Tutorial 01: Highlights on the Implementation of the New Pharmacovigilance Legislation with regards to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in Eudravigilance

Following publication of the new pharmacovigilance legislation in December 2010, the Commission’s Implementing Measures for the performance of pharmacovigilance activities and the Good Pharmacovigilance Practices (GVP) replacing Volume 9A bring significant changes to the conduct of pharmacovigilance. Furthermore, the new ICH Individual Case Safety Report (ICSR) Implementation Guide will introduce substantial modifications to the format and content of electronic adverse reaction reporting. These changes have a big impact on the operational procedures and the day to day activities of stakeholders working in pharmacovigilance. This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules and the strengthening of the EudraVigilance System to improve transparency, data quality and to support signal detection and management activities in the EU. In addition, specific emphasis will be put on informing, explaining and helping stakeholders as how to apply the new rules taking into account the international standardisation and harmonisation activities and data privacy challenges.

 Qualified Persons Responsible for Pharmacovigilance
 Staff involved in:

• Pharmacovigilance in companies and National Competent Authorities
• Clinical Data Management
• Regulatory intelligence
•  Information management
•  Safety databases
  

At the conclusion of this tutorial, participants will be able to:

• Understand the adverse reaction reporting rules described in the new pharmacovilance legislation
• Describe the new international standards and terminologies for reporting to EudraVigilance
• Describe the obligations for marketing authorisation holders regarding signal detection and management