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
On the occasion of our 25th anniversary we have set-up a series of hybrid workshops – with virtual participation for those who do not have a chance to celebrate with us in person.
The registration is now open for the first one taking place on October 11th, 2023 in Frankfurt and dealing with exciting topics reflecting the international discussions of harmonisation with focus on some burning open issues – and we will show future approaches that have a chance to contribute to international modern trends.
Curious? Click here, get a picture for yourself of the exciting topics we have selected for you and do not forget to sign in.
The team of speakers has been confirmed and we are pleased to welcome
- Henning Blume
Frankfurt Foundation Quality of Medicines
Germany - Helmut Schütz
BEBAC Consultancy Services for Bioequivalence & Bioavailability
Austria - Barbara Schug
SocraTec R&D GmbH
Germany - Paulo Paixao
Infarmed
Portugal - Robin Michelet
qPharmetra / Freie Universität Berlin
Germany - Anders Fuglsang
Fuglsang Pharma
Denmark
who will present exciting topics on current issues in bioequivalence studies.