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EU Addresses Concerns Over Switching Multinational Studies To Clinical Trials Regulation

 
• By Vibha Sharma

EU regulators are to speed up their evaluation of applications to transition ongoing multinational studies to the CTR.

Business, Technology, Internet and network concept. Business man working on the tablet of the future, select on the virtual display: Clinical trial
Sponsors must consider several factors before transitioning ongoing studies to the Clinical Trials Regulation • Source: Shutterstock/ Den Rise

With approximately 18 months remaining for studies authorized under the erstwhile EU Clinical Trials Directive (CTD) to switch to the Clinical Trials Regulation (CTR), member states have agreed on a new expedited, one-week evaluation procedure to support the transition of multinational clinical trials meeting certain requirements.

The expedited procedure is explained in a “best practice guide” drawn up by the Clinical Trials Coordination Group (CTCG),...

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