Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.
Event language: This event was held in Dutch.
On 16 May 2025, the GCP Committee organised an informative and interactive theme day centred on Revision 3 of ICH E6 GCP. As announced beforehand, this was not a GCP training day, but a day intended for exchanging views on the changes brought about by implementing ICH GCP R3.
The day was opened by DARQA chair Eveline Krijger. This was followed by a clear presentation on the history of R3 and the pillars on which the new version is built.
After this introduction by Henrieke de Bie on behalf of the GCP Committee, the programme continued until lunch with two presentations entitled “Implementing R3: Where to Begin?” Michael Smith explained the implementation plan from a sponsor’s perspective, while Edith Schafsfoort discussed what R3 means for the investigator. Both presentations clearly showed that each party faces its own challenges and that the transition from R2 to R3 involves a great deal of thought and additional documentation. R3 frequently uses the terms “fit for purpose” and “risk based”; the study team must therefore document its considerations and rationale throughout.
After lunch, QA’s perspective was addressed. Kees van der Ploeg explained how his organisation made choices concerning the implementation of risk-based QA.
The plenary session was led by Joke van Wageningen, and the day concluded with a Q&A session featuring two IGJ inspectors. This Q&A was again chaired by the DARQA chair. DARQA members had been able to submit questions well before the event, and during the session the inspectors explained the IGJ’s view. It is important to note that R3 applies not only to studies started on or after 23 July 2025. The IGJ also expects organisations to demonstrate implementation activities for studies already under way.
All in all, it was a dynamic and engaging day, which ended with enjoyable informal drinks.