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February 11 - February 13
DIA 2019 Regulatory Submissions, Information, and Document Management Forum
Kinetiq Executive Vice President James Riddle will be speaking at DIA’s Regulatory Submissions, Information, and Document Management Forum on February 13 at 8:45 am. James will be presenting on Part 11/Annex 11 Compliance at Research Sites.
Session 9: Track 3: Ensuring Part 11/Annex 11 Compliance at Research Sites
With the proliferation of electronic trial master files (eTMFs), electronic consent (eConsent) and other electronic regulatory document management systems in use at sites, sponsors and CROs are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 and Annex 11 regulations. In this session we will discuss various aspects and best practices for helping sites understand their commitments and document their compliance with the appropriate regulation.
Wednesday, February 13
8:30am – 9:45am
For more information on the conference, click here.