https://www.ema.europa.eu/en/documents/other/electronic-submission-investigational-medicinal-product-imp-data-extended-eudravigilance-medicinal_.pdf

https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended_en.pdf

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-october-2021

https://www.ema.europa.eu/en/news/highlights-management-board-october-2021-meeting

https://www.swissmedic.ch/swissmedic/fr/home/medicaments-a-usage-humain/essais-cliniques/essais-cliniques-de-medicaments/soumission-de-changements-pendant-la-realisation-dun-essai-clini.html

https://admin.ich.org/sites/default/files/2021-09/ICHImplementationPublicReport_2021_0909.pdf

https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-september-2021

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf

Lignes directrices (version 08/2021)