Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 – 8 June 2023 12 June 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-june-2023
The European Commission and WHO launch landmark digital health initiative to strengthen global health security 9 June 2023 All news https://www.who.int/news/item/05-06-2023-the-european-commission-and-who-launch-landmark-digital-health-initiative-to-strengthen-global-health-security
Decision of 22/05/2023 defining the form, content and procedures for the reporting of adverse events and new developments in the field of research mentioned in research mentioned in 1° of Article L. 1121-1 of the French public health code concerning medicinal products for human use. 5 June 2023 All news https://ansm.sante.fr/actualites/decision-du-22-05-2023-fixant-la-forme-le-contenu-et-les-modalites-des-declarations-deffets-indesirables-et-des-faits-nouveaux-dans-le-cadre-de-recherche-mentionnee-au-1deg-de-larticle-l-1121-1-du-csp-portant-sur-un-medicament-a-usage-humain
FAQ for the webinar on the new European legislation on clinical trials for medicinal products 30 May 2023 All news https://ansm.sante.fr/documents/reference/reglementation-relative-aux-essais-ou-investigations-cliniques/faq-du-webinaire-dedie-au-nouveau-reglement-europeen-des-essais-cliniques-de-medicaments
EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12 May 2023 25 May 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-12-may-2023
EMA – Annual Report 2022 23 May 2023 All news https://www.ema.europa.eu/en/news/ema-annual-report-2022-published
EU – Quick guide on Clinical trials regulation 15 May 2023 All news Quick-guide-Clinical-trials-regulation-No-536-2014-Eudralex-Volume-10-1Download
EMA: Minutes of PRAC meeting on 09 Jan to 12 Jan 2023 11 May 2023 All news EMA-minutes-prac-meeting-9-12-january-2023_en-03May2023-1Download
Reporting a quality defect on a medicine 9 May 2023 All news Signaler-un-defaut-qualite-sur-un-medicament-ANSM_04May2023-1Download
Frequently Asked Questions: Revision of the Pharmaceutical legislation 4 May 2023 All news QA_-Revision-of-the-Pharmaceutical-legislation_27Apr2023-1Download