Regulatory News - October 2017

EMA Policy update
An update to the EMA Policy on the publication of clinical data for medicinal products for human use was published on the 22nd of September and is available here.
This document provides guidance on the procedural aspects of the submission of clinical reports, the anonymization of clinical reports, and the identification and reduction of commercially confidential information in clinical reports.

The 11th stakeholder forum on pharmacovigilance legislation (21/09/2017)
This forum brings together regulators with patients, healthcare professionals, and industry. The agenda for this event is available here. Presentations and video recording will be made available here.

Periodic Safety Update Reports (PSUR) roadmap: A joint industry/assessor training (22/09/2017) - broadcast
This joint industry/assessor PSUR training broadcast is aimed at achieving a common understanding of the role of PSURs in a product’s lifecycle. Topics covered include signals, close monitoring, safety specification, product information/reference safety information, and the use of summary tabulations. The video recording of the event will be made available here.

EMA’s first public hearing on valproate (27/09/2017) - broadcast
European citizens representing patients, carers, healthcare professionals, and academia shared their experience with valproate. The agenda for this event is available here. Further information is available here.