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 has attained a unique position that has turned it into a highly valued player on the global technology transfer scene.
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
Technology transfer is ever changing and a key piece for the competitiveness of your institution, this course is an excellent tool to prepare yourself for that challenge.
Ricardo Castro
Centre for research in agricultural Genomics, Spain
Great networking, new knowledge and inspiration!
Jonas Rimbäck
University of Gothenburg, Sweden
The new website signals this pioneering, resonating role and is a tribute to the many accomplishments and innovations European TTO’s have generated and implemented over many years, thus strengthening both our economy and society.
Koenraad Debackere
KU Leuven, Belgium
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