Inspection Case Synapse Lab

The inspection case “Synapse Lab”, where the EMA has published a corresponding inspection report, gives our workshop additional topicality. A critical inspection finding – in addition to the question of “data integrity” – points in the direction of “overlapping profiles / profile duplication”. What this means and how to detect it in bioequivalence trials will be illustrated by our speaker Anders Fuglsang, who has been involved in the processing of comparable cases in the past and is also actively contributing to the Synapse case with his specially developed software.

Our exciting and “red-hot” bioequivalence workshop takes place on October 11th, 2023 on the occasion of our 25th anniversary. Planned as a hybrid event, you can participate on site at the Frankfurt Airport Club or online.

The topics?

• Multi-group and multi-center – effects in BE trials
• Endogenous substances and the heterogeneity of physiological baselines
• Narrow Therapeutic Index Drugs
• PopPK modelling and simulation support generic development
• Manipulation of BE trial outcomes: A potential serious risk to public health

Curious? We have invited experienced specialists to put together an exciting and forward-looking workshop. Do not forget to sign in.

The teams of SocraMetrics and SocraTec R&D