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.
The best opportunity to learn and discuss common issues and interests directly with peers.
Ian Nicoud
LURIS, Netherlands
Technology transfer is ever changing and a key piece for the competitiveness of your institution, this course is an excellent tool to prepare yourself for that challenge.
Ricardo Castro
Centre for research in agricultural Genomics, Spain
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
Was great to meet counterparts in my profession who may share my experiences, but who may also have other ideas and approaches.
Tim Moser
Netherlands Cancer Institute, Netherlands
ASTP brought the right structure and terminology to my knowledge of technology licensing.
René Widmer
ETH Transfer, Switzerland
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