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Overview

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This full-day short course will be spread over three days and will focus on basic aspects of the regulatory framework for pharmacovigilance in the context of risk management planning and on the practical aspects of managing biopharmaceutical product risks in the context of benefits and the health care delivery system. The main focus will be on the EU and US situations, but this will be supplemented with experience gained in other selected jurisdictions.

Agenda for Short Course

Wednesday, January 20, 10:00 AM–12:00PM - Pharmacovigilance and Risk Management Planning Part 1

Thursday, January 21, 10:00AM–1:45PM - Pharmacovigilance and Risk Management Planning Part 2

Friday, January 22, 10:00AM–1:45PM - Pharmacovigilance and Risk Management Planning Part 3

Learning objectives

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

  • Discuss similarities and differences in risk management planning in the three ICH regions and other selected jurisdictions
  • 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 and non-routine tools for managing product risks, how the effectiveness of a selected tool is assessed, and points to consider for the modification, revision, or release of a given non-routine intervention