The EU’s New Clinical Trial System Is Just Two Weeks Away: Are You Ready?
When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.
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UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.
Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms.
A new implementing regulation provides a legal basis for EU member states to cooperate on the assessment of trial-related safety reports linked to an active substance instead of the investigational medicinal product.