Pre-marketing Clinical Safety & Pharmacovigilance

Venue: Drug Information Association, Inc

Location: Horsham, Pennsylvania, United States

Event Date/Time: Nov 15, 2010 End Date/Time: Nov 16, 2010
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Description

Fundamental Concepts of Clinical Safety
Learn how to comply with FDA and European regulations for clinical safety.

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 regulation 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

Event Code:
10438

Venue