The electronic transmission of ICSRs is a key element in improving the process of adverse reaction reporting in pharmacovigilance. It is not only a major step forward in providing information more rapidly but also in standardizing the way clinical safety data elements are presented, thereby improving the collective ability to evaluate complex data. The programme will address the latest status in the EEA regarding the electronic reporting initiatives from Regulator and Industry perspectives. The special areas that will be covered in depth are:
• An overview of the current implementation achievements
• The industry/sponsor perspective on the practical implementation aspects and operational concerns regarding the integration and use of the interdependent ICH E2B(M), M2, and M1 (MedDRA) guidelines and standards at Community level;
• The coordination of the implementation activities at Community level on the basis of the newly established EudraVigilance Expert Working Group and the EudraVigilance Steering Committee;
• The current achievements and the further developments of the EudraVigilance System in view of supporting the pharmacovigilance activities and risk management initiatives from the perspective of the EMEA;
• The lessons learned based on practical examples;
• Part III of the revised Volume 9A and the ‘Guidelines for Marketing Authorisation Holders, Competent Authorities and the Agency on the Electronic Exchange of Pharmacovigilance Information in the EU’; and
• The recent ICH initiatives with main focus on the revision of ICH E2B(M) guideline and the ICH M5 topic on data elements and standards for drug dictionaries related to core medicinal product information, as well as the ICH maintenance activities of controlled vocabularies.
Panel discussions will provide the opportunity for extensive Q&As with the experts.