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.
Excellent professional gathering, perfect collection of topics and very up-to-date insight.
Ludovic Urgeghe
University of Mons, Belgium
ASTP has attained a unique position that has turned it into a highly valued player on the global technology transfer scene.
Koenraad Debackere
KU Leuven, Belgium
Starting or changing any procedure at a TTO/Institution is challenging and I could not think of anything better than learning with the best.
Ricardo Castro
Centre for research in agricultural Genomics, Spain
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
Great networking, new knowledge and inspiration!
Jonas Rimbäck
University of Gothenburg, Sweden
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