11 April 2018
Sponsored by: 3DCommunications
Presenting before an FDA Advisory Committee can be one of the most important – and most stressful --milestones in a product’s development. Good data alone are no longer enough to win approval. In today’s environment, companies must prepare a clear and persuasive presentation based on the data. They must also know how to answer the committee’s challenging questions in a credible and confident way. Most companies are ill-equipped to prepare for this daunting meeting alone. This webcast will provide you with proven steps used in more than 150 advisory committee meetings, to prepare your team and optimize your success.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
- Understand 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.
Who should attend
- Regulatory professionals
- Clinical professionals
- Medical Affairs professionals
- Communications professionals
Chris Miller, MS is a biostatistician who brings experience in the design, analysis, and interpretation of clinical trials to 3D Communications’ clients. Miller 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 Communications, Miller 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. He has published more than a dozen manuscripts in peer-reviewed medical journals.