19th Annual Drug Information Association (DIA) EuroMeeting

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MEETING REPORT

© 2007 Adis Data Information BV. All rights reserved.

19th Annual Drug Information Association (DIA) EuroMeeting 26–28 March 2007; Vienna, Austria Mary Ellen Kitler Associates for Business and Research, Rolle, Switzerland

The Drug Information Association (DIA) annual EuroMeeting is the largest neutral, international, multidisciplinary forum dedicated to the global exchange of information across the full range of drug development and lifecycle management issues. There were approximately 2500 attendees from Europe and many corners of the globe, including South America, North America, the Middle East, India, Southeast Asia and China. The programme included more than 130 session topics and over 400 speakers, including representatives from the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the Austrian Agency for Medicinal Products and Medical Devices (AGES PharmMed). The 230 exhibitors included regulatory agencies and service companies offering a wide range of services, such as transport of clinical trial materials and biological samples, recruitment, biological and chemical analysis, statistical analysis and contract manufacturing. Thus, the exhibit provided participants with easy access to many potential suppliers and partners. 1. Improvement in the Research and Development Process: The Viewpoint from the EMEA and US FDA Regulatory agencies play a unique role in the development and validation of new tools to make better, more timely, decisions during the drug development process. Such tools should help make the development process more resource (human, time and financial) efficient. Thomas L¨onngren, Executive Director of the EMEA, discussed The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future.[1,2] The challenges to improving the research and development process include new technologies and

emerging therapies, such as gene therapy. The new developments must be addressed in the context of continuing globalisation. EMEA must help to stimulate innovation, research and development in the EU. The EMEA and the Heads of the National Medicines Agencies in the EU collaborated to develop the European Risk-Management Strategy (ERMS).[3] Currently, the EMEA and the National Competent Authorities are undertaking further work in context of the ERMS, in order to develop additional activities and implement the already agreed initiatives, which will lead to a more efficient system for supervising the safety of medicines. One of the main pillars of the ERMS is the EudraVigilance database and the submission of individual case safety reports (ICSRs). EMEA is currently organising the EU Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to monitor targeted medicines. The EMEA realises that it must improve the operating efficiency of the centralised approval procedure without compromising the quality of the assessment process that assures the safety of medicines that a