27 April 2023, Frankfurt

For the first time we developed the agenda to combine topics that are relevant for both Clinical Operations and Clinical Trial Supplies. Dr. med. Johanna Schenk, who successfully established and continued to develop the expert talks series handed over the moderation and organization of future event to Sascha Sonnenberg, the new Managing Director of SanaClis DE.

In turn, Johanna Schenk was recognized for her ongoing contribution to developing the Expertengespräch into a highly valued event in clinical trials.

Event Summary

As the first speaker Prof. Dr. med. Sebastian Harder spoke about the new EU-CTR 536/2014. He presented changes and what has to be considered by submitting sponsors. A finding he shared was that the overall quality of language/grammar used in new submissions is decreasing.
Dr. med. Matthias Klüglich allowed us a view of the new EU-CTR 536/2014 from a sponsor perspective. He presented his experience with the CTIS (portal and database), timelines and obligations. He also spoke about how to deal sensitive information and shared lessons learnt about CTIS functionality.
Direct-to-Patient services are an important element of Decentralized Clinical Trials . Dr. Andrea Zobel took us on a journey through the jungle of laws and regulations. She compared the different ways clinical trial materials can be distributed to the patient and the disagreements and discrepancies in applicable laws and regulations across different countries.
Dr. Alexander Debets delighted us with examples of innovative technologies such as eLabels and a shoe that can collect and provide patient information. He explained to the audience that even if these innovations are new to us some of them are already well established in other industries or have even been approved by e.g. FDA and are used for the production (3D printing) of certain medication, or to engage and interact with patients