Clinical Trials · 22. March 2024
This blog post examines key takeaways from the February 2024 CTAG meeting for Regulatory Affairs and Study Start-Up professionals. The focus is on proposed changes to streamline applications for substantial modifications and adding new EU member states to trials. Additionally, the post explores resources to aid sponsors transitioning from the Clinical Trials Directive to the CTR.
Clinical Trials · 21. March 2024
European clinical trials have their own set of regulations. The Clinical Trial Coordination and Advisory Group (CTAG) plays a key role in shaping these regulations. This post explores CTAG's function and its impact on clinical trials in Europe.
Clinical Trials · 05. March 2024
The updated recommendations endorsed by the CTAG in March 2024 provide comprehensive guidance for stakeholders navigating the utilization of Auxiliary Medicinal Products (AxMPs) in clinical trials, ensuring adherence to evolving regulatory standards, particularly the Clinical Trials Regulation (CTR EU 536/2014).
