Benefit-Risk Assessment for New Drug and Biological Products – Guidance for Industry 23 October 2023 All news USA-Guidance-for-Industry-Benefit-Risk-Assessment-for-New-Drug-and-Biological-Products-19Oct-2023-1Download
EMA – Mid-year report 2023 20 October 2023 All news EU-european-medicines-agency-mid-year-report-2023-january-june-2023_18Oct2023-1Download
ANSM – Summary of the 2022 Activity Report 16 October 2023 All news https://ansm.sante.fr/syntheseRA2022FR/index.html#page/1
Feedback on the October 2023 PRAC (25 – 28 September) 13 October 2023 All news https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-doctobre-2023-25-28-septembre
Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting on 03-06 July 2023 9 October 2023 All news EU-minutes-prac-meeting-3-6-july-2023_25Sep2023-1Download
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
