Uitgelicht en gespot op internet (week 50, 2020)

Uitgelicht en gespot op internet (week 50, 2020)

Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:

Associatie van Contract Research Organisaties in Nederland (ACRON)

Brexit

From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:

  1. Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
  2. Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
  3. Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.

Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application … . The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.

…..

In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:

  • Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
  • Update section D.9.2.4.4 specifying “Northern Ireland” in the country field

When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.

-Bron: EudraCT Public website d.d. 7 december 2020

Biobanken

BBMRI.nl

COVID-19

Data sharing

Decentralized Trials & Research Alliance (DTRA) 

European Data Protection Supervisor (EDPS)

European Medicines Agency (EMA), Clinical Trials Information System (CTIS), ECTR

Health-RI

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Ministerie van Volksgezondheid, Welzijn en Sport (VWS)

Patient Focus Development

Persoonsgegevens

ZonMw

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