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.
ASTP Annual conference is a unique opportunity to take time to exchange best practices among TT professionals and to network at an EU level.
Cécile Cavalade
ULB TTO, Belgium
One very long and hard day, but very useful for my work in TTO.
Petr Kubečka
Palacký University Olomouc, Czech Republic
Great networking, new knowledge and inspiration!
Jonas Rimbäck
University of Gothenburg, Sweden
Great atmosphere to learn and to share experiences.
Maria Ruiz Novales
Interface-Enterprises - University of Liege, Belgium
Just perfect 3 days full of information and perfect communication.
Petr Kubečka
Palacký University Olomouc, Czech Republic
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