Non-commercial clinical research often addresses issues arising from treatment practice. In this context, IITs are subject to the same regulatory framework as commercial clinical research.
At the seminar “Non-commercial clinical trials (IITs) in consideration of the new EU regulation” held by Akademie Heidelberg on 12 November 2015 in Frankfurt am Main, three of our Clinical Project Leaders discussed the impact of the new European Union Clinical Trials Regulation on the planning and handling of IITs in particular.
Various problematic issues, risks and benefits, contract design and the regulatory framework were looked into and specific suggestions for future projects were given. ClinTriCare clients will benefit from this.
The program can be found online at http://www.akademie-heidelberg.de.