SCDM 2025 Annual Conference
Workshop
Data Requirements for an FDA Submission
Sat, Sep 27, 2025 · 1:30–6:00 PM EDT Baltimore Convention Center
About this session
This workshop will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA, EMA). We will look at the differences between a submission to the EMA and FDA and also highlight some of the tools the FDA uses to facilitate their review and their approach to reviewing the safety and efficacy portions of a submission.
Speakers
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Veeva Systems
Speaker
