The Workshop

Pre-conference Morning Workshop
Tuesday 17 June 2008	Led by: Joerg Seebeck Senior Medical Director and Victor A Kiri Director of Pharmacoepidemiology Parexel	Pharmacovigilance and pharmacoepidemiology as partners in the development and implementation of effective RMPs
Workshop Agenda
09:00	Delegate registration and coffee
09:30	Importance of pharmacoepidemiological studies within the EU Pharmacovigilance System- types of PE-studies
10:20	Importance of pharmacoepidemiological studies within the EU Pharamcovigilance System - uses of PE- studies Detection/quantification of risks Supply control (registries) Drug utilisation Assessment of risk minimisation
11:10	Morning refreshments
11:30	Importance of pharmacoepidemiological studies within the EU Pharmacovigilance System: the regulatory framework with examples of practical application
12:30	Close of workshop
About the Workshop leaders
Dr Seebeck	Dr Seebeck (MD) is a Senior Medical Director at PAREXEL with specialist degrees in General & Clinical Pharmacology. He led a dedicated group of physicians responsible for assessing Risk Management Plans and Post-Authorisation Safety Studies at the Department of Pharmacovigilance, Federal Institute for Drugs and Medicinal Devices in Germany (2001-2007).
Prof Kiri	Prof Kiri (PhD) who is director of Pharmacoepidemiology in PAREXEL has almost 20 years experience on epidemiological studies, over 8 years within the industry. He is a member of the International Society of PharmacoEpidemiology and appears in the Marquis Who’s Who in Medicine & Healthcare as a leading Pharmacoepidemiologist.



Pre-conference Afternoon workshop
Tuesday 17 June 2008	Led by: Brian Edwards Director, Pharmacovigilance and Drug Safety NDA Regulatory Service	Systems-based solutions for compliance and safety: the key to managing risk
Workshop agenda
13:30	Delegate registration and coffee
14:00	Sessions will explore the following key issues: Creating a pharmaceutical “culture of safety “ Why the pharmaceutical industry is struggling to restore the public's trust Continuous evidence of safety problems even amongst the best organisations Adopting Crew Resource Management (CRM), a systems approach to safety and operational risk management
15:30	Afternoon refreshments Harnessing the insights of management and staff engaged in the work process Adapting into a set of productivity enhancement skills and tools Combining and integrating safety technologies to create a systematic methodology to generate a sustainable culture for the pharmaceutical sector
17:00	Close of workshop
About the workshop leader
Dr. Edwards	Prior to joining NDA, Dr. Edwards has been in senior medical positions at Johnson & Johnson and at Parexel International. His responsibilities included QP for pharmacovigilance, pre- and post-marketing pharmacovigilance, risk-benefit assessment, crisis management, and consulting advice about pharmacovigilance strategy, processes and implementation. Until 1999, Dr. Edwards was a Senior Medical Assessor in the Pharmacovigilance Assessment Group, Medicines Control Agency (MCA), in the UK where he was responsible for the assessment of a variety of different major drug/vaccine safety issues. Dr. Edwards holds a Doctor of Medicine degree from the University of London, Guy’s Hospital Medical School. He is Treasurer and member of the Executive Committee for the International Society of Pharmacovigilance, European chair of the Clinical Safety and Pharmacovigilance (CSP) SIAC for DIA, and the CSP representative on the European Steering Committee for DIA (ACE). Dr. Edwards chairs the panel, appointed by the UK Faculty in Pharmaceutical Medicine, overseeing the Drug Safety Surveillance module as part of Higher Medical Training for pharmaceutical medicine in the UK.