EU: Marketing Authorization Holders involved in GMP, GCP and GVP inspections coordinated by EMA 19 December 2022 All news EU-mahs-involved-gmp-gcp-gvp-inspections-coordinated-ema_Dec2022-1Télécharger
EU: meeting highlights from the CHMP 16 December 2022 All news EU-Meeting-highlights-from-the-CHMP-12-15-Dec2022-1Télécharger
Australia: Pharmacovigilance Inspection Program 5 December 2022 All news Australia_Pharmacovigilance-Inspection-Program-_-Therapeutic-Goods-Administration-TGA_30Nov2022-2Télécharger
Clinical Trials Information System (CTIS) 2 December 2022 All news EU-CTIS-Sponsor-Handbook-2022_v.3_29Nov2022-2Télécharger
Austria: FAQ Pharmacovigilance – 22-Nov-2022 28 November 2022 All news Austria_FAQ-pharmacovigilance-BASG_22Nov2022-1Télécharger
Benfluorex: assessment of the follow-up of cases of pulmonary arterial hypertension 25 November 2022 All news https://ansm.sante.fr/actualites/benfluorex-bilan-du-suivi-des-cas-dhypertension-arterielle-pulmonaire
EU : List of centrally authorised products requiring a notification of a change for update of annexes 18 November 2022 All news EU-list-centrally-authorised-products-requiring-notification-change-update-annexes_15Nov2022-2Télécharger
Germany: Compassionate Use Programmes_28-Oct-2022 14 November 2022 All news Germany_Compassionate-Use-Programmes-PEI_28Oct2022-1Télécharger
