CHMP Oral Explanations & FDA Advisory Committee Meetings – Understanding Similarities & Differences

When:  Oct 15, 2019 from 4:00 PM to 7:00 PM (GB)

Join us as we hear from Kate Dion from 3D Communications on the topic "CHMP Oral Explanations & FDA Advisory Committee Meetings – Understanding Similarities & Differences to Optimize Preparation", in which she provides us with practical information we can use to be more effective in our preparation for CHMP Oral Explanations & FDA Advisory Committee Meetings. Learn how to use the information to help set realistic timelines, choose the best core presenters and team members, plan and conduct effective mock meetings, utilize-technologies to improve the preparation, and maximize the Open Public Hearing.

You will also learn how to:

  • Determine what deliverables will be needed for an FDA Advisory Committee / Panelmeeting and a SAG / CHMP Oral Explanation
  • Appropriate Prepare and maximize the team’s time for an FDA Advisory Committee /Panel meeting and for a SAG / CHMP Oral Explanation
  • Construct appropriate timelines for an FDA Advisory Committee / Panel meeting anda SAG / CHMP Oral Explanation
  • Choose the appropriate team members, including external experts for an FDA AdvisoryCommittee / Panel meeting and a SAG / CHMP Oral Explanation

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