CDISC – Insight, Impact and Implementation
September 28, 2012 - Palo Alto CA US
This 90-minute webinar will explain why FDA requires clinical data submissions to use CDISC standards, the impact on drug, biologic, device, generic and biosimilar sponsors and CROs, and when and for whom these standards will be required. 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.