Publications

In September 2017, the EUCROF Pharmacovigilance (PV) Working Group published a paper titled: ”Pharmacovigilance in 2020: Boldly Shaping the Future An overview. Part 1: Where we are”.

This paper contained a series of “predictions” regarding the possible scenarios, involving the PV field in the 2020s.

Now, 5 years later and more than 2 years into the decade, the members of the PV working group thought it may be interesting to look back at those predictions and see where they were right and where they went wrong, taking into account the foreseeable and not foreseeable occurrences of the past few years.

Authors: Marco ANELLI, Xavier FOURNIE, Flemming Kjaer JORGENSEN, Zurab KOBERIDZE, Nicolas TSIAKKAS, Martijn VAN DE LEUR.

AI state-of-play around clinical research

15 Sep 23 vPR1 - Approved by eCF SC for Release

PV in the 2020s the Past and the Future

June 2023

The three white papers below were written by a joint task force from EUCROF and the eClinical Forum.

They provide details of the positions described in a position paper titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials” released on 26 February 2021 (below).

The Decommissioning of Computerised Systems Used in Clinical Trials

April 202

Nature of a Distributed Trial Master File TMF ‐ Practical Aspects

April 2023

Data Formats Used in Clinical Trials

April 2023

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