On August 20, CTTI will host a public webinar featuring the Medical Device Innovation Consortium (MDIC) and their recently released Patient Centered Benefit-Risk Assessment (PCBR). CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of the PCBR framework and we are pleased to take part in this event.

The goal of MDIC’s PCBR was to establish a credible framework for defining patient preferences on the benefits and risks of new medical technologies that might be incorporated into the regulatory approval process. Board Member and Project Board Champion, Ross Jaffe will give an overview of this newly released report: “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technologies.” The webinar will also include Kathryn O’Callaghan from FDA’s Centers for Devices and Radiological Health (CDRH), who will discuss the FDA’s new draft guidance, “Patient Preference Information- Submission, Review in PMAs, HDE Applications, and DeNovo Requests, and Inclusion in Device Labeling“, issued on May 13th.

Webinar Details:

• Title: Integrating Patient Preferences into the Regulatory Review of Medical Devices
• Date/Time: August 20, 12:00-1:00 p.m. EST
• WebEx Link: Click here (Meeting Number: 738 915 200 and Meeting Password: ctti)

We encourage you to forward this invitation to colleagues involved in the clinical trials enterprise.