EFS Site Best Practices: Implementation Strategies from the Sponsor Perspective

MDICx: EFS Site Best Practices: Implementation Strategies from the Sponsor Perspective

September 20, 2019, 2 p.m. ET/ 1 p.m. CT/ 11 a.m. PT

MDIC has launched a collaborative initiative in support of the FDA’s Early Feasibility Studies (EFS) program to expedite US patient access to novel devices and therapies of significant health importance. This EFS Initiative aims to remove barriers for efficiently conducting EFS in the United States by creating a network of sites and sponsors committed to using available EFS tools, meeting performance goals, and creating a learning environment where best practices are shared.

To support this effort, a representative from CDRH will provide an overview and update of CDRH’s EFS program followed by representatives from a large and a small company who will share their experience implementing EFS.

Speakers:

  • Maureen L. Dreher, PhD | Acting Assistant Director, Policy & Operations Team | DCEA1: Division of Clinical Science & Quality | OCEA: Office of Clinical Evidence & Analysis | Office of Product Evaluation & Quality | CDRH | FDA
  • Chris Cain | VP, Clinical & Regulatory Affairs | Conformal Medical, Inc.
  • Representative from Edwards Lifesciences

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