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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.


Call for Volunteers!

NCRAF needs your support! 

We are looking for volunteers for the Executive Committee (EC) in the following positions:
  • President-elect (3-year term) - Serves as President-elect (shadowing the President) in 2023, President in 2024, and past-president (advisory role) in 2025. The President is responsible for hosting EC meetings, supporting the EC where needed, and general oversight of NCRAF.
  • VP Programs (1-year term) - Plans NCRAF's monthly seminars and programs, including recruitment of speakers and selecting venues and catering. Term will end December 2023.
  • VP Communications (2-year term) - Responsible for sending out NCRAF newsletters. Term will end December 2024.
  • Treasurer (1-year term) - Keeps track of NCRAF's financial standing, generates monthly reports, handles reimbursements, etc. Term will end December 2023.
  • Secretary (2-year term) - Generates meeting minutes for all EC meetings. Term will end December 2024.
  • Education Chair (1-year term) - Plans NCRAF's annual summer Drugs and Biologics Workshop and Devices Workshop, including recruitment of speakers. Term will end December 2023.

For more information and to notify NCRAF you'd like to run for a position, please contact [email protected] by 30 November 2022



The Roundtable Dinner is Back!

Wednesday Nov. 16 at the Friday Conference Center, Chapel Hill

Registration is Open!
As in years past, our Roundtable Dinner will feature a networking reception with complimentary wine and hors d'oeuvre, followed by buffet dinner with seating at multiple tables, each with a different speaker and discussion topic. Each table will be a unique opportunity to learn about a topic of your choosing with a local expert in the topic, in a small-group setting (6-10 persons/table). 
Registration is $25 for current NCRAF members, $45 for non-members,
Discount rate available for NCRAF members who are students/post-docs/unemployed job-seekers.5:30 to 6:30 pm Networking6:30 to 8:00 pm  Dinner and Discussion
Table # Speaker & bio Topic & Description

Clare Matti, Associate Director, Regulatory Affairs, The FlexPro Group

EU Clinical Trial Regulation

A profound change was finally realized in January 2022 when the European Union’s Clinical Trial Regulation (CTR) entered into application with the “go live” of the Clinical Trials Information System (CTIS). (more...)

2  ---



Cynthia Nolte, RAC, Director Regulatory Affairs
, Strategic Regulatory Service, ICON, plc.

MDR/IVDR Technical Documentation Audits – War Stories from the Audit Trenches




Charles Jagun, Regulatory Senior Manager, Merz Aesthetics

Regulatory Intelligence – Medical Devices

 As product designs, development, and manufacturing change get more innovative, regulatory authorities have also become proactive and alert to guarantee medical device safety and effectiveness. (more...)




6 ---  <<cancelled>>
Drusilla Scott, PhD, RAC, VP Regulatory Affairs,

Sobi, Inc.

Manna from Heaven - It's PDUFA VII !

On September 30, 2022, Congress enacted legislation to reauthorize the FDA user fee program for prescription drugs and biologics (PDUFA), as well as the programs for medical devices, generic drugs and biosimilars. These reauthorizations were included in the Continuing Resolution that funded the federal government until December 16, 2022. (more...)



8  ---






Kirsten Messmer, PhD, RAC, Senior Research Analyst, Agency IQ

Advanced Therapies – Lessons learned from regulatory challenges

 Advanced therapies are one of the fastest growth sectors in the biopharmaceutical industry. Several factors contribute or pose unique challenges for the development of these highly innovative products including: (more...)





Demetrius Carter, MBA, PMP, RAC-US, CLSSGB
SVP Services Operations & Regulatory Services; Certara Synchrogenix

Making the Switch: Transitioning your career into Regulatory Writing







Marissa Berry, Senior Manager of Regulatory Strategy, Hyloris Pharmaceuticals

Scott Kelly, President, Scott Kelly Consulting, Inc.

The Logistics of Starting Your Own LLC/Consulting Company

 In this discussion, we will talk about the steps necessary for starting an LLC in North Carolina, the potential benefits of filing your LLC as an S corporation, and some of the pros and cons (more...)


Devin Rosenthal, VP NovaQuest Capital Management

Regulatory Affairs Influence in Investment Decision-making

Some may think of regulatory affairs as just a box-checking requirement or a paperwork-heavy burden, but did you know that it’s also foundational for the multimillion-dollar financings that fuel biopharma companies? (more...)


Kevin B Johnson, Chief Regulatory Officer, Ring Therapeutics

Storytelling, Hypnosis, and Vulcan Mind Melds:  The Art and Science of Persuasion in Regulatory Interactions




Registration for the 2022 RAC Workshops is still OPEN!!

You must be a member to register. Workshop registration is $75

Live sessions were held from June-September and are now complete.

Recordings of all sessions are still available.  

REGISTER for Device Workshop
REGISTER for Pharm-Bio Workshop



Membership dues for 2022 will continue to be $20 for the year.

When your membership renewal comes up during the 2022 calendar year, you will receive, via email,
an invoice for $20.
Please pay via the invoice (there's a link in the email),
the old "log in to the website and renew" is no longer available.