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

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