The FDA/CDRH is hosting a webinar tomorrow, November 12, regarding patient engagement.
We thought you would be interested in attending. Below are the details about the event.
The FDA is pleased to share that on Tuesday November 12th 2019 from 2:00 – 2:45pm ET, Mimi Nguyen from FDA’s Center for Devices and Radiological Health will be holding a Webinar to discuss the Center’s recent Draft Guidance:
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
The draft guidance touches on many aspects of patient engagement in the course of clinical investigations:
- how industry can use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors,
- benefits of engaging with patient advisors early in the medical device development process,
- which patient engagement activities are generally not considered by FDA to constitute research, and
- common questions and misconceptions about collecting and submitting patient engagement information to FDA.
Interested parties are invited to review the document and leave comments HERE.
Please feel free to share this on your website or in other communications.
Any of your members wishing to join can do so here when the meeting is about to begin:
Meeting Number (access code): 908 083 552
Meeting Password: Ff2rPsmy
Join by phone
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*Those who are unable to attend to live event will be able to access the recorded session later at their convenience. This link will be shared once it’s available.