Premarketing Clinical Safety & Pharmacovigilance

Date(s) And Time(s):
Oct 24 2011 8:00AM - Oct 25 2011 4:00PM

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

Overview:

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 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

Event Code:
11423

Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org

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