Module 12 Presentations

26/01/2024

Target audience and applications: CDISC Benefits for Regulators

Center for Drug Evaluation and Research (CDER) – INDs and NDAs

Center for Biologics Evaluation and Research (CDER) – INDs* and BLAs *Commercial INDs only

Center for Devices and Radiologic Health (CDRH) – IDEs and PMAs

Center for Veterinary Medicine (CVM)

The Organisation for Professionals in Regulatory Affairs

13

CDISC Benefit for Sponsors

 Streamline the Clinical Trial process ● Infrastructure ● Science of design and analysis ● Conduct

Create clinical data standards throughout spectrum :

Collection ODM/CDASH

Exchange ODM

Submission SDTM and ADaM

 Utilization of Review Tools (similar to FDA eReview)

The Organisation for Professionals in Regulatory Affairs .

14

7