This annual conference, co-sponsored by FDA and AdvaMed, brings together leading authorities from FDA, industry, and academia to address statistical topics such as:

• An overview of clinical study data management
• Roles of data standards with a focus on the recently released CDISC-device domains
• ADaM analysis datasets for devices
• The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) and MDUFA III on the pre-submission process
• Recent developments in the sample size estimation and re-estimation area
• Adaptive designs with sample size re-estimation feature
• The Bayesian adaptive design CRADA software with the sample size estimation and re-estimation feature

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