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Session 7: Digital Combination Products: Real World Experiences, Lessons Learned, and Opportunities
Session Chair(s)
Chin-Wei Soo, DrSc
Global Regulatory Head, PTR Devices and Combination Products
Genentech, A Member of the Roche Group, United States
Digital health technologies are becoming a significant element of combination product manufacturer’s product pipeline and portfolio. Navigating the FDA CDER-lead combination product regulatory landscape is challenging. This interactive session will provide (a) real world experiences from industry leading regulatory experts in securing regulatory clearances/approvals of digital combination products, and (b) interactive panel discussions involving industry and FDA representatives on topics such as regulatory pathway, prescription drug use related software framework, and lifecycle management.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe current FDA regulatory thinking and related guidance associated with digital combination products and concepts related
- Explain digital combination product regulatory challenges, opportunities, and best practices
- Apply the knowledge gained in securing approval of digital combination products
Speaker(s)
Speaker
Michael Fahmy, MS
Otsuka Pharmacutical Development & Commercialization, Inc., United States
Senior Director, Global Regulatory Affairs
Speaker
Michael Benecky, PhD
UCB, United States
Senior Director, Global Regulatory Affairs
Speaker
Michael Koenig, MS
Bayer, United States
Group Head – Regulatory Affairs Established Products
Panelist
Rob Berlin, JD, MPH
GlaxoSmithKline, United States
Head, US Regulatory Policy
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