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15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference - 2023
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. We are pleased to invite you this year to Washington, D.C. for the 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference on May 11-12, 2023. The conference will highlight promoting clinical trial innovations and advancing regulatory statistical science for diagnostics, therapeutics and other medical devices. A forum for collaboration between industry, academia and FDA, the conference will address the important mission of educating medical device manufacturers on the recent and future developments of statistical methodology and practice in the evaluation of safe and effective products.
Conference Topics will include:
- Dialogue with the New FDA/CDRH Biostatistics Division Director
- External Evidence in the Evaluation of Medical Devices
- Methods for AI/Machine Learning as a Medical Device
- The Analytical Bridging Study or Migration Study and its Study Design, Acceptance Criteria, and Statistical Analysis
- Challenges in Validating Device Output
- Statistical Issues/Challenges in the Evaluation of Digital Pathology Devices
- Latest Standards Revisions and Guidance Documents in Analytical Studies, and the Applicability to the Newest Technology, such as Next-Generation Sequencing Test
- Complex Innovative Design in Medical Devices.
- Challenges with the Pandemic – What Now?
- Subgroup Analysis
Attending the 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference is a surefire way to learn crucial information to keep you ahead of the rapid industry changes. Watch the video below of a past session from 2022 to see what you can expect to learn during the Conference. Afterwards, use the following justification letter template to help you make the case of why you should attend the Conference.
Session One: Developments in Analytical Studies (CLSI, Other guidelines)
This session discusses CLSI guidance such as EP12 and summarize current recommended study designs for Sample Community Study/Contrived Sample Functional Characterization Study.
Do you need your supervisor’s endorsement to participate in the upcoming FDA/AdvaMed Medical Device Statistical Issues Conference? We’ve developed a request template which breaks down the reasons your participation in this event is critical to your future success. Populate the template with relevant information to explain your purpose for attending the conference.