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Upcoming Events

 April 17th Program

Registration is open

Susan Watts
Title:  PREA Compliance and Pediatric Study Plans under FDASIA

 

 Spring Summit - May 1st

Robert M. Califf, MD

Title: Disrupting the Clinical Research Fabric in the US

Registration is open!

 

 

RAC US Seminar Series

Registration is now open

 

 

View recordings of past events:

Ken Edds Talk - What FDA Teaches It's Investigators

 

 

PDF Email

 

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.

Network with us now! NCRAF is on LinkedIn!

 

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),
and

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

Location:
DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park
4810 Page Creek Lane, Durham, North Carolina, 27703, USA

Register Now!



 

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.

Location & Time:

Quintiles Atrium
4820 Emperor Blvd.,
Durham, NC 27703
 
5:30 - 6:30 Networking
6:30 - 7:30 Presentation

Register Now! 


RAC(US) Seminar Series

 
Tuesdays starting June 3rd 2014 and continuing until at least September 30th, 2013, 6:00 - 8:00 pm 

Location
DCRI, The Lower Level Conference Room 
2400 Pratt St. 
Durham, NC 27705 

Registration Fee: 
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."

 Register Now!

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)