• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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The Cross-Border Applicability of RWD in Decision-Making

Monday, June 03, 2024
Breakout Session
Regulatory Innovation
31C
Through the myriad of health data creation globally, there has been a growing interest in utilizing real-world data (RWD) and real-world evidence (RWE) for regulatory and health technology assessment (HTA) decisions. However, identifying high-quality RWD sources is challenging, leading to the consideration of transferring RWD from different regions. While some theoretical guidance exists, a more comprehensive undertaking is necessary. This panel will discuss how industry, data vendors, legislators, and regulators can collaborate to open high-quality data sources, reduce methodological issues, and enable RWD through harmonization for cross-border data accessibility. It will also present unique perspectives from different regions, including the US, Asia, and Europe.
Moderator
Rachel Ehlers, JD
Partner
Baker McKenzie
Speakers
Michele Colucci
Founder & Managing Partner
DigitalDx Ventures
Michelle Wong, JD, MBA
Head of Operations
Octant
Jonathan Fairtlough
Principal, Advisory, Cyber Security Services
KPMG US
Virginia Sanzone
General Counsel
ICU Medical
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