CDISC – Insight, Impact and Implementation 2012

Key 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)