Commonwealth Informatics

By Paul Barrow, Associate Director, Commonwealth Informatics

This November marked a significant change for signal management following the EU pharmacovigilance legislation with Marketing Authorisation Holders (MAHs) receiving access to EudraVigilance data for signal detection for the first time.

MAHs will be granted access starting in December.  A one-year pilot starts three months later on 22 February 2018 when MAHs are required for to perform signal detection for a limited set of products.  Continue reading Preparing for EudraVigilance Monitoring

Date posted: December 15, 2017 | Author: | No Comments »

Categories: EudraVigilance pharmacovigilance