Are You Ready for the Changes Coming with NPRM and the EU Portal?
Date: February 25th, 2016
Time: 11:00 am EDT
Location: Your desktop
The NPRM in the US and the European Clinical Trial Regulation in the EU promise to put additional time pressures on clinical trial disclosure teams. Is your team ready to meet these emerging requirements?
The time to prepare is NOW.
The new regulations will:
- Mandate significantly reduced reporting timelines (some timelines reduced by as much as 50% in the US and 83% in the EU)
- Demand operational efficiencies and formalization of interdepartmental coordination at new, broader levels
- Require changes to existing procedures and SOPs documentation
These evolving requirements are moving clinical trial sponsors to improve responsiveness, address data governance issues and review data sources and processes, all while maintaining data integrity and compliance.
Please join Thomas Wicks, Chief Strategy Officer and Matt DeFranco, Senior Product Specialist, as they identify practical approaches for disclosure teams to start preparing now for NPRM and the EU Clinical Trial Regulation.