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ESC Boston 2019 Schedule Viewer

 

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CANCELED: Using Real-World Evidence (RWE) to Optimize Device Development and Commercialization

Vicki Anastasi  (Vice President and Global Head, Real World Evidence Late Phase Research & Medical Device and Diagnostics Research, Icon, plc)

James Carroll  (Vice President, Real World Evidence Strategy and Analytics, Icon, plc)

Location: 160B

Date: Thursday, May 16

Time: 3:00 pm - 4:00 pm

Track: BIOMEDevice Boston, Track B: Research & Development

Vault Recording: TBD

RWE has the potential to change how medical devices and combination products are developed and commercialized. And, the implementation of the 21st Century Cures Act in the US presents an opportunity to revamp how evidentiary requirements for regulatory decision-making can more fully exploit real-world evidence (RWE) in both pre- and post-marketing approval settings.

Topics covered include:
  • What steps should companies take to make the most of the growing pool of real-world data (RWD) available and the growing acceptance of RWE to meet important research needs?
  • Using available data to fast track user input and regulatory decision-making
  • How Real-World Evidence creates a realistic commercialization plan