Tutorial #1 – Pharmacovigilance and Risk Management Planning

Tutorial name:
Tutorial #1 – Pharmacovigilance and Risk Management Planning

Day & Time:
January 12, 8:30AM - 12:00PM

Registration Fees
- Tutorial #1 Rate$405.00


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

EventCredit TypeMax CreditsCEU
Tutorial #1 – Pharmacovigilance and Risk ManagemeACPE
IACET
RN
3.25
3.25
3.25
0.325
0.300
0.000


Learning Objective(s):

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