Regulation on Clinical Trials (EU) N°536/2014 Questions and Answers 6 October 2023 All news EU-Updated-document-Questions-Answers-Clinical-Trials-Regulation-EU-No-5362014-29Sep2023-1Download
EMA – Risk management plans – Update 2 October 2023 All news EU-Risk-management-plans-_-European-Medicines-Agency-29Sep2023-1Download
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 29 September 2023 All news EU-Meeting-highlights-from-PRAC-25-28-September-2023-_-European-Medicines-Agency-29Sep2023-1Download
European contact points for clinical trials 25 September 2023 All news EU-Contact-points_clinical-trials_reg-536-2014_19Sep2023-1Download
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 21 September 2023 All news EU-Meeting-highlights-from-the-CHMP-11-14-September-2023-1Download
Clinical Trials Regulation (EU) No 536/2014 in practice 18 September 2023 All news EU-Clinical-Trials-Regulation-EU-No536_2014-in-practice_28Aug2023-1Download
Committee for medicinal products for human use (CHMP) – Minutes for the meeting on 19-22 June 2023 14 September 2023 All news EU-CHMP-Minutes-19-22-June-2023-1Download
United Kingdom – Pharmacovigilance Inspection Metrics Report April 2021 – March 2022 11 September 2023 All news UK-MHRA-GPvP-inspection-metrics-2021-22_FINAL-1Download
Innovation in medicines 8 September 2023 All news https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#itf-briefing-meetings–section
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023 4 September 2023 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-31-august-2023