Given the Food and Drug Administration’s (FDA) increased scrutiny of device efficacy and long-term safety, the agency is conducting more panel meetings each year. Strong clinical data alone are no longer enough to win approval. In today’s environment, it is critical for sponsors to prepare a clear, credible and engaging presentation. You must also ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation.

Most companies are ill-equipped to prepare for this critical, yet daunting meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This webinar will provide you with proven steps that will optimize your success before an FDA Device Panel.

Upon the presentation's conclusion, you should be able to:

  • Understand all the essential steps necessary to be successful at an FDA Device
    Panel meeting
  • Create a realistic schedule / timeline
  • Staff a team of internal personnel and external advisors to properly prepare

Date: November 1, 2012
Time: 12 PM ET | 11 AM CT | 9 AM PT
Cost: $249.00

Speakers:

Susan Resnick



Susan Resnick
3D Communications

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Jim DiBiasi

Jim DiBiasi
3D Communications

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Moderator:

Norbert Sparrow

Norbert Sparrow
Editor, UBM Canon

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Sponsored by:

3D Communications

About 3D Communications: 3D Communications specializes in turnkey FDA meeting preparation – including FDA development meetings, regulatory submissions, advisory committee meetings, device panel meetings, scientific communications skills training and stakeholder engagement. We have provided strategic counsel and hands-on tactical implementation to support regulatory submissions for more than 75 projects, involving 25 different FDA committees.

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Price Per Person: $249.00


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