Safety Assurance Cases for Combination Products

This 2-day course provides attendees with an understanding of safety assurance cases and how they can be applied to combination products to demonstrate safety and facilitate pre-market review communications with the FDA. It covers the elements of assurance cases; the common issues and resolutions related to assurance cases; and the structure templates and approach for using assurance cases to achieve three important goals: to demonstrate safety, to create and review a safety assurance case with good arguments and evidence, and to relate the results to managing risk and improving product safety.

There will be examples and interactive exercises to reinforce learning and allow participants to apply their new knowledge to create and review safety assurance cases and hear feedback from the FDA reviewers. The program also offers the opportunity for the participants to interact with FDA reviewers on questions related to safety assurance cases.

Agenda

• A. Course Introduction
• B. Risk Management and Safety
• C. Assurance Case Method
• D. Safety Assurance Case Argument Structure
• E. Develop Argument on Risk Mitigation Adequacy
• F. Develop Safety Argument on Verification & Validation Adequacy
• G. Develop Safety Argument on Reliability Adequacy
• H. Develop Confidence Argument on Safety Case Effectiveness
• I. Combination Product Industry Practices of Assurance Cases – Case Study
• J. Assurance Cases, Risk Management, Safety and Regulatory Science

Who Should Attend

• Regulatory Affair Professionals
• Safety/Risk Management Engineers
• System and R&D Engineers
• Quality Assurance
• Management (Managers, Directors, or Senior Management)
• Industry Consultants
• 3rd Party Reviewers
• Patient Safety Advocators
• Any professionals who are interested to learn about safety assurance case method and its applications to combination products or medical devices.

Prerequisites

No previous experience with safety assurance cases is required. A basic understanding of medical device risk management concepts and terminology would be a plus.