Postmarketing Drug Safety & Pharmacovigilance

Venue: Crowne Plaza de Mexico

Location: Mexico City, Mexico

Event Date/Time: Aug 20, 2011
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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

Target Audience:

Professionals who work in:

• Global drug safety, pharmacovigilance, and risk management

• Regulatory and legal affairs

• CROs, start-ups, small companies, generic drug companies and anyone needing to get up to speed on the basics of drug safety and pharmacovigilance

• Training and teaching of drug safety and pharmacovigilance

• Clinical health care

• New drug development

• Outsourcing and off-shoring of drug safety

• Supervising and dealing with drug safety

• Risk evaluation, benefit-risk assessment, and benefit-risk communication

• Government Drug Regulatory Agencies

Event Code: