Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Marriott Wardman Park Hotel

Jan 26, 2020 9:00 AM - Jan 26, 2020 5:00 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

Short Course 1: Pharmacovigilance and Risk Management Planning


*Short Course requires separate registration

Short Course Registration: 8:00AM-5:00PM

This full-day 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 healthcare 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.

Lunch is included with this Short Course.

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

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.