Pharmacovigilance

This comprehensive three-day pharmacovigilance training course has been designed to provide an introductory guide for all those concerned with vigilance industry. The interactive programme will cover topics from basic pharmacovigilance principles and terminologies through to the current regulatory framework and its global impact, including drug surveillance in the EU, US and Japan. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments and effective signal detection.

Our panel of experts will offer practical guidance throughout the training course and use real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance your understanding of pharmacovigilance issues.

Key topics to be addressed include:

• Principles of pharmacovigilance and data resources
• Risk management, causality assessment and postauthorisation safety and efficacy studies (PASS/PAES)
• Pharmacoepidemiological studies and evolution of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and development safety update reports (DSURs)
• Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment
• Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe
• Drug surveillance in countries outside Europe
• Post-marketing surveillance: observational cohort studies
• An overview of signal detection and risk management plans (RMPs)