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RAC EU Workshop begins Tuesday, January 5


Upcoming Events

"Orphan Devices" - Humanitarian Use Devices (HUDs)

speaker: Rebecca Carson Rogers (Schulman IRB)

Thursday, January 28, 2016

Quintiles Cafe' (Morrisville NC) or via webcast


 "Regulatory Intelligence"- Strategies for Drug Development

speakers: Charity Schuller and Kirsten Messmer (PPD)

 Thursday, February 18, 2016

 Quintiles Cafe' (Morrisville NC) or via webcast


 "Truth and Consequences - Pricing, Patient Access, and What's Next for BioPharm"

speaker: Jane Horvath (3D Communications)

Thursday, March 10, 2016

NC Biotechnology Center (RTP, NC) or via webcast



View recordings and slide presentations of past events:

Erin O'Reilly - Mobile Apps as Medical Devices - 15 January 2015

Kamali Chance - Development of Biosimilars in the U.S.-16 Oct 2014

Erin O- Reilly and Amanda Parrish - Discussions with CDRH about Pre-Market Device Issues and Clinical Research-18 Sep 2014

Susan Watts - PREA Compliance and Pediatric Study Plans under FDASIA-17 Apr 2014

Dr. Robert Califf - Disrupting Clinical Research-01 May 2014

Ken Edds Talk - What FDA Teaches Its Investigators-18 Apr 2013




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                                                      NCRAF is on LinkedIn!

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.

Upcoming  NCRAF Events:

NCRAF'S RAC EU Workshop - Begins January 5, 2016 through March 15, 2016
New Format!! Online and live lectures
Feb. 18: Regulatory Intelligence: Strategies for Drug Development
Speakers: Charity Schuller and Kirsten Messmer (PPD)


ECTD Group Monthly Meeting

Wednesday February 24 12 noon to 1:30 PM

Feedback from the annual DIA Conference
Impact Pharmaceutical Services

Click here to see full information

Non-NCRAF Regulatory-Related Event

BSI 2016 EU Medical Device Mini-Roadshow

Thursday, 17 March 2016

Sheraton Imperial Hotel
4700 Emperor Boulevard
Durham, NC 27703

Join  BSI experts at our half day Mini-Roadshow where you can learn about  some of the most significant evolving European Regulatory and  Compliance Expectations for CE Marking to help prepare for future  requirements

Click here to Register