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Bethesda North Marriott Hotel and Conference Center

Feb 05, 2023 9:00 AM - Feb 05, 2023 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course: Pharmacovigilance and Risk Management Planning

This is a In-Person Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference


*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

Receive $150 off your Global Pharmacovigilance and Risk Management Conference registration by registering for at least two short courses and the main conference. Purchases must be made at the same time to receive the discount. Discount will be reflected on the last page of the cart.

This full-day in-person short course 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 focus will be on the EU, UK, US and Canada situations, but this will be supplemented with experience gained in other selected jurisdictions.

Learning objectives

Upon completing this course, attendees will be able to:
  • 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 the importance of the pharmacovigilance plan
  • Compare the differences between routine and additional risk minimization activities
  • Identify similarities and differences in risk management planning in the three ICH regions and other selected jurisdictions
  • Discuss 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

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