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Month: March 2020

Coronavirus: National Guidance

A national guidance has been published on the website van the FAMHP:
https://www.fagg.be/nl/news/coronavirus_belgische_richtsnoer_voor_het_beheer_van_klinische_proeven_tijdens_de

This national  guidance is to be read together with the latest version of the European guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic:
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf.

The document is the result of a collaboration between the FAMHP, the CT-College, BAREC and some clinical trial sites.

It is complementary to the European guidance and provides additional directions to clinical trial sponsors in the management of Belgian

(i) clinical trials for treatment or prevention of COVID-19, and
(ii) ongoing clinical trials.

This national guideline will be regularly adapted to the evolution of the pandemic.

European guidance on the management of clinical trials during the COVID-19 pandemic

A European guidance
(https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf) has been published, which will provide directions to sponsors and investigators on the subject of

  • clinical trials for treatment or prevention of COVID-19,
  • ongoing clinical trials in Belgium, and
  • the advice for new non-COVID-19-related clinical trials.

This guidance is supported by the FAMHP, BAREC and the CT-College.

Please note that on some subjects, a more detailed national guidance is being prepared on the conditions for direct distribution of the medicinal product to the patient.

This national guidance is expected to be published by the 25th of March 2020 and will be attuned to the European guidance.