Uitgelicht en gespot op internet (week 50, 2022)

Uitgelicht en gespot op internet (week 50, 2022)

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.

In deze laatste weken van het jaar wordt er nog aardig wat nieuws geproduceerd.

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Vincent Bontrop
www.bontrop.com

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Centrale Commissie Mensgebonden Onderzoek (CCMO)

Clinical trials, Decentralized Clinical Trials, Clinical research, Ethics, Inclusion, Informed consent

Clinical Trials Coordination and Advisory Group (CTAG)

The EMA informed that major blockers that are preventing the users to work smoothly on CTIS have been identified and that the service providers were committed to solve these blockers before 31 January 2023, date from which the use of CTIS will be compulsory. Member States expressed concerns about CTIS performance and some of the persisting blocking issues, calling for a fully operational system to be delivered on time. The Commission joined this call and encouraged good coordination at national level to ensure that the positions expressed at the EMA management board reflect the Member States needs expressed in this group. The Commission announced that the next steps would consist in identifying the persisting issues, prioritising them and allocating them to the different entities for possible resolution (EMA, Commission, Member States, CTAG, Commission Expert Group on Clinical Trials (CTEG), Clinical Trial Coordination Group (CTCG)). A sub-group of CTAG would be set up to prepare the work of an ad hoc CTAG plenary meeting in December 2022 dedicated to that follow-up.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pag. 2-3.

    • Union Controls

The Commission recalled the concerns expressed by Member States concerning the scope of the Union controls performed in the frame of the CTR. Notwithstanding that Union Controls is a critical method to verify whether Member States correctly supervise compliance with the CTR, the Commission has decided to pause the Union Controls until there is an internal review of the legal provisions. In relation to those Union Controls that had already started, the Commission has been liaising bi-laterally with the concerned Member State to seek agreement as to how to proceed.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pagina 3.

    • Proposals by ES and NL to facilitate clinical trial applications and CTR implementation

ES and NL presented a set of proposals to facilitate clinical trial applications and the CTR implementation. These proposals consisted in rationalising and optimising the work of the different groups involved in the implementation and enforcement of the CTR, updating and complementing guidance materials, developing a kit of first understanding of the CTR (a document summarising the new rules and pointing to the different guidance materials). The Commission welcomed these proposals and indicated that they will be considered, notably in the context of the survey follow-ups. Collaboration with the CTEG and other interested parties will be sought as appropriate.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pagina 3.

Clinical Trials Regulation (CTR)

‘Recommendation paper on decentralised elements in clinical trials’ gepubliceerd door EU Directoraat-generaal Gezondheid en Voedselveiligheid

Clinical Trials Transformation Initiative (CTTI)

College ter Beoordeling van Geneesmiddelen (CBG)

In de werkwijze van Synchron Research Services zijn tekortkomingen gezien bij bio-equivalentiestudies. Deze studies zijn nodig om de gelijkwaardigheid (bio-equivalentie) van een generiek medicijn met een al eerder goedgekeurd origineel medicijn aan te tonen. Door de tekortkomingen zijn er twijfels over de kwaliteit van de onderzoeken. Fabrikanten moeten nu met nieuwe bio-equivalentiestudies laten zien dat een generiek medicijn hetzelfde effect geeft als het originele medicijn.

bron: CBG nieuwsbericht d.d. 14-12-2022

Commissie Genetische Modificatie (COGEM)

Council for International Organizations of Medical Sciences
(CIOMS)

Dierexperimenteel onderzoek

Duchenne Muscular Dystrophy

Dutch Clinical Research Foundation (DCRF)

Dutch Oncology Research Platform (DORP)

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

The EMA will be closed for public holidays until 03/01/2023 included. All requests submitted to the EudraCT team after 21/12/2022 will be processed from 04/01/2023. This includes Service Now queries, emails to EudraCT_notification@ema.europa.eu and requests for assignments to trials for the purpose of posting results. We thank you for your understanding and we encourage you to refer to the Frequently Asked Questions in the meantime.

bron: EudraCT nieuwsbericht d.d. 15-12-2022.

EudraVigilance

European Clinical Research Infrastructure Network (ECRIN)

European Federation of Pharmaceutical Industries and Associations (EFPIA) 

European Health Data Space (EHDS)

European Medicines Agency (EMA)

The Agency informed the Board that the system delivers the functionality required for new clinical trial applications which will continue to be developed and enhanced. The Board noted the progress towards further stabilisation of the system in preparation of compulsory use. This stabilisation will improve user experience. The Agency informed the Board about its delivery plan to ensure no blocking technical issues in the core processes by the legal deadline and its commitment to this plan.

The Board welcomed the 2023 CTIS workplan which focusses on enhancing the user experience by implementing improvements in the most impactful functional areas of the system, future proofing and minimising risks to the technical core of CTIS. The Board also agreed to review the current rules on disclosure of certain clinical trial documents and a review of CTIS transparency measures for 2023. As the initiation of this workplan is subject to the stabilisation of the system, the Agency committed to update the Board on a weekly basis on the progress towards stabilisation and full functionality of the system. This update will start on Friday 16 December and stakeholders will be kept regularly informed.

The Agency informed the Board of the various potential risk scenarios and of the development of a business contingency plan.

bron: EMA Management Board: highlights of December 2022 meeting (16-12-2022).

FAIR (Findability, Accessibility, Interoperability & Reusability)

Good Clinical Practice (GCP)

Good Lay Summary Practice (GLSP)

Inspecties

Kunstmatige Intelligentie (KI)

Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)

Update on Medical Devices expert panels implementation: EMA presented the status development of the new scientific advice procedure for medical device manufacturers on clinical development strategy and clinical investigation and informed the audience of the launch of a pilot phase for Q1/2023. The pilot is aimed at gathering experience to shape the future scientific advice procedure after 2024. It was highlighted that as part of the pilot phase, the scientific advice will be free of charge. Additional information and guidance will be shared in advance of a dedicated webinar scheduled in January 2023. Medical device industry representatives welcomed the pilot phase.

bron: Meeting summary – Third Industry Standing Group (ISG) meeting (15-12-2022), pag. 3.

Medicines and Healthcare products Regulatory Agency (MHRA)

Methodology, Statistics

Proefschriften

Research Integrity

Suïcidepreventie

TransCelerate Biopharma Inc.

Universiteiten van Nederland, Biotech Booster

US Food and Drug Administration (FDA), Verenigde Staten

Wet zeggenschap lichaamsmateriaal (Wzl)

World Health Organization

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