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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

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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.

Upcoming NCRAF Events:

January 2018 Member's Meeting
(Happy New Year!)

Change Control Best Practices: Deciding when 510(k) is required for the device changes



Yuan Xu, President, Focus 42


Thursday, January 18, 2018 @ 6:30 p.m.


Note: The presentation will only available as  live webinar to registered participants due to snow conditions.







ECTD Group Meetings

The ECTD Group has moved to quarterly meetings using a discussion group format rather than lectures on a specific topic.
The meeting schedule is listed below.  The specific topics announced in an email sent out by the ECTD Group and will be posted prior to each meeting on the NCRAF website.

All meetings are scheduled for 12:00 - 1:30 pm.  Location is variable. Please check the schedule below for location updates.

The current meeting is:



Bring your questions and join in the fun! 
Topics that will be discussed include:
1.      Questions regarding electronic signatures of various types and how to handle them (or how the software handles them) in submissions
2.      Impact of installing Adobe upgrade on electronic signatures
3.      Update on the progress of the CMC Book of Knowledge

Cato Research is located at:

4364 S Alston Ave
Westpark Corporate Center
Durham, NC 27713


Click here to see details