SUNDAY, JANUARY 27 | 1:30PM-5:00PM
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve multiple components, they are associated with new regulatory, policy, development, and review challenges. In this short course, we will discuss updates to combination product regulation and explore some emerging challenges with combination products, such as adverse event reporting and principles of human factor studies during the development of combination products.
*Short Courses are not included in the meeting registration and require a separate fee.
- Explain what comprises a combination product
- Describe components of the final rule on postmarketing safety reporting requirements for combination products (referred to as the combination product PMSR final rule) issued by FDA
- Identify different methods for signal detection and management for combination products
- List technical specifications for preparing and submitting electronic Individual Case Safety Reports (ICSRs) to incorporate the combination product PMSR final rule
- Explain principles of human factors studies during the development of combination products
- Describe different ways Industry can prepare to incorporate the combination product PMSR final rule into pharmacovigilance activities