L’application du Règlement UE n° 536/2014 impose de nouvelles modalités de travail pour les autorités compétentes et les Comités d’éthique des Etats membres. Son entrée en vigueur interviendra au plus tôt le 28 mai 2016, sous réserve de la mise…

The EMA releases an updated version of the GVP Module IV, Pharmacovigilance audits. Changes include: Addition of an explanatory note for the definition of audit in footnote 3 on page 5; Editorial improvements in line with the overall GVP style.…

Publié par  J Clin Oncol, 26 Janvier 2015 Les auteurs en concluent que la collecte des données de tolérance dans les essais cliniques pourrait également intégrer un recueil en provenance des patients (en plus des données médicales). Voir article 

Published by EMA, Feb 2015 The EMA has recently published some presentations explaining how to submit PSURs to the PSUR Repository. Existing gateway users New gateway Users

On 16 September 2014, a new revision of Module III on Pharmacovigilance Inspections came into effect. GVP Module III has now been revised to include reference to the new EU procedure on the coordination of pharmacovigilance inspections, which came into…

Published by FDA on 10-Jun-2014 This is one in a series of guidance documents intended to assist applicants making certain regulatory submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation…

Published by EMA on 19-Jun-2014 As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). This date corresponds to the finalisation of…

Published by EMA on 05-May-2014 In March 2014, the Agency began publishing summaries of RMPs for centrally authorised medicines. These are intended to allow stakeholders wider access to the information behind the decision-making process of European regulatory authorities when they review the safety…