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Nov 05, 2018 8:15 AM - Dec 31, 2050 3:15 PM

Benefit-Risk Assessment and Management Across the Lifecycle


This course provides a comprehensive framework on benefit-risk of medicinal products. Participants will learn about the principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance. Fundamentals of benefit-risk assessment will be covered, including methods commonly used and incorporation of the patient perspective. Participants will be able to apply the key concepts learned to conduct a benefit-risk assessment and select tools to optimize benefit-risk balance. 

What you will learn

  • Legal and regulatory basis for benefit and risk obligations, including a historical perspective
  • Principles, basic definitions, and frameworks for compliance
  • Fundamentals of performing benefit-risk assessment
  • Importance of the patient perspective and incorporation into the benefit-risk equation
  • Risk minimization tools and the circumstances for which they are deployed
  • Measuring effectiveness of risk minimization
  • How and why the benefit-risk equation evolves over time
  • Benefit-risk assessment and selection of tools to minimize risks while maximizing benefit to the patient

Who should attend?

This program is designed for professionals involved in:

  • Drug safety and pharmacovigilance
  • Safety evaluation
  • Periodic safety reporting
  • Medical monitoring
  • Medical communication call centers
  • Medical writers
  • Regulatory strategy and regulatory affairs
  • Clinical research
  • Risk management planning and development of formal Risk Management Plans/REMS
  • Disciplines that interact with or support safety and pharmacovigilance functions across the product lifecycle to broaden their roles within pre-market or post-market safety and pharmacovigilance functions

Learning objectives

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

  • Identify the history, principles, and regulatory framework for benefit-risk assessments and management
  • Discuss the basic definitions of terms used in day-to-day benefit-risk work
  • Develop and maintain a benefit-risk assessment plan
  • Conduct a benefit-risk assessment
  • Select appropriate risk minimization tools
  • Describe the importance of the patient in assessing benefit-risk balance

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