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.
Starting or changing any procedure at a TTO/Institution is challenging and I could not think of anything better than learning with the best.
Ricardo Castro
Centre for research in agricultural Genomics, Spain
A lot of fruitful discussions with experienced peers. Very helpful sessions.
Sara Matt-Leubner
University of Innsbruck, Austria
The course Software Specific Challenges is a must for every TTO/KTO professional, especially for those working with Social Sciences and Humanities!
Brechtje Vreenegoor
Radboud University, Netherlands
ASTP Annual conference is a unique opportunity to take time to exchange best practices among TT professionals and to network at an EU level.
Cécile Cavalade
ULB TTO, Belgium
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
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