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CDISC - FDA’s Expectations, Requirements For US FDA Submissions, Concepts And Implementation; 2013 & Beyond
Friday, January 25, 2013 from 10:00 AM to 1:00 PM (PST)
Palo Alto, CA
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.
Areas covered in this 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.
- Brief overview of the basis for FDA’s authority to require CDISC.
- Timelines for CDISC requirements among different market segments (Drugs, Devices, etc.)
- What “compliance” means.
- Overview of CDISC and what submission data are covered.
- What parts of CDISC will be required.
- Opportunities to influence what “compliance” means.
- Resources for understanding the standards.
- Benefits of standards to FDA, sponsors & CROs.
- Functional areas that will be impacted.
- Resources to assist with implementation.
- 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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.