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.
I am happy to be able to share my own experiences with other colleagues via various courses, and I enjoy every moment I can spend in this network. Proud to be part of the ASTP community!
Paul van Dun
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
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
The expert-panel discussion educated me in strategic and meritorious choice of inventions to approach investors and manage investment funds for establishing a spin off.
Ram Siddappa
Erasmus MC, Netherlands
Thank you for such enjoyable inspiring event, great choice of the lecturers!!!
Linda Ondrackova
University of Pardubice, Czech Republic
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