Postmarketing Drug Safety & Pharmacovigilance

Date(s) And Time(s):
Oct 26 2011 8:00AM - Oct 27 2011 5:00PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

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
• 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:

Contact Information:

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Course