![]() ![]() Proactive pharmacovigilance pre- and post-marketingĪnticipating drug safety issues in the development of small molecules and biologics ![]() New electronic reporting standards, E2B (R3), IDMP Stakeholder involvement initiatives such as PROTECT, WEB-RADR Public hearings including first EMA hearing - September 2017 Periodic reports and signal management and use of EudraVigilance Quality management systems and the pharmacovigilance system master file (PSMF)Įxpedited reporting: solicited vs spontaneous The role of the Pharmacovigilance Risk Assessment Committee (PRAC) and SCOPE initiative Inspections and penalties for non-complianceĮuropean post-marketing pharmacovigilance regulations Implications for the global environment - the links to ICH and CIOMS recommendations Overview of European regulatory framework, including 2012 EU pharmacovigilance legislation The current regulatory framework and its global impact Medical evaluation of individual reports of adverse events The principles of causality assessment with practical examples Risk management and risk minimisation: basic principlesĬausality assessment: clinical diagnosis of adverse events Principles of pharmacovigilance and data resourcesīasic principles of monitoring drug safetyĭata resources available for monitoring and evaluating drug safety There will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance your understanding of pharmacovigilance issues. Our panel of experts will offer practical guidance throughout the course and use real-world examples and case studies to contribute to the development of your knowledge. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments, and effective signal detection. 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. This comprehensive three-day course has been designed to provide an introductory guide for all those concerned with pharmacovigilance. 08, 2021 (GLOBE NEWSWIRE) - The "Pharmacovigilance Training Course" conference has been added to 's offering. ![]()
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