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.
One very long and hard day, but very useful for my work in TTO.
Petr Kubečka
Palacký University Olomouc, Czech Republic
The expert-panel discussion educated me in strategic and meritorious choice of inventions to approach investors and manage investment funds for establishing a spin off.
Ram Siddappa
Erasmus MC, Netherlands
A must-do for any staff involved in technology transfer and start-up creation.
Frederic Ratel
Institute of Chemical Research of Catalonia, Spain
Great networking and learning opportunities to share knowledge with colleagues from their various areas of expertise.
Bruno Woeran
Merinova OY - TII President, Finland
As always, superb topics and inspirational speakers. Great networking. Well worth the time out of the office!!! Great work HQ, thank you.
Peter Deakin
Chalmers University of Technology, Sweden
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