(0)

Online

Benefit-Risk Assessment and Management Across the Lifecycle

Review the key benefits-risk assessment methods and how to incorporate the patient perspective.

Register

Overview

This eLearning module is designed to provide an overview of the principles and frameworks used in benefit-risk assessments, focusing on regulatory requirements and the role of patient experience in decision-making. By the end of this module, learners will gain a deeper understanding of the key concepts, tools, and methodologies essential for performing benefit-risk evaluations in various regulatory settings, including the FDA and ICH frameworks. Key terminology used in benefit-risk work and clarity on qualitative and quantitative assessment approaches will be reviewed. Additionally, the module will highlight the increasingly vital role of patient input in the benefit-risk evaluation process. Methods to integrate patient experiences and perspectives will also be explored, recognizing their importance in maintaining a balanced benefit-risk profile.

Featured topics

  • Introduction to structured benefit-risk assessment
  • FDA regulations
  • Application of regulations to submissions
  • Qualitative benefit-risk assessment
  • Quantitative benefit-risk assessment
  • The patient experience

    • Who should attend?

    This course is designed for professionals working in the following areas:

    • Drug safety and pharmacovigilance
    • Safety evaluation and reporting
    • Medical monitoring
    • Medical communication
    • Medical writing
    • 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

    Learning objectives

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

    • Identify the principles and regulatory frameworks for benefit-risk assessments and management
    • Define the basic terms used in benefit-risk work
    • Recognize regulatory requirements by FDA and ICH for benefit-risk assessment
    • Differentiate qualitative versus quantitative benefit-risk assessments
    • Recognize the importance of the patient in assessing benefit-risk balance
    • Evaluate methods to integrate patient experience in benefit-risk analysis

    Have an account?

    Register

    Be informed and stay engaged.

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