ANSM Annual Report 2023
https://ansm.sante.fr/qui-sommes-nous/publications-institutionnelles/rapport-dactivite-2023/p/2023-en-bref#title
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-september-2024
Harnessing AI in medicines regulation: use of large language models (LLMs)
https://www.ema.europa.eu/en/news/harnessing-ai-medicines-regulation-use-large-language-models-llms
Good pharmacovigilance practices (GVP) – Guideline updates
Updates: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions Guideline on good pharmacovigilance practices (GVP)…
European regulations on medical devices and in vitro diagnostics: publication of a consensus statement for the European Commission
https://ansm.sante.fr/actualites/reglements-europeens-relatifs-aux-dispositifs-medicaux-et-de-diagnostics-in-vitro-publication-dun-consensus-statement-a-destination-de-la-commission-europeenne
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024