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.
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
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
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 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
There was ample opportunity to learn from colleagues through the workshop sessions or more formally through speakers either sharing their years of experience or their state of the art research. Well worth attending.
John Gleeson
University of Limerick, Ireland
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