Combination Products GMP and Regulatory Overview (1.5 hours)

This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment.

Key learning objectives:

• Define combination products
• Describe the United States and European Union regulatory framework applicable to combination products
• Define the primary mode of action of a combination product, and
• Describe evolving regulations in the EU and their impact on combination products.

This course is designed for people new to the combination products industry and those interested in understanding the fundamentals of combination products regulation.

This course provides an overview of the US and EU regulatory framework relative to combination products.