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Events listed on BioOhio's Events Calendar are subject to change by the Event Organizer. Visit the organizer's website for current details.

13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference

May 10 - May 12

Presented by AdvaMed, the 13th Annual FDA/AdvaMed Medical Device Statistics Issues Conference will be held on May 10-12, 2021.

This annual conference brings together leading authorities from FDA, industry, and academia to address the latest statistical trends and issues facing medtech organizations. In an effort to provide quality programming in the safest and most effective manner possible, the conference will be held virtually this year. The deadline to indicate your intent to submit a poster for the annual poster session is Monday, March 15.

Keynote speaker:  William H. Maisel, MD, MPH. Dr. Maisel is Chief Medical Officer and Director of the Office of Product Evaluation and Quality at FDA’s Center for Devices and Radiological Health. He is responsible for providing leadership in the development, implementation, execution, management and direction of the Center’s broad national and international premarket, postmarket, compliance and quality programs.

Topics will include:
• Global Harmonization
• Leveraging Real-World Data and Historical Data
• Long-Term Safety Assessment
• Two-Phase Study Design
• Clinical Outcome Assessment
• Artificial Intelligence/Machine Learning in Digital Health
• Emerging Intended Uses for Diagnostic Devices
• Analytical Study Issues

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OH United States




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