Adverse Drug Events in Premarketing Clinical Trials and Postmarketing Pharmacovigilance

Venue: Sheraton Philadelphia City Center Hotel

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Sep 18, 2008 End Date/Time: Sep 19, 2008
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For those new to pharmaceutical safety, discuss a range of topics related to premarketing clinical trials and postmarketing pharmacovigilance

•US and EU Regulations for Clinical Trial Safety and Postmarketing Pharmacovigilance
o Overview, Structure and Function of FDA, EMEA, ICH, and CIOMS
o US Pre- and Postmarketing Safety Regulations
•Clinical Trials, Observational Studies, and MedDRA®
o EU and Japan Pre- and Postmarketing Safety Regulations
o Seriousness
o Expectedness
o Design and Conduct of Observational Studies
o MedDRA® Terminology and Coding
o Panel Discussion: Integrating Safety Reporting Requirements within Pre- and Postmarketing Clinical Studies

• Pre- and Postmarketing Adverse Events, Statistical Considerations, and Special Clinical Trial Topics
o The Clinical Pharmacological Basis for Adverse Events
o Assessment of Individual Case Study Reports (ICSRs)
o Crafting Quality Narratives
o From Individual Case Data to Aggregate Safety Information
o DSMBs, IRBs, and Unblinding
• Management and Minimization of Medical Product Risk
o Pharmacovigilance Planning: The E2E Guideline
o Risk Management in Premarketing Clinical Safety and Postmarketing Pharmacovigilance
o Panel Discussion: The Pre- and Postmarketing Risk Management Continuum: A Brave New World

This Program was Developed by the Clinical Safety and Pharmacovigilance Special Interest Area Community.