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2023-02-16: The EU Clinical Trials Regulation implementation
North Carolina Biotechnology Center_Hamner Conference Center
15 T.W. Alexander Drive
Research Triangle Park, NC 27709
United States

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Thursday, February 16, 2023, 5:30 PM - 8:00 PM EDT
Category: Events

Update: The EU Clinical Trials Regulation implementation

Speaker: Kirsten Messmer, PhD, RAC
Senior Research Analyst , AgencyIQ

This event is In-person
The in-person portion will have food and drink and will take place at the at IQVIA's Innovation Park location;
Innovation Park, 2400 Ellis Road, Durham, NC, 27703. .

The Clinical Trial Regulation came into application in Europe on January 31, 2022. More importantly since January 31, 2023, ALL NEW clinical trials need to be submitted through the new Clinical Trials Information System.
This regulation harmonizes clinical trial applications throughout Europe and aims to create a favorable research environment for medicinal product development. The Clinical Trial Directive which is still applicable for already ongoing trials until January 2025, created a patchwork of national clinical trial requirements. Although national requirements still apply, the Clinical Trial Regulation simplifies the application process by providing a one-stop E.U. portal, the Clinical Trial Information System (CTIS), for clinical trial submissions and management. This allows for a single clinical trial application submission to all targeted E.U. and E.A.A. countries.
The presentation will discuss the clinical trial landscape in Europe. We’ll also address some questions around the implementation and update such as: How has the Clinical Trial Regulation application and CTIS use worked out over the last year? Did the system work as advertised and tested? Were there glitches in the use of the system? What impact did the new implementation deadline have? 



Contact: [email protected]