CDISC for US FDA Submissions - Are you Compliant?

Why Should You Attend:

FDA now has the authority to require CDISC standards for all clinical and some pre-clinical regulatory submissions data. As with most regulatory action, being “compliant” will look somewhat different with respect to various parts of the CDISC standards, different functional areas in a company and different market segments (drugs, devices, etc.).

Timelines for CDISC adoption vary by market segment, and some CDISC standards are not required but may be in sponsors’ best interests to adopt. This training will provide a clear understanding on what “compliant” means, so as to avoid confusion. We will also discuss and evaluate available resources for interpreting the standards and determining what must or should be adopted.

This 90-minute session will show how you can carefully plan to develop and implement these (CDISC) standards across all groups that design, handle or interpret the data. The presenter will share resources that can assist you with this process, but in order to be ready by the deadline, companies must start now.

Areas Covered in the Seminar:

• Brief overview of the basis for FDA's authority to require CDISC
• Timelines for CDISC requirements among different market segments (drugs, devices, etc.).
• What “compliance” means?
• Overview of CDISC and what submission data are covered.
• What parts of CDISC will be required?
• Opportunities to influence what “compliance” means.
• Resources for understanding the standards.
• Benefits of standards to FDA, sponsors & CROs.
• Functional areas that will be impacted.
• Resources to assist with implementation.

Who Will Benefit:

• Regulatory Affairs
• Data warehouse designers and developers
• Clinical and pre-clinical research
• Biostatisticians
• Documentation
• Clinical and pre-clinical data managers
• Database programmers
• Statistical programmers
• EDC systems managers
• Safety surveillance systems managers

Instructor Profile:

Kit Howard, the founder and owner of Kestrel Consultants, has almost 30 years of experience in the biopharmaceutical industry and is a recognized expert in clinical data standardization, data quality and data management. She provides consulting and training services in these topics for pharma, biotech, medical device, academic research and regulatory organizations. She has published extensively, presented at more than 50 conferences, and has recorded more than three dozen webinars.

Kit co-leads the CDISC Medical Devices Standards team, is a member of the CDISC CDASH (data capture) management team, a CDISC Registered Solutions Provider and an official CDISC trainer. She is a certified clinical data manager and serves on the Society for Clinical Data Management’s Editorial Board. Kit an instructor in the School of Medicine’s Program in Public Health at Michigan State University and holds a graduate degree in Clinical Research Design and Statistical Analysis from the University of Michigan.

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