Lane, Durham, North Carolina, 27703, USA
Mark you calendars. Registration will open soon.
NCRAF MARCH MEETING - Thursday, March 20, 2014
Preparing for an IND begins with end in mind. What is the proposed indication, patient population, dosing frequency, route of administration and duration? Taking into consideration the final marketed product, one can work back through a general investigational plan to develop initial clinical plans, preclinical studies to support the proposed clinical plans and manufacturing. This talk will discuss the important elements to consider for clinical, preclinical and manufacturing in preparing for an IND, considerations for a pre-IND meeting and some practical insight into potential hurdles, how to address/avoid them, IND content, and FDA communications.
David Houck, Ph.D. is the President of Pharmakey, LLC and is a chemist and drug developer with over 25 years of experience in the pharmaceutical and biotechnology industries. His technical expertise is formulation development, manufacture, and release testing of their therapeutic candidates for preclinical and clinical studies. Dr. Houck has pharmaceutical and biotechnology experience at Merck, Sterling Winthrop, OSI Pharmaceuticals, and Scynexis, and has authored/co-authored over 25 articles, and holds ten patents.
Dana Minnick, Ph.D. has over 15 years experience in the pharmaceutical industry supporting programs throughout the drug development lifecycle. She is a board certified toxicologist with particular expertise in nonclinical safety assessment and regulatory affairs. Dana is currently a drug development regulatory project manager in the Global Health Technologies group. She has held previous scientific and regulatory roles in a large pharmaceutical company, a small biotech, a CRO and a consulting firm.
Anita Woodring, MS, RAC, is a regulatory project leader at RTI International. She has 20 years’ experience in regulatory and clinical in all phases of clinical research. Anita has contributed to the filing of numerous INDs and managed Phase 1 through Phase 3 clinical research trials. In addition, Anita has contributed to Type A, B and C meetings with FDA, NDAs and advisory committee teams and has worked in multiple therapeutic areas.
NCRAF APRIL MEETING - Thursday, April 17, 2014
PREA Compliance and Pediatric Study Plans under FDASIA - Susan Watts
Beginning January 2013 under FDASIA, companies are required to submit a Pediatric Study Plan (PSP) for new products in development 60 calendar days after an end-of-Phase 2 meeting or such other time as agreed with FDA. FDA has a 270-day review clock for PSP agreement and confirmation. A PSP template, draft guidance, and review SOP have been issued by FDA. The speaker will discuss the new pediatric requirements and provide preliminary insights into PSPs under CDER and CBER
Susan Watts is Director, Global Regulatory Affairs at GlaxoSmithKline. She has been working in regulatory affairs for 23 years, primarily with drugs and biopharmaceuticals for anti-viral, immunoinflammatory, and metabolic diseases.
MARCH eCTD Group Meeting
Wednesday, March 12, 2014, 12 noon to 1:30 at
Impact Pharmaceutical Services
79 TW Alexander Drive
Building 4401, Suite 100,
Kathy Elks will present the results of the ECTD Professional Survey that was conducted in the Fall of 2013
Mr. Don Alexander from Carlyle and Conlan, an Executive and Professional Search Company, will give a presentation on the Trends and Employment Dynamics in the Industry
NCRAF RAC EU 2014 WORKSHOP
Workshop begins Tuesday, January 7, 2014
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.
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.
2014 study group schedule
There will be 11 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, 8 January 2014 and end 18 March 2014.
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 RAC EU study coordinators or call (919) 668-8032.
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.