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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 11 Track 4: New Trends and Challenges in Combination Products, Companion Diagnostics, and Digital Health Technologies

Session Chair(s)

Vahe  Ghahraman, PhD

Vahe Ghahraman, PhD

Senior Director, Global Regulatory Operations Head

Apellis Pharmaceuticals, Inc. , United States

This session focuses on challenges and opportunities related to the development and commercialization of combination products and companion diagnostics from both the regulatory and industry perspectives. It also covers the impact of the recent advancements in digital health technologies for improving healthcare outcomes and patient experiences. Furthermore, it offers considerations and ways to manage the complex challenges created by myriad of new regulatory policies and ensure compliance with safe and efficacious deployment of such technologies.

Learning Objective :
  • Evaluate impacts of combination products on regulatory affairs' ways of working
  • Share challenges in dealing with Health Authority regulatory processes and pathways related to development and commercialization of combination products and best practices to manage them
  • Explore the considerations and challenges associated with operationalizing regulatory policy assessments for digital health


Kavita A. Vyas

The Growing Impact of Combination Products and Companion Diagnostics – A Regulatory Perspective

Kavita A. Vyas

FDA, United States

Review Chemist, OD, CBER

Brian  Williams

The Growing Impact of Combination Products and Companion Diagnostics – An Industry Perspective

Brian Williams

KPMG, United States

Advisory Managing Director, Life Sciences

Stephen  Philipp

Considerations and Challenges of Operationalizing Regulatory Policy Assessments for Digital Health

Stephen Philipp

Merck, United States

Associate Director Regulatory Digital Health / Policy Execution

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