• June 16-19, 2025
  • Boston Convention & Exhibition Center

Sessions

Loading

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
Back to Session List

BIO DOUBLE HELIX SPONSORS

Thanks to our sponsors for supporting our mission to drive a revolution to cure patients, protect our climate, and nourish humanity.

Loading

BIO HELIX SPONSORS