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Tutorial #1 – Pharmacovigilance and Risk Management Planning

Jan 12 2014 8:30AM - Jan 12 2014 12:00PM | Renaissance Washington DC Downtown Hotel 999 Ninth Street NW Washington, DC 20001

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This tutorial will focus on the practical aspects of managing biopharmaceutical product risks in the context of a product’s benefits.

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Discuss similarities and differences in risk management planning in the three ICH regions
  • Describe the differences between important identified risks and important potential risks
  • Outline the basic structure and contents of an EU Risk Management Plan (in the context of a Risk Management System) and a Risk Evaluation and Mitigation Strategy (REMS)
  • Discuss primary tools for managing product risks, how the effectiveness of a selected tool is assessed, and triggers for modification or removal of a given intervention


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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.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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