BioMedical SIG #8

Join us for the final webinar in the BioMedical SIG series: The Regulatory Path from Academic Drug Discovery to Market Authorisation Application.

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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.

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Recent studies on both sides of the Atlantic, directed by either ASTP or AUTM, demonstrate the tremendous economic and societal benefit and value technology transfer has brought us.

Koenraad Debackere

KU Leuven, Belgium