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.
ASTP corroborates the strong need for profound insights and exchanges on practices, instruments and competencies that cut across functional, organisational, institutional, sectorial and geographic boundaries.
Koenraad Debackere
KU Leuven, Belgium
A must-do for any staff involved in technology transfer and start-up creation.
Frederic Ratel
Institute of Chemical Research of Catalonia, Spain
A lot of fruitful discussions with experienced peers. Very helpful sessions.
Sara Matt-Leubner
University of Innsbruck, Austria
Thank you for such enjoyable inspiring event, great choice of the lecturers!!!
Linda Ondrackova
University of Pardubice, 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
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