CDISC – Insight, Impact and Implementation

Why Should You Attend:

As part of the recent FDA Safety and Innovation Act of 2012 (FDASIA), the FDA acquired the authority to require that clinical data in drug, biologic, device, generic and biosimilar submissions utilize CDISC standards. This authority comes from a combination of 5 different regulatory documents, each of which provides some information about the requirements. Because changing what clinical data are collected and how they are collected is a long process, sponsors and CROs need to start planning now.

This webinar will explain where the FDA’s authority comes from, what CDISC is, who will be affected and when. While CDISC itself will have a more immediate impact on technical colleagues, those responsible for planning product development programs and for project management will be affected as well.

All individuals involved in strategic or tactical planning and/or implementation of clinical and pre-clinical data design, acquisition, storage, reporting, analysis and submission should attend.

Areas Covered in the Seminar:

• Brief overview of the types of regulatory documents impacting FDA.
• What documents FDA can enforce?
• The combination of specific documents giving FDA authority to require CDISC.
• Overview of CDISC.
• What data are included in CDISC's standards?
• What standards exist now and what is in development?
• The impact on drug, biologic, device, generic and biosimilar sponsors and CROs.
• When the standards will be required and for whom?