DIA, Horsham, PA USA
Mar 12 2012 8:00AM - Mar 13 2012 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 Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA. Event Code:
12414
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