Given the Food and Drug Administration’s (FDA) increased scrutiny of clinical and long-term safety, the agency is calling for more public Advisory Committee and Panel hearings each year. Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation. You must 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 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 presentation will provide you with proven steps that will optimize your success before an FDA Advisory Committee or Device Panel meeting.
Learning Objectives: Upon the presentation's conclusion, you should be able to:
- Understand all the essential steps necessary to be successful at an FDA Advisory Committee or Device Panel meeting
- Create a realistic schedule / timeline to prepare for an FDA Advisory Committee or Device Panel meeting
- Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee or Device Panel meeting
This webinar is brought to you by:
Chris Miller, MS is a biostatistician who brings experience in the design, analysis, and interpretation of clinical trials to 3D clients. Chris leverages statistical expertise with excellent communications skills to integrate complex data with key messages. He guides teams to present data effectively for regulatory submissions and FDA advisory committee meetings. Prior to joining 3D, Chris was a senior biostatistician at NAMSA, providing strategic consulting for medical device companies in the areas of study design, data analysis, regulatory submissions, and FDA negotiations. Chris has published more than a dozen manuscripts in peer-reviewed medical journals. He holds a Master’s degree in Biostatistics from the University of Minnesota.
July 18, 2018
1:00pm - 2:00pm EST
Webinar instructions will be sent within 24 hours of the webinar.