North Carolina Regulatory Affairs Forum
Professional development in regulatory affairs since 1992
UPCOMING EVENTS
Register HERE
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ECTD Group Meetings
These meetings have resumed as quarterly get togethers for 2018
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Follow @ncraf 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:GDPR: What We (Think) We Know So Far
Speaker: Denise Sturdy, JD, RAC Senior Regulatory Affairs Consultant, Duke Clinical Research Institute
Thursday, December 13, 2018 @ 6:00 p.m.
This seminar will be a WebEx Only event
Even after several years of development and a two year post enactment roll-in period, most US companies were caught unawares when the the European General Data Protection Regulation (GDPR) went into effect this May. In the absence of official Guidance, companies have been feeling their way along, with reactions ranging from panicked attempts to address all possibilities to reckless disregard of GDPR's implications on their business. This discussion will focus on the aspects of the GDPR that most affect clinical research and share what has been learned through dealings with European sponsors, and conversations with other affected US companies, outside law firms and offthe record thoughts from regulators on both sides of the Atlantic.
Denise Sturdy is Senior Regulatory Affairs Consultant at the Duke Clinical Research Institute. A licensed attorney, RAC certified in both the US and EU regulations, Denise has been working with national organizations on facilitating the practical application of GDPR to the conduct of multi-national human subject research by US research organizations.
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ECTD Group MeetingsThe ECTD Group has moved to quarterly meetings using a discussion group format rather than lectures on a specific topic. All meetings are scheduled for 12:00 - 1:30 pm. Location is variable. Please check the schedule for location updates.
Cato Research is located at: 4364 S Alston Ave
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