E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files 19 April 2022 All news https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files
CLINICAL TRIALS REGULATION (EU) NO 536/2014 – QUESTIONS&ANSWERS VERSION 6 15 April 2022 All news EU-regulation-536-2014-QA_version-6_Apr2022-1Télécharger
New EU regulation on clinical trials of medicinal products 11 April 2022 All news https://ansm.sante.fr/actualites/entree-en-application-du-nouveau-reglement-europeen-relatif-aux-essais-cliniques-des-medicaments
Reporting safety information on clinical trials 8 April 2022 All news https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/reporting-safety-information-clinical-trials
List of medicines under additional monitoring 4 April 2022 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 06-09 April 2022 31 March 2022 All news https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-6-9-april-2021_en.pdf
Meeting highlights from the Committee forMedicinal Products for Human Use (CHMP)21-24 March 2022 28 March 2022 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-march-2022
EMA EudraVigilance Registration Manual 25 March 2022 All news https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-registration-manual_en.pdf
EMA Management Board: highlights of March 2022 meeting 21 March 2022 All news https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2022-meeting
PRAC recommendations on safety signals 18 March 2022 All news https://www.ema.europa.eu/documents/prac-recommendation/prac-recommendations-signals-adopted-7-10-february-2022-prac-meeting_en.pdf
