Discover Current Approaches to Benefit-Risk Assessment
Learn how to develop an understanding of the current B-R assessment initiatives and requirements, identify opportunities and challenges of implementing exploratory approaches to B-R assessment, as well as understand the processes and methods that may enhance B-R decision making, plus much more.
Benefit-Risk Assessment: A Changing Regulatory Landscape
January 30 | 11:00 AM-12:30 PM ET
Discuss the approaches to structured benefit-risk assessment being developed, implemented, and evaluated by the FDA, EMA, CIRS and the Innovative Medicines Initiative, as well as the new legal requirements for benefit-risk assessment embedded in the EU GVP legislation.
Framing for Benefit-Risk Assessment and Communication
February 27 | 11:00 AM-12:30 PM ET
Learn the importance and critical elements of framing in benefit-risk, specifically: disease state, population of interest, value perspective and context. Plus, you will discover how these framing elements lend structure and definition to benefit-risk discussions, assessments, and interpretations.
Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk
March 20 | 11:00 AM-12:30 PM ET
Explore the various approaches and requirements for choosing the endpoints for benefit-risk when designing clinical trials and postmarketing studies. Compare pragmatic examples of these approaches for setting up and displaying results of a benefit-risk assessment.
Stated Choice Methods for Valuing Benefits and Risks
April 24 | 11:00 AM-12:30 PM ET
Get introduced to the use of stated-choice methods for eliciting Benefit-Risk trade-off preferences from key stakeholders and the use of these preferences to calculate risk tolerance.
Multi-criteria Decision Analysis to Assist the Process of Decision-making
May 22 | 11:00 AM-12:30 PM ET
Discuss multi-criteria decision analysis (MCDA) as a framework to help explore and evaluate the benefits and risks of options, e.g., drug versus placebo or comparator.
A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis
June 12 | 11:00 AM-12:30 PM ET
Discuss how outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.
Visualization and Communication of Benefit-Risk
July 24 | 11:00 AM-12:30 PM ET
Learn new methods and tools, in particular new visualization tools, to structure and communicate benefits and risks.