Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024
The list of “never events” is now updated
https://ansm.sante.fr/actualites/la-liste-des-never-events-est-actualisee
Annual report highlights progress in science, medicines and health in 2023
https://www.ema.europa.eu/en/news/annual-report-highlights-progress-science-medicines-health-2023
European regulation on medical devices: end of transition period
https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
Certification of medical devices: a second European notified organization for France
https://ansm.sante.fr/actualites/certification-des-dispositifs-medicaux-un-deuxieme-organisme-notifie-europeen-pour-la-france
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2024
United Kingdom – Guidance: Send and receive information on adverse drug reactions (ADRs)
https://www.gov.uk/guidance/send-and-receive-information-on-adverse-drug-reactions-adrs
Quick guide – Transitional trials from EudraCT to CTIS (sponsor users)
https://www.ema.europa.eu/en/documents/other/sponsors-guide-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf