CDISC - FDA’s Expectations, Requirements For US FDA Submissions, Concepts And Implementation January 25, 2013

This 3-hr training on CDISC standards will explain why FDA can require that all clinical and some pre-clinical data in most regulatory submissions use CDISC standards. It will discuss who will be affected and when by these requirements, what being compliant means and what resources can help.

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. 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 3-hr session 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.

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702687?channel=yahooevent