Highlights of Management Board – October 2021 meeting
https://www.ema.europa.eu/en/news/highlights-management-board-october-2021-meeting
Submission of changes during the clinical trial and reporting on ongoing clinical trials
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/submission-of-changes-during-the-trial.html
Monitoring implementation and adherence to ICH guidelines
https://admin.ich.org/sites/default/files/2021-09/ICHImplementationPublicReport_2021_0909.pdf
NHS – Safety reporting – UK
https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-september-2021
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-august-2-september-2021
Artificial intelligence in medicine regulation – EMA
https://www.ema.europa.eu/en/news/artificial-intelligence-medicine-regulation
