Newly emerging products which combine drugs, devices and biologics are expected to provide new opportunities in bridging device and drug capabilities; and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for combination products. A risk - based approach requires not only a strategy but also tools to define key indicators to measure specific risks. Key Risk Indicators (KRIs) and risk- based quality management (RBQM) systems should focus on safety of research subjects and data integrity.

Combination products, due to their specific nature, can increase risks while being tested in clinical trials.  Metrics critical to risks and quality management should be linked to particular processes within development program for combination products. Ongoing collaboration between regulators, industry and other stakeholders is essential to streamlining of the global combination entities development and approval process in a way that will produce safe and effective products for consumers.

Course Objectives:

A risk- based approach requires not only a strategy but tools to define key indicators to measure specific risks. As reference from the recent FDA and EMA guidance, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on “what really matters” and safety of research subjects and data integrity should be emphasized. Combination products, due to their specific nature, can increase risks while being tested in clinical trials.  These critical metrics should be linked to particular processes within development program for combination products. Current regulations and best practices for clinical trials with combination products will be discussed in this session.

Course Outline:

• Provide an overview of types of combination products
• Review current regulatory updates and guideline for combination products
• Discuss streamlined approach for combination products
• Describe principles of Quality by Design (QbD) and new regulatory requirement for Risk-based monitoring and how it applies to trials with combination products
•Develop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems
•Identify and manage risks of clinical trials with combination products
•Perform Cause-Effect Analysis for identified risks and develop mitigation strategy

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Coordinators
• Clinical Principal Investigators
• IRB Administrators and Members