Taking into account the implementation experience with GVP module VI, which came into force on 2 July 2012, this tutorial will focus on frequently asked questions from stakeholders with regards to the day-to-day operational aspects.

In addition, practical considerations on the update of GVP module VI focusing on a simplification of the reporting of suspected adverse reactions from non-interventional post-authorisation studies, compassionate use and patient support programmes will be addressed.

At the start of 2015, the European Medicines Agency will launch a 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 first experiences of marketing authorisation holders (MAHs) and to address specific implementation questions.

Article 24 of Regulation 726/2004 also outlines a new approach for marketing authorisation holders 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 will be updated to define the data elements of Individual Case Safety Reports (ICSR) for which access can be provided in compliance with EU personal data protection legislation. The tutorial will provide an opportunity to discuss those data elements in support of the marketing authorisation holders’ pharmacovigilance obligations.  

The tutorial will conclude with a detailed discussion of the reporting principles in line with the new ICH Individual Case Safety Report E2B (3) guideline thereby highlighting new concepts such as causality assessment at event level, drug reaction relatedness, amendment reports and reporting of special situations (e.g. counterfeit medicines, product defects, medication errors).