Topics
- What documents FDA can enforce?
- Brief overview of the types of regulatory documents impacting FDA
- Overview of CDISC
- The combination of specific documents giving FDA authority to require CDISC
- What standards exist now and what is in development?
- What data are included in CDISC`s standards?
- When the standards will be required and for whom?
- The impact on drug, biologic, device, generic and biosimilar sponsors and CROs
Who should Attend
Data warehouse designers and developers, Regulatory Affairs, Biostatisticians, Clinical and pre-clinical research, Clinical and pre-clinical data managers, Documentation, Statistical programmers, Database programmers, Safety surveillance systems managers and EDC systems managers.
(CDISC - Clinical Data Interchange Standards Consortium)
