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Clinical Trial Computerised Systems and Electronic Data - Lessons Learned Implementing the New EMA Guideline, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn about the EMA guideline on computerised systems and electronic data in clinical trials that all companies now need to implement if the data will be used to support a marketing authorization in the European Union (EU). Attendees will learn about the scope of impact on electronic data and computerized systems in clinical trials. The featured speakers will discuss lessons learned, inspection readiness and more.
TORONTO, Nov. 8, 2023 The new framework of globally applicable standards for clinical trial data, effective from September 9, 2023.
All companies now need to implement the EMA guideline on computerised systems and electronic data in clinical trials if the data will be used to support a marketing authorization in the European Union (EU). Effective on September 9, 2023, the guideline sets forth consolidated requirements on the use of computerized systems, the collection and use of electronic data and introduces a new framework of standards to be upheld by sponsors, investigators and their service providers globally.
The new guideline impacts sponsors, investigators and service providers involved in running clinical trials.
The new guideline impacts sponsors, investigators and service providers involved in running clinical trials. Join this ICON webinar to gain the knowledge required to achieve compliance with the new regulatory regime, with a strong focus on data accuracy, security and operational efficiency of the trial.
Join Vesta Marciulioniene, Director, Global Regulatory Clinical Services, ICON Biotech; Cooper Brown, Senior Project Manager, DCT Solution Enablement, ICON; Berit Gorsøe Kjeldsen, Director, Project Management, ICON Biotech; and George Evgrafov, Senior Manager, Technology Quality Assurance, ICON, for the live webinar on Tuesday, November 28, 2023, at 10am EST (4pm CET/EU-Central).
For more information, or to register for this event, visit Clinical Trial Computerised Systems and Electronic Data – Lessons Learned Implementing the New EMA Guideline.
About XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Issued by Xtalks. Distributed by Business Press Room.
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