Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and a drug/biologic such that both are combined together and are required to achieve the intended result. The FDA’s Final Rule concerning combination products has been recently published and defines the regulations that apply to the various combinations of combination products. Navigating this rule and the regulations of our global neighbors is a challenge for manufacturers.
This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.
Areas to be Covered:
Combination Products Overview
Combination Products and US Regulations
Combination Product Approval Process
GMPs for Combination Products
Who will Benefit:
Drug Development Professionals
Medical Device and Diagnostics Professionals
Business development executives involved in combination product strategic partnerships
Research & Development
Product Testing Professionals
Combination product supply chain professionals
Anyone involved in the design, development, or distribution of combination products