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.
NCRAF's Annual Spring Summit!
Thursday, May 1, 2014
Disrupting the Clinical Research Fabric in the US
A presentation by the nation's 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.
Date & Time:
Thursday, May 1, 2014
5:30 - 6:30 Networking and Hors d'oeuvre
6:30 - 8:30 Dinner and Presentation
DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park
4810 Page Creek Lane, Durham, North Carolina, 27703, USA
RAC(US) Seminar Series
Tuesdays starting June 3rd 2014 and continuing until at least September 30th, 2013, 6:00 - 8:00 pm
DCRI, The Lower Level Conference Room
2400 Pratt St.
Durham, NC 27705
There is a registration fee of $75 for the workshop. This fee provides for refreshments and instructional materials for the entire series. This fee does *not* include the recommended RAPS book "Fundamentals of Regulatory Affairs."
You MUST BE A CURRENT NCRAF MEMBER to register for the workshop. If you are not a current member please either renew your membership or become a new member (follow the links on the NCRAF home page). Once you are a member, ONLY THEN will you will be able to register for the workshop.
THE LINK LEADING TO THE REGISTRATION FORM WILL BE VISIBLE BELOW ONLY AFTER YOU LOG-IN TO THE WEBSITE.
OUTSIDE REGULATORY EVENTS of INTEREST
Regulatory Considerations for the Use and Development of In Vitro Diagnostics (IVDs)
Presenter: Robert J. Russell, President & CEO RJR Consulting, Inc. (Specializing in Life Science Technology Management/Global Regulatory Compliance/Global Business Develolpment
Thursday, April 24, 2014 on the UNC-CH Medical School Campus in Brinkhous-Bullitt Building, Room 219
Audience: Academic researchers, scientists, laboratory directors, and students engated in IVD research and/or development
This workshop will address these primary topics:
- How do regulators define "IVD"
- Types of IVDs
- Regulatory compliance considerations in the development of IVDs (U.S.)
- What investigators / clinical trial personnel need to know
- Clinical trial considerations in IVDs
- IVD registration with U.S. FDA
Register at: http://tracs.unc.edu/ivd-workshop
This Workshop is also offered as a webinar: https://unchealth.ncgovconnect.com/invitro/ Use the dial in number 1-988-685-5350; participant passcode 564470
This Workshop is presented by the North Carolina Translational Sciences Institute (NC TraCS) in collaboration with Research Triangle Institute (RTI)