• 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

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
  

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