Drug Information Association, Inc, Horsham, PA
Nov 17 2010 8:30AM - Nov 18 2010 5:00PM
An In-depth Look at Practical Solutions to Postmarketing Safety and Pharmacovigilance
Learn the key tools available for Pharmacovigilance, discuss their uses, and consider the future directions of the field. What you will learn
• How to make your Pharmacovigilance program more efficient and compliant
• US, European, and other global requirements and standards in drug safety and Pharmacovigilance
• Privacy, information technology, and data protection issues involved in drug safety
• How to speak the language of drug safety, signaling, risk management, and Pharmacovigilance
• The future of drug safety and Pharmacovigilance
• The basics of drug safety inspection
Learning Objectives:
At the conclusion of this course, participants should be able to:
• Identify the legal and regulatory basis of postmarketing drug safety and Pharmacovigilance
• Evaluate how your drug safety system will do on an audit or governmental inspection
• Explain the requirements, changes, pitfalls, and risks of drug safety and Pharmacovigilance, applying the knowledge gained in your daily Pharmacovigilance functions.
• Appraise US, EU, and other countries handling of expedited reports, ICSRs, aggregate reports, safety labeling, risk management, causality determination, signaling, audits and inspections, quality, compliance, IT, basic epidemiology, and more
• Analyze your company’s drug safety systems and determine whether they are meeting the needs and requirements
Target Audience:
Professionals involved 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 rapidly on the basics of drug safety and Pharmacovigilance
• Training and teaching of drug safety and Pharmacovigilance
• Clinical health care
• New drug development
• Outsourcing and offshoring of drug safety
• Supervising and dealing with drug safety
Event Code:
10440
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