Assessing the Benefits and Risks of Medicines: Webinar Series - Part 1: Introduction to the Benefit-Risk - Why is Everyone Talking about Benefit-Risk?

Continuing Education credit or Certificate Program units are not available for Archived Webinars

Benefit-Risk 8-Part Webinar Series Overview

Plan now on participating in this webinar series to learn more about current approaches to Benefit-Risk (B-R) assessment, including how to:

• Develop an understanding of the current B-R assessment initiatives and requirements
• 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 B-R decisions
• Identify opportunities and challenges of implementing exploratory approaches to B-R assessment
• Identify and discuss processes and methods that may enhance B-R 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

Assessing the Benefits and Risks of Medicines: Webinar Series Learning Objectives

• Describe the current status of B-R assessment and key initiatives
• Discuss approaches to perform B-R assessment to support and inform decision making
• Identify uses for B-R assessment, such as regulatory decision-making or communication with patients

Overview Part 1:

Benefit-Risk (B-R) has gained attention globally amidst growing concerns around patient safety, transparency of medical information, and efficient use of limited budgets to reimburse new medicines. The goal of B-R is to ensure that appropriate medicines are matched to patient needs.

Part 1 will be an introduction to Benefit-Risk – how it differs from simply evaluating efficacy and safety, where it’s being used, and an illustration of how it is used.

Please monitor the website for the remaining 7 parts in this webinar series.

Professionals involved in:

• Clinical Safety/Pharmacovigilance
• Risk Management/REMS
• Pharmacoepidemiology
• Regulatory Affairs
• Legal Affairs
• Medical Affairs
• Medical product safety assessment
• Marketing
• Clinical Research
• Medical Communications
• Statistics
• Comparative Effectiveness/HTAs/Health Outcomes
• Brand Commercial Teams
  

Additionally:

• Regulators facing complex benefit-risk (B-R) decisions, as well as regulatory and drug development policy makers
• Industry scientists involved in the evaluation of the B-R assessment of products in development or marketed products
• Patient representatives and advocates who wish to have greater representation of their needs and concerns in decision making
• Those wishing to learn more about the science and application of B-R assessment

Learning Objectives Part 1:

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

• Describe the characteristics of Benefit-Risk that make it a growing field of knowledge and practice in medical and regulatory science
• Distinguish best practices of Benefit-Risk versus standard descriptions of medical treatments that do not take Benefit-Risk into consideration
• Identify key areas in which Benefit-Risk information is used and how the information is helpful