Premarketing Clinical Safety & Pharmacovigilance

Venue: Drug Information Association, Inc

Location: Horsham, Pennsylvania, United States

Event Date/Time: Mar 21, 2011 End Date/Time: Mar 22, 2011
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What you will learn
• Fundamental concepts of drug safety and pharmacovigilance and their application to clinical development
• How to comply with FDA and European regulations for clinical safety
• How to pass a preapproval safety inspection
• Proven concepts of premarketing risk assessment and its important role in the development of Risk Evaluation and Mitigation Strategies (REMS)
• How to effectively use signaling tools and techniques to support premarketing risk assessment

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Discuss why premarketing clinical safety and pharmacovigilance is important to ensure Good Pharmacovigilance Practice
• Explain the requirements of FDA and European regulations for premarketing clinical safety and pharmacovigilance
• Prepare for a preapproval inspection for clinical safety
• Develop company policies and procedures for clinical safety
• Perform a premarketing risk assessment

Target Audience:
Professionals involved in:
• Clinical safety and Pharmacovigilance
• Clinical development
• Regulatory affairs
• Quality management


Enterprise Drive
United States