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.
Great networking, new knowledge and inspiration!
Jonas Rimbäck
University of Gothenburg, Sweden
Organisation and speakers were great, so enthusiastic about their work and very good at transferring their knowledge.
Sarka Bartova
Research Centre Rez, Czech Republic
The best opportunity to learn and discuss common issues and interests directly with peers.
Ian Nicoud
LURIS, Netherlands
Recent studies on both sides of the Atlantic, directed by either ASTP or AUTM, demonstrate the tremendous economic and societal benefit and value technology transfer has brought us.
Koenraad Debackere
KU Leuven, Belgium
Great networking and learning opportunities to share knowledge with colleagues from their various areas of expertise.
Bruno Woeran
Merinova OY - TII President, Finland
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