Crowne Plaza de Mexico, Mexico City, Mexico
Sep 2 2011 8:30AM - Sep 3 2011 2:45PM
Learn the key tools available for pharmacovigilance, discuss their current application,and consider future directions of the field. The focus will be on marketed biopharmaceutical products in a global context. What You Will Learn • Perspectives on the importance of pharmacovigilance, technovigilance, and vaccine vigilance • Basics of US, European, and other global requirements for postmarketing drug safety • Organisational aspects to consider in the context of pharmacovigilance obligations • A day in the life of an Individual Case Safety Report • How to speak the language of your pharmacovigilance colleagues • Risk management and minimisation plans and their importance • Why to consider pharmacovigilance audits and inspections in the context of SOPs, training, and documentation • Predictions on the future of drug safety and pharmacovigilance
Learning Objectives:
At the conclusion of this course, participants should be able to: • Identify the high-level ethical, legal, and regulatory basis for postmarketing medical product safety • Describe at least three historical scenarios that have strengthened the pharmacovigilance system • Explain current global requirements and challenges for case processing and aggregate reporting • Outline US and EU regulatory requirements for Risk Management Plans and Risk Evaluation and Mitigation Strategies • Assess how their organisation’s pharmacovigilance system might perform in an audit or inspection • Apply principles learned to make their organisation’s pharmacovigilance unit more efficient, strengthen compliance, and better protect patient safety
Event Code:
11921
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