Note: This event will be held in English! For an announcement in English, see below.

Naar aanleiding van de revisie van ICH E6 Good Clinical Practice, organiseert de GCP-commissie op vrijdag 16 mei 2025 een 1-daags event. Doel van het event is om gedachten uit te wisselen over de veranderingen binnen GCP aan de hand van presentaties, discussies en twee Q&A sessies, waarvan de laatste met de twee inspecteurs van de Inspectie Gezondheidszorg en Jeugd (IGJ).

Deze dag zal geen daadwerkelijke training vormen op de revisie van GCP, maar dient als mogelijkheid tot verdere verdieping in de materie en om praktische handvaten te delen hoe als GCP quality professional om te gaan met de veranderingen. Mocht je dat dus nog niet vaak genoeg gedaan hebben: Zorg dat je ICH E6 R3 nog eens goed doorleest voor het event!

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Following the revision of ICH E6 Good Clinical Practice, the GCP committee is organising a one-day event on Friday 16 May 2025. Purpose of the event is to exchange thoughts about the changes in GCP, based on presentations, discussions and two Q&A sessions, one of which will be with two inspectors from the Dutch Inspectorate IGJ.

This day will not serve as a training on the GCP revision, but will be an opportunity to take a deeper dive into ICH E6 R3 and for exchanging practical tips how to deal with the revision as a GCP quality professional. Make sure you review ICH E6 R3 once again prior to the event!

AGENDA:

Aanmelden voor deelname kan nog tot 14 mei via de DARQA website! 

European Commission evaluation of EU Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice (GLP).

The European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) has launched an evaluation study of the EU Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice (GLP). 

The study is conducted by Technopolis Group and Milieu. The aim of the study is to provide data, analysis and evidence for the Commission to evaluate the extent to which the Directives are fit for purpose and have delivered, at minimum cost, the desired changes to European businesses and citizens.  As part of this study, the contractor is consulting with targeted stakeholder groups and public authorities to collect relevant data and views.

DARQA members have the opportunity to get involved. See details below, provided by the Technopolis Group:

“Technopolis Group, in collaboration with Milieu, are conducting the ongoing evaluation study of EU Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice (GLP), commissioned by the European Commission (DG GROW F.2). As part of the study’s interim phase, we are collecting evidence on the costs and benefits and a targeted stakeholder consultation (survey).  For the targeted stakeholder consultation we would be appreciative if you could provide feedback, you can find it here, and in URL form here: https://eu.mar.medallia.com/?e=440204&d=e&h=A833B3E4108CB8E&l=en.

For the CBA we are collecting evidence on the costs and benefits associated with the implementation of these Directives, specifically from the perspective of industry. If you would like to take part in the CBA, your insights would be appreciated in assessing the efficiency of the Directives and providing the European Commission with monetary feedback. You can contact us at: glp_evaluation@technopolis-group.com, if you would like to take part or for any other such information on the study.”