Join FDA, EMEA, Health Canada, patient representatives, industry, academics, and practicing physicians to discuss progress of benefit-risk approaches, including how to: • Develop a common understanding of evolving explorations of benefit-risk assessment by FDA, EMEA, Health Canada, PhRMA, BIO and academics, • Assess how scientific approaches applied in other fields may be employed as an aid to structured and transparent decision analysis in the field of medicinal products,

·         Discuss approaches and methods to enhance transparency and communication of benefit-risk decisions,

·         Identify opportunities and challenges of implementing exploratory approaches to benefit-risk assessment in a regulatory framework through a series of case studies, and

·         Identify and discuss processes and methods that may enhance regulatory decision making, with the ability to:

– Engage multiple perspectives;

– Quantify values;

– Evaluate the impact of uncertainty;

– Incorporate preference analysis and measurement;

– Provide greater infrastructure and consistency;

– Increase transparency.

DAY 1 THEME

Current Status of Benefit-risk among Key Stakeholders

·         Keynote Panel Session: Framing the Need for Improving Benefit-risk Assessment

·         Ongoing Initiatives to Test Structured Benefit-risk Assessments

·         Strategic Methods for Valuing Risks and Benefits

·         Case Studies of Benefit-risk Assessment

·         The Value of Models for Benefit-risk Assessment

·         Panel Discussion: Regulators, Industry, Academia, and Downstream Decision Makers

DAY 2 THEME

Approaches to Methodology for Benefit-risk Assessment

·         Processes for Reaching Group Decisions on Benefit-risk Assessments

·         Graphical and Visual Approaches to Analyzing and Communicating Benefit-risk Balance

·         Approaches to Incorporating Uncertainty in Benefit-risk Assessment

·         Interfacing Benefit-risk Assessment with Health Technology Assessment and Comparative Effectiveness for the Payer’s Perspective

·         Integrating Benefit-risk into Early Development of New Products

·         Communicating Benefit-risk to the End User – Patients

·         What are the Next Steps and Priorities for Benefit-risk Assessment in the following areas?

KEYNOTE PANEL SESSION

Framing the Need for Improving Benefit-risk Assessment

FDA, EMEA, PMDA, Health Canada, Academia and Patient Advocacy Shared Discussion

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

·         Outline how senior regulators at the FDA and EMEA see the need for benefit-risk assessment,

·         Describe the scope and nature of projects to test structured benefit-risk assessments that are ongoing at the FDA, EMEA, Health Canada and PhRMA,

·         Discuss approaches to structure or quantitative benefit-risk assessment for regulatory decision making as illustrated by case studies, and

·         Identify uses for structured or quantitative benefit-risk assessment, such as communication with patients, use in various stages of the life cycle including early development, and assisting in making the process of group decision making more consistent, transparent, and documented.

This program will benefit

·         Regulators facing complex benefit-risk decisions, as well as regulatory and drug development policy makers

·         Industry scientists involved in the evaluation of the benefit-risk assessment of products in development or marketed products

·         Patient representatives and advocates who wish to have greater representation of their needs and concerns in regulatory decision making