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.
It was great to experience the uncomplicated and fruitful exchange with colleagues from all over Europe, as well as the positive professional spirit of this conference.
Franck Döbrich
Universitat des Saarlandes WuT GmbH, Germany
The new website signals this pioneering, resonating role and is a tribute to the many accomplishments and innovations European TTO’s have generated and implemented over many years, thus strengthening both our economy and society.
Koenraad Debackere
KU Leuven, Belgium
This is a wonderful conference to expand the horizon of my knowledge of tech transfer and commercialisation.
Seung-Ho Lee
Deltatech-Korea, South Korea
Exciting training, even after almost 10 hours I am curious about more experience and knowledge.
Petr Suchomel
Palacký University Olomouc, Czech Republic
ASTP's conference helped us to network with decision-makers in the technology transfer industry and provides a great platform to discuss future innovation in this sector.
Christopher Römer
Inventtory, Germany
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