UK: Guidance on pharmacovigilance procedures 7 November 2022 All news UK_Guidance-on-pharmacovigilance-procedures-GOV.UK_28Oct2022-1Télécharger
EU: minutes of the CHMP meeting_12-15 september 2022 4 November 2022 All news https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-12-15-september-2022_en.pdf
Switzerland : Inspection of the Pharmacovigilance-System in GMP/GDP Inspections 31 October 2022 All news Switzerland_i-smi_ll_11e_inspectionofpharmacovigilance-systemguideline_17Oct2022-1Télécharger
Belgium-Unmet Medical Need FAQ 28 October 2022 All news Belgium-Unmet-Medical-Need-FAQ_1.14_18Oct2022-1Télécharger
Denmark : Clinical trials – Questions and answers 25 October 2022 All news Denmark-Clinical-trials-QA_updated-07Oct2022-2Télécharger
Asutralia : Pharmacovigilance obligations of medicine sponsors 21 October 2022 All news Australia-Pharmacovigilance-obligations-of-medicine-sponsors-_-17Oct2022-1Télécharger
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)10-13 October 2022 17 October 2022 All news EU-Meeting-highlights-from-the-CHMP_10-13-October-2022-1Télécharger
EU : Q&A: Good clinical practice (GCP) 14 October 2022 All news EU-EMA-QA_-Good-clinical-practice-_-updated-Oct2022-2Télécharger
EU: Explanatory note on pharmacovigilance fees payable to the European Medicines Agency 10 October 2022 All news EU_explanatory-note-pharmacovigilance-fees-payable-ema-3-october-2022_en_03Oct2022-1Télécharger
France : Application for early access authorisation 7 October 2022 All news France-Demande-dautorisation-dacces-precoce-ANSM_06Oct2022-1Télécharger