Uitgelicht en gespot op internet (week 11, 2023)

Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

Met vriendelijke groet,

Vincent Bontrop

U kunt met mij linken via LinkedIn.

Centrale Commissie Dierproeven (CCD), Dierexperimenteel onderzoek

Centrale Commissie Mensgebonden Onderzoek (CCMO)

Clinical Trials Coordination Group (CTCG)

This Question and Answers document on CCT and CTIS  will give an answer on the most important factors to be considered.

bron: CTCG ‘Key documents list’

European Medicines Agency (EMA)

Since 31 January 2023, the use of the Clinical Trials Information System (CTIS) is mandatory for initial clinical trial applications and serves as the single-entry point for submission by sponsors and for regulatory assessment in the EU/EEA. In the first meeting after this milestone, the Board received an update on recent operational experience with CTIS and on the latest improvements implemented in the system. Over 320 clinical trials authorised under the Clinical Trials Regulation are available in CTIS. EMA reported on the next steps, including upcoming system releases planned for the first quarter of 2023. Enhancements are planned throughout 2023 aimed at further improving the CTIS user experience. The Board was updated on the communication campaign supporting implementation of the Clinical Trials Regulation and welcomed EMA’s ongoing efforts to support sponsor and Member State CTIS users via trainings, information events and the publication of related materials.

bron: EMA Management Board: highlights of March 2023 meeting d.d. 17-03-2023

Clinical Trial Regulation (CTR), Clinical Trials Information System (CTIS)

  • "The number of CTAs uploaded by the Member States in EudraCT as individual clinical trial protocol, per month during the selected period7. Overall 2,231 CTAs have been uploaded in EudraCT". Source: Key performance indicators (KPIs) to monitor the European clinical trials environment, page 4.

European CRO Federation (EUCROF)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Federatie Medisch Specialisten (FMS)


Genetic studies, Diversity

International Council for Harmonisation (ICH)

Integraal Kankercentrum Nederland (IKNL)

International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

Kunstmatige Intelligentie (KI)

Nationaal Comité advies dierproevenbeleid (NCad)

Nieuwsbrief voor Goede Onderzoekspraktijken

Minister van Volksgezondheid, Welzijn en Sport


US Food and Drug Administration’s (FDA)


Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties

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