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
EMA: Minutes of PRAC meeting on 26 – 29 September 2022 20 February 2023 All news EU-Minutes-of-PRAC-meeting-on-26-29-September-2022-1Download
Human medicines: highlights of 2022 17 February 2023 All news https://www.ema.europa.eu/en/news/human-medicines-highlights-2022
EMA list of frequently asked questions 13 February 2023 All news EU-Frequently-asked-questions-_-EMA_Feb2023-2Download
Welcome to the team! 9 February 2023 All news The Pharmya Team is happy to welcome Manel, our new PV Expert trainee!
The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU) 6 February 2023 All news https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substance-product-data-management-services?fbclid=IwAR2n_D1C_FF0oRphglmchOODcHaeMU-9JxVlSRp4FrBuuBLdSePYAl-Utd8
