Postmarketing Drug Safety & Pharmacovigilance

Venue: Drug Information Association, Inc

Location: Horsham, Pennsylvania, United States

Event Date/Time: Oct 26, 2011 End Date/Time: Oct 27, 2011
Report as Spam


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
• Describe how your drug safety system will perform 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.
• Discuss 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
• Describe 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:


Enterprise Drive Suite 200
United States