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Premarketing Clinical Safety & Pharmacovigilance

  May 30, 2011  
Drug Information Association, Inc, Horsham, PA USA
Oct 24 2011 8:00AM - Oct 25 2011 4:00PM

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

Event Code:
Organized by: DIA
Invited Speakers: See website for speaker information
Deadline for Abstracts: Call contact
Registration: Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108 
E-mail: colleen.buckley@diahome.org
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