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Catalyzing the Integration of Digital Technologies in Healthcare Solutions
Session Chair(s)
Falk Ehmann, MD, PHD, MS
Head of Innovation and Development Accelerator
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Increasingly medicine development utilizes digital technologies including digital therapeutics with the potential to provide transformative treatment opportunities. Challenges to the current regulatory framework need to be translated into opportunity. This session will discuss examples of complex healthcare solutions and analyze enabling factors to facilitate their progress from early proof of principle to market access.
Learning Objective : Describe how digital (therapeutic) technologies are transforming drug development and their regulation; Identify opportunities on how to catalyze for more integrative approaches in the development and regulation of medicines and digital (therapeutic) technologies; Discuss scientific and regulatory opportunities how to enable the integration of digital (therapeutic) technology in medicines development.
Speaker(s)
Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support Offered by FDA
Bakul Patel, MBA, MS
Google, United States
Sr. Director, Global Digital Health Strategy and Regulatory
Floodlight Development: A Case Study
Seya Colloud, PHARMD
F. Hoffmann-La Roche Ltd, Switzerland
Global Regulatory Director
Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support by EMA
Armin Ritzhaupt, PHD, MPH
European Medicines Agency, Netherlands
Scientific Administrator