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Paving a New Road for Digital Health – Global Trends in Software Regulation
Session Chair(s)
Lesley Maloney, PharmD
Global Regulatory Policy Lead - Digital Health and Integrated Solutions
Genentech, A Member of the Roche Group, United States
Current regulatory paradigms cannot accommodate the speed and agility that digital health demands, requiring regulators to reimagine their frameworks to provide users with timely access to safe, effective high quality digital health products.
Learning Objective : • Discuss the current global landscape related to software regulation. • Compare and contrast approaches the EU and other Health Authorities are using to reimagine their regulatory frameworks, including around software qualification, classification, review, and alternative pathways to market. • Identify additional policy and regulatory challenges and opportunities related to development of risk-ba
Speaker(s)
Panelist
Sarah Cowlishaw
Covington & Burling LLP, United Kingdom
Partner
Panelist
Manan Hathi
Styker, United States
Senior Manager, Regulatory Affairs
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