Pharmacovigilance Programme Update / EMA October 2015
This 5th Update captures the important progress made in the development of the pharmacovigilance information systems and services. These systems will contribute to public health through optimisation of the safe and effective use of medicines. They should also facilitate pharmacovigilance,…
ANSM Lancement de la Phase Pilote / Nouveau règlement européen relatif aux essais cliniques
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…
GVP Module IV- Pharmacovigilance Audits
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.…
Effets indésirables et essais cliniques
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
How to submit PSURs to the EMA PSUR Repository?
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
Revision 1- GVP Module VI- Management and Reporting of Adverse Reactions to Medicinal Products
On 16 September 2014, a new revision of Module VI on Management and Reporting of Adverse Reactions to Medicinal Products came into effect. GVP Module VI has been revised to provide clarification on the clock start for reporting…
Revision 1- GVP Module III Pharmacovigilance Inspections released
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…
US- Draft Guidance_eSubmissions of ICSRs
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…
Sponsors must post clinical trial summaries in EudraCT as of 21 July 2014
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…