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.
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
I strongly recommend the course, even if you are not going to set-up an office but you are part of the team that wants to change or improve how technology transfer is done at your institution.
Ricardo Castro
Centre for research in agricultural Genomics, Spain
Just perfect 3 days full of information and perfect communication.
Petr Kubečka
Palacký University Olomouc, Czech Republic
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
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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