This tutorial will focus on the following key topics: Revision of the EudraVigilance Access Policy, medical literature monitoring by the agency, implementation of the ISO/ICH E2B(R3) ICSR, and FAQs related to GVP Module VI.

Article 24 of Regulation (EC) 726/2004 outlines a new approach for marketing authorisation holders (MAHs) to access EU adverse reaction reports directly in EudraVigilance, following the successful outcome of an audit of the European pharmacovigilance database. In preparation of these changes, the EudraVigilance Access Policy has been revised to define how access will be provided to ICSR in compliance with EU personal data protection legislation.

Following the launch of the new process of monitoring medical literature for selected substances and selected medical literature in line with the provisions set out in Article 27 of Regulation 726/2004, the tutorial will provide the opportunity to discuss experiences and to address specific implementation questions.

The implementation of the ISSO ICSR/ICH E2B(R3) guideline will be discussed, which requires IT and business changes for which stakeholders need to carefully plan and prepare.

;The tutorial will conclude with frequently asked questions with regards to the day-to-day operational aspects of GVP Module