Key performance indicators (KPIs) to monitor the European clinical trials environment 1 July 2022 All news key-performance-indicators-kpis-monitor-european-clinical-trials-environment-1-31-may-2022-edition-2_en-1Télécharger
EU-Meeting highlights from the CHMP 20-23 June 2022 27 June 2022 All news EU-Meeting-highlights-from-the-CHMP-20-23-June-2022-1Télécharger
Switzerland : Notification of Quality Defects 24 June 2022 All news Switzerland-Notification-of-Quality-Defects_23May2022-2Télécharger
Australia : Beta version of the Database of Adverse Event Notifications (DAEN) for medicines launched 20 June 2022 All news Australia-Beta-version-of-the-Database-of-Adverse-Event-Notifications-DAEN-for-medicines-launched-_8Jun2022-1Télécharger
Belgium : Request to marketing authorisation holders to send the approved version of the riskmanagement plan 17 June 2022 All news Belgium-Request-to-MAHs-to-send-the-approved-version-of-the-RMP_FAMHP_07Jun2022-1Télécharger
Clinical Trials Regulation (EU) N° 536/2014 version 6.1 – Q&A 13 June 2022 All news EU-QA-regulation536-2014_v6.1_May2022-2Télécharger
New version of the French Good Pharmacovigilance Practices 7 June 2022 All news France-BONNES-PRATIQUES-DE-PHARMACOVIGILANCE-MAY-2022-1Télécharger
EU_EMA_PSUR eSubmission 3 June 2022 All news european-medicines-agency-PNG-7Télécharger EU_EMA_PSUR-eSubmission_-Projects_24May2022-2Télécharger
Authorisation for early access to medicines: HAS evaluation doctrine 30 May 2022 All news France_acces_precoces_-_doctrine_27Apr2022-1Télécharger
China : release of MedDRA Coding Guidance for Adverse DrugReaction (ADR) Reports 23 May 2022 All news https://baipharm.chemlinked.com/news/china-releases-meddra-coding-guidance-for-adverse-drug-reaction-adr-reports
