Many drugs start life in academia. However, limited understanding of the drug development path and more specifically of regulatory aspects that should be considered hinder progress. This session will provide an overview of the regulatory path for medicines and how it aligns and feeds into the design of pre-clinical, non-clinical, clinical and quality (chemistry, manufacturing, control – CMC) studies that are necessary for preparing a clinical trial submission and ultimately a marketing authorization application. Critical concept will be discussed that academic researchers or early-stage entrepreneurs must be aware and which can help support progressing their drug development work, accessing funding and building partnerships.
This webinar is organised by the BioMedical SIG. Join the BioMedical SIG to stay informed.
I am happy to be able to share my own experiences with other colleagues via various courses, and I enjoy every moment I can spend in this network. Proud to be part of the ASTP community!
Paul van Dun
KU Leuven, Belgium
The software training filled in the many blanks and brought my 'fractioned' knowledge in a structured way. Very useful!
Ilse Sienaert
KU Leuven R&D, Belgium
There was ample opportunity to learn from colleagues through the workshop sessions or more formally through speakers either sharing their years of experience or their state of the art research. Well worth attending.
John Gleeson
University of Limerick, Ireland
Fruitful discussion.
Cecile Henrich-Burkhardt
Technical University of Munich, Germany
Working and Learning with old and new friends – best way to do it!
Sara Matt-Leubner
University of Innsbruck, Austria
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