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
This course gives an in-depth understanding on managing contract portfolio, including research contracts, license agreements, and other collaboration agreements.
Ram Siddappa
Erasmus MC, Netherlands
Excellent organisation, multifarious activities, great atmosphere… I can't say enough about how well it is tailored to the needs of technology transfer professions.
Tamara Čolić Milosavljević
Centre of Technology Transfer - University of Belgrade, Serbia
Three days of learning and networking in Dublin at ASTP annual conference. What a great event!!
Sandra Aresta
CIBIO - Centro de Investigação em Biodiversidade e Recursos Genéticos, Portugal
ASTP has excellent courses to immerse yourself into the world of tech transfer.
Qing Cai
Vrije Universiteit Brussel, Belgium
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