QUESTIONSPostmarketing Drug Safety & Pharmacovigilance
Venue: Crowne Plaza de Mexico
Location: Mexico City, Mexico
| Event Date/Time: Aug 20, 2011 |
Report as SpamDescription
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:
11921
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:
11921
