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Combination Products Conference

Session 7: Digital Combination Products: Real World Experiences, Lessons Learned, and Opportunities

Session Chair(s)

Chin-Wei  Soo, DrSc

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


Michael  Fahmy, MS


Michael Fahmy, MS

  • Senior Director, Global Regulatory Affairs
  • Otsuka Pharmacutical Development & Commercialization, Inc., United States
Michael  Benecky, PhD


Michael Benecky, PhD

  • Senior Director, Global Regulatory Affairs
  • UCB, United States
Michael  Koenig, MS


Michael Koenig, MS

  • Group Head – Regulatory Affairs Established Products
  • Bayer, United States
Robert  Berlin, JD, MPH


Robert Berlin, JD, MPH

  • Head, US Regulatory Policy
  • GlaxoSmithKline, United States