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The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites). For draft documents, comments are submitted to regulatory authorities. Final documents are mapped to the "eCF Requirements" which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 unique statements. This is updated annually and released to eCF members. Previous year's "eCF Reqs" are released to the public.The eCF Requirements can be used to determine if systems that handle data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features. Each eCF member company may have one representative on the REG team.
eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data
Log in to your eCF website account to see more:
RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities?
The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.
eCF Public Webinar March: Turning the ATRA Position Paper into Practice
This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"
The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am DST / 1:00 pm UTC. Sign up here
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3