PRAC recommendations on safety signals 27 November 2023 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
Getting ready for EMA’s website relaunch on 5 December 2023 23 November 2023 All news https://www.ema.europa.eu/en/news/getting-ready-emas-website-relaunch-5-december-2023
Joint Action on Market Surveillance (JAMS) 2.0: Europe meets ANSM on 14 and 15 November 2023 20 November 2023 All news https://ansm.sante.fr/actualites/joint-action-on-market-surveillance-jams-2-0-leurope-a-lansm-les-14-et-15-novembre-2023
Questions and Answers on FDA’s Adverse Event Reporting System (FAERS) 16 November 2023 All news USA-Questions-and-Answers-on-FDAs-Adverse-Event-Reporting-System-FAERS-_-FDA_08Nov2023-1Download
A joint effort to prevent the misuse of medicines 13 November 2023 All news https://ansm.sante.fr/actualites/un-engagement-de-tous-les-acteurs-pour-lutter-contre-le-mesusage-des-medicaments
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023 10 November 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-6-9-november-2023
Denmark-Questions and Answers on the National Implementation of the EU Clinical Trials Regulation 7 November 2023 All news https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/new-european-clinical-trial-regulation-from-the-31th-january-2022/
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 2 November 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2023
Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 28-31 August 2023 30 October 2023 All news EU-minutes-prac-meeting-28-31-august-2023_27Oct2023-1Download
Early access to medicines: a positive assessment after two years of implementation 27 October 2023 All news Acces-precoce-des-medicaments-un-bilan-positif-apres-deux-ans-de-mise-en-place-du-dispositif-1Download
