NEWS

European Guidance: UPDATE

Today an updated version of the European guidance was published on EudraLex10: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf The related press release announcing the publication can be found here:...

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2nd version European Guidance

Please find an updated version of the European guidance was published on EudraLex-10. Go to document The aim is to provide sponsors and investigators with guidance on how to mitigate the effects of the pandemic in order to protect the safety, well-being and integrity...

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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_deThis national  guidance is to be read together with the latest version of the European...

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Law on Clinical Trial on Medicinal products

Moniteur Belge - Belgisch Staatsblad N.39 22 May 2017- Wetsontwerp/Projet de Loi  Wet betreffende klinische proeven met geneesmiddelen voor menselijk gebruik. Loi relative aux essais cliniques de médicaments à usage humain.     If you would like to read more...

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Medical Device Directive & Clinical Investigation

"Impact of the new regulation on clinical investigation in Belgium." A presentation by Steve Eglem, FAMHP.Available on demand: info@barec.be If you would like to read more about this, please consider becoming a Barec-member and acquire access to our member area....

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