Q&A: Good clinical practice (GCP) 18 January 2024 All news https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/qa-good-clinical-practice-gcp
Work plan for the Pharmacovigilance Inspectors’ Working Group for 2024-2026 15 January 2024 All news EU-work-plan-pharmacovigilance-inspectors-working-group-phv-iwg-2024-2026_10Jan2024-1Download
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024 12 January 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2024
Midterm report on 2025 network strategy highlights good progress during critical period of the pandemic 5 January 2024 All news https://www.ema.europa.eu/en/news/midterm-report-2025-network-strategy-highlights-good-progress-during-critical-period-pandemic
Hemovigilance: ANSM changes the way blood donors report adverse events 2 January 2024 All news https://ansm.sante.fr/actualites/hemovigilance-lansm-fait-evoluer-la-declaration-des-effets-indesirables-donneurs-de-sang
Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation Version 2 29 December 2023 All news EU-Guidance-for-the-Transition-of-Clinical-Trials-from-the-Clinical-Trials-Directive-to-the-Clinical-Trials-Regulation-Version-2-21-Dec-2023_22Dec2023-1Download
Artificial intelligence workplan to guide use of AI in medicines regulation 26 December 2023 All news https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation 21 December 2023 All news EU-Regulation-EU-2017-745-Questions-and-answers-regarding-clinical-investigation-December-2023Download
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) 18 December 2023 All news https://www.ema.europa.eu/en/documents/other/questions-and-answers-describing-adverse-events-product-information-summary-product-characteristics-spc-and-package-leaflet-pl_en.pdf
