This course intends to :

• Give with a brief overview of types of combination products and the final rule to define their “primary mode of action” (PMOA)
• Review of current laws, regulations and guidelines for combination products
• Description of principles of risk‑based quality and safety management for combination products
• Strategy on how to develop relevant metrics as quality and performance indicators for risk-based quality management (RBQM) pharmacovigilance systems, while developing combination products
• Framework for identifying safety signals and developing management strategy based on current regulatory requirements
• FDA’s Final Rule for postmarketing safety reporting for combination products

At the end of the course, you will :

• Know the different types of combination products and select safety monitoring strategy based on streamline approach and primary mode of action

• Identify applicable regulations and guidelines for safety management throughout lifecycle of combination products

• Develop and effectively implement postmarketing safety reporting strategy for combination products

• Develop adverse event reporting systems based on Compliance Policy for combination product postmarketing safety reporting