CHI Offering Free Webinar on FDA Draft Guidances

The California Healthcare Institute will be hosting a free online discussion on Tuesday, October 25, 2011 that addresses the FDA’s recently released draft guidance documents:

  • Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review (Aug. 15, 2011)
  • California Healthcare InstituteDraft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices (Aug. 15, 2011)

Date: October 25, 2011 * Time: 1:00 PM EDT / 10:00 AM PDT

This program will provide an overview of these recent draft guidances, including the potential impact for medical device manufacturers and clinical trial sponsors. Key topics will include FDA’s most recent thinking on clinical trial design issues and strategies for developing clinical trials that will support product clearance or approval, as well as how to navigate FDA’s current position on benefit-risk determinations. Time will also be provided for a question and answer session, as well as an opportunity to comment on the recent guidance documents.

Click here to register:

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2 Responses to CHI Offering Free Webinar on FDA Draft Guidances

  1. Do you have a PDF or PPT presentation of for this Webinar?
    Unfortunately I only came across this on a search today, and the event is already over.

    Thanks in advance for your reply,

  2. Greetings, Glenn and thank you for your interest in CHI’s webinar. Below is a link to the content you requested. Please contact CHI if you have further questions or if you need assistance.

    My best,

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