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/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/submission-of-changes-during-the-trial.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
