Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 EDT
Session Length: 1 hour
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of a combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.
Learning Objectives
- Analyze latest regulatory expectations and challenges
- Understand potential future innovation platforms
- Acknowledge potential and future Global Convergence/Harmonization initiatives for combination products
