14 April 2016
Emergo Group Headquarters
The RAPS Texas Chapter invites you to join us for an opportunity to meet local colleagues and learn more about preparing for a Medical Device Advisory Panel Meeting.
FDA recently released a Draft Guidance entitled Procedures for Meetings of the Medical Devices Advisory Committee. While this is a welcome update to the previous guidance from 2000, there are some significant proposed procedural clarifications and modifications that will have broad impact on Sponsors, at all stages of the IDE and PMA processes. Sponsors need to understand these changes and their implications so they can anticipate likely panel questions well before PMA submission and proactively engage with FDA early and consistently throughout the device development program.
This presentation will walk you through key aspects of the guidance and provide practical strategies for gaining a positive panel vote within FDA’s revised framework. You’ll learn to:
- Understand the process leading up to a panel meeting, for both the Sponsor and FDA
- Identify key project activities that can be strengthened by incorporation of panel considerations, during both the IDE and PMA
- Strategize opportunities for improving the chances of success for your panel-track project
Free parking is available onsite and light refreshments will be provided for all attendees. Those who hold the RAC may claim 1.5 RAC recertification credits.
Thursday, 14 April 2016
6:00–6:30 pm Registration, Networking and Refreshments
6:30–8:00 pm Speaker Presentations and Q/A Session
Emergo Group Headquarters
816 Congress Avenue
Third Floor, Longhorn Room
Austin, TX 78701
Get directions online or call +1 512 327 9997
Advance Registration (prior to 8 April):
RAPS members: $30 Nonmembers: $45
Registration (on or after 8 April):
RAPS members: $40 Nonmembers: $55
Chris Miller, biostatistician, communications strategist, medical writer, 3D Communications, LLC
Chris Miller is a biostatistician who brings experience in the design, analysis, and interpretation of clinical trials to 3D clients. As a senior project manager, 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.
Trilo Das, RAPS Texas chapter chair
Wesley Carr, senior manager, chapter and account relations, RAPS