Current Program

Investigator Initiated Trials (IITs) (1 day)

On the one hand, this training is targeted at study groups aiming to conduct an investigator initiated clinical trial. On the other hand, this seminar addresses the pharmaceutical and biotech industry that is planning to support an IIT. What to watch out for? What kind of support can be provided? How far can industry go? What needs to be considered when writing the contract between the sponsor and industry? How to comply with GCP?

EU legislation (EU Clinical Trials Directive 2001/20/EC und EU Clinical Trials Regulation 536/2014) will be analysed with a focus on IITs and the German drug law will be highlighted within that context.

Fee: 820 € (19% VAT will be added)

For more information please contact us or register for this course directly via our registration form.