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戻る Agenda
Session 10: Co-Development of Digitally Connected Combination Products
Session Chair(s)
Bill Zeruld
Business Development - Digital Strategy
Otsuka America Pharmaceuticals, Inc., United States
Permutations of device, drug, and digital (three D’s) are becoming the norm for large and small companies alike as applications are being integrated into existing drug-device platforms. Differentiating between different categories of digital health products (digital therapeutics, drug companion apps, etc.) is necessary to formulate the most appropriate regulatory and quality strategy for connected combination products. This session will help demystify the various permutations of “the three D's” into a cohesive regulatory approach.
Learning Objective : - Identify similarities and differences in developing and regulating drug companion apps, digital monotherapies, connected drug delivery devices, and other combinations of the three Ds
- Describe key clinical study design considerations for connected combos including unique endpoints, instrumenting for real world data collection, and more
- Summarize practical considerations in quality, supply chain, and infrastructure needed to support connected combination products
Speaker(s)
Co-Development of Digitally Connected Combination Products
Lori-Ann Archer
Independant Consultant, United States
Medical Device and Combination Products QMS Expert