Minutes of PRAC meeting on 10-12 May 2023 1 September 2023 All news EU-Minutes-of-PRAC-meeting-on-10-12-May-2023-1Download
Minutes of the meeting of the Standing Scientific Committee on Surveillance and Pharmacovigilance on 9 May 2023 29 August 2023 All news France-Permanent-Scientific-Surveillance-and-Pharmacovigilance-Committee-Signal_Minutes-of-the-Meeting-of-09-May-2023_published-21Aug2023-1Download
Q&A: Good clinical practice (GCP) 24 August 2023 All news https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp
Clinical Trial Information System (CTIS) Newsflash – 18 Aug 2023 21 August 2023 All news EU-ctis-newsflash-18-august-2023-1Download
Scientific advice and protocol assistance 18 August 2023 All news https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance
The ANSM renews its standing scientific committees 14 August 2023 All news https://ansm.sante.fr/actualites/lansm-renouvelle-ses-comites-scientifiques-permanents
Paving the way towards coordinated clinical trials in public health emergencies in the EU 11 August 2023 All news https://www.ema.europa.eu/en/news/paving-way-towards-coordinated-clinical-trials-public-health-emergencies-eu
PRAC recommendations on signals – Adopted at the 3-6 July 2023 PRAC meeting 7 August 2023 All news EU-prac-recommendations-signals-adopted-3-6-july-2023-prac-meeting_31July2023-1Download
Early access to medicinal products 3 August 2023 All news https://www.has-sante.fr/jcms/r_1500918/en/early-access-to-medicinal-products
Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation 31 July 2023 All news EU-Guidance-for-the-transition-of-clinical-trials-form-directive-to-regulation_19July2023-1Download