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SCDM 2025 Annual Conference

Pre-Conference Workshops

Take your CDM skills to the next level.

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Discover the #SCDM25 workshops

September 27, 2025
The SCDM25 pre-conference day is filled with engaging and interactive Pre-Conference Workshops, designed to take your CDM skills to the next level. Delivered by industry experts, these sessions are specifically crafted to provide practical, actionable strategies you can implement in your day-to-day job.
Register here
The SCDM25 pre-conference day is filled with engaging and interactive Pre-Conference Workshops, designed to take your CDM skills to the next level. Delivered by industry experts, these sessions are specifically crafted to provide practical, actionable strategies you can implement in your day-to-day job.

Dawn Kaminski, eClinical Solutions & Dan Crawford, Veeva Systems

Data Requirements for an FDA Submission

1:30 PM to 6:00 PM

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.