North Carolina Regulatory Affairs Forum

NCRAF Events in April and May - Registration Now Open!

April 24 -  Special Presentation! - Lessons Learned: Effective Inspection Readiness Program
SPEAKER: Carmen Amador, Chief Quality Officer, the LaSalle Group
This event will be held at the NC Biotech Center (also available hybrid via Zoom) - Please note start times: networking reception 6-7 pm; hybrid seminar presentation 7-8:30 pm.

May 20 - Spring Symposium - Regulatory Strategy for Drug-Led Combination Products
SPEAKER: Susan Neadle, MS, BS, FRAPS, FAAO, Principal Consultant at Combination Products Consulting Services LLC.  
This year's Spring Symposium will (once again) be held at the Doubletree RDU at RTP - Register by May 10 for best pricing!
See "Upcoming Events" for NCRAF event details and registration for both events.  Become an NCRAF member to enjoy significant discounts for registration at every NCRAF event!  Most NCRAF events are free for our members.
 

 Other Local events of interest:

 The 2024 Biomanufacturing and Process Development (BPD) Cell and Gene Therapy Symposium & Vendor Show will be held April 25 in Chapel Hill, NC.  This full-day event features talks on technical advances and challenges in this field from 8 speakers, plus suppliers and service providers supporting CGT process and product development activities.  https://www.ncbiotech.org/events/bpd-cell-and-gene-therapy-symposium-vendor-show-1

  The 2024 AMWA Carolinas Chapter Conference is coming up on May 3. This year’s full-day, in-person conference in Chapel Hill will feature 2 educational tracks about leadership, regulatory writing, plain language, lean writing, and more!

 Check out the brochure and register on the conference webpage: https://www.amwacarolinas.org/wp/2024-spring-conference/

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Registration for the 2023 RAC Workshops are still open!!

You must be a member to register (standard membership is currently $50).
Workshop registration is $75

The Live sessions of the Pharm/Bio Workshop for 2023 are complete. Recordings are available for viewing in the NCRAF LMS (https://ncraf.mclms.net/en/). 

This workshop series is a comprehensive overview of regulatory requirements for development, manufacture, marketing and compliance for drug and biological human medicines in the US, EU, and other countries. It is especially useful for those studying for the RAC (Drugs) certification exam, but also is valuable for anyone interested in learning more about WHY the industry operates as it does. Each session in the series features a lecturer with relevant industry or other "field" experience to illustrate the concepts discussed.

Pharm_Bio Workshop Registration

  

NCRAF did NOT host a live version of the 2023 RAC Device Workshop.

With registration, you will gain access to the recordings of the 2022 Device Workshop.
The link to view the recordings and slides will be found in your confirmation email.

Device Workshop Registration

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