WHO Pharmaceuticals Newsletter 23 March 2023 All news ICH-WHO-pharmaceuticals-newsletter-No.-1-2023_13-Mar-2023-1Download
Standing Scientific Committee on Surveillance and Pharmacovigilance – Restricted Expertise Session of 15 November 2022 minutes 20 March 2023 All news FRANCE-Permanent-Scientific-Surveillance-and-Pharmacovigilance-Committee-Restricted-Training-Expertise-Minutes-of-the-Meeting-of-15-Nov-2022_Published-on-13Mar2023-1Download
Guideline on computerised systems and electronic data in clinical trials 17 March 2023 All news EU-guideline-computerised-systems-electronic-data-clinical-trials_09Mar2023-1Download
EU-PRAC recommendations on signals adopted at the 6-9 February 2023 meeting 13 March 2023 All news EU-PRAC-recommendations-on-signals-adopted-at-the-6-9-February-2023-PRAC_06-Mar2023-1Télécharger
Welcome to the team! 9 March 2023 All news The Pharmya team is growing! A big welcome to Angélique, our new team assistant!
Letter to QPPVs – International Transfer of ICSRs from EV and GDPR 6 March 2023 All news 2022-12-Letter-to-QPPVs-International-Transfer-of-ICSRs-from-EV-and-GDPR-1Télécharger
Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) 3 March 2023 All news EU-questions-answers-query-management-working-group-ctis-ctr_Feb2023-1Download
List of medicines under additional monitoring 27 February 2023 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
USA: Electronic Submission to FAERS Using E2B(R3) Standards_17Feb2023 27 February 2023 All news USA-Electronic-Submission-to-FAERS-Using-E2BR3-Standards_17Feb2023-1Télécharger
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 – 23 February 2023 24 February 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-february-2023
