How to Avoid Significant Delays in Multi-Country Studies Due to EU 536/2014 Clinical Trial Regulation, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will discuss why the new EU 536/2014 clinical trial regulation will require coordinated, detailed global and EMEA planning and management. Attendees will learn about the most critical business roles to ensure study success with EU 536/2014 clinical trial regulation, which study activities and content are most likely to be on the critical path for EU submissions, how to use machine learning for accurate submission prediction and how to ensure ongoing progress to identify critical process bottlenecks.
TORONTO, Ontario, Jan. 11, 2022 /PRNewswire-PRWeb/ -- Until now, most tasks required to start enrolling patients could largely be planned and managed independently, with minimal coordination between study, country and site project managers. This has allowed decentralized, unsophisticated planning and management, with only oversight responsibilities for global and EMEA project managers.
As of January 2023, EU 536/2014 requires all new studies to be submitted under the Clinical Trial Regulation and to use the Clinical Trials Information System (CTIS) for submissions — which means that all countries and sites needed for large multi-country studies must be identified prior to July 2022. Project planning and management roles and systems must be implemented, or large multi-country studies run a significant risk of incurring months of delay.
Join this webinar to learn:
- Why EU 536/2014 will require coordinated, detailed global and EMEA planning and management
- What the most critical business roles are to ensure study success with EU 536/2014 Clinical Trial Regulation
- Which study activities and content are most likely to be on the critical path for EU submissions
- How to use machine learning for accurate submission prediction
- How to ensure ongoing progress to identify critical process bottlenecks
Join Pierre Omnes, Executive Director, SSU and Regulatory, Syneos Health; Marieke Meulemans, CEO & Founder, GCP Central B.V.; Paulien Nuyts, Junior Manager Regulatory Risk LS&HC, Deloitte; Leona Fitzgerald, Executive Director Regulatory Affairs, PPD, ACRO committee member; Sylvia Marecki, Director, Operational Design Lead, Operational Designs & Strategy, EMD Serono, Inc; and Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences, for the live webinar on Thursday, January 27, 2022 at 10am EST (3pm GMT/UK).
For more information, or to register for this event, visit How to Avoid Significant Delays in Multi-Country Studies Due to EU 536/2014 Clinical Trial Regulation.
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