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.
This is a wonderful conference to expand the horizon of my knowledge of tech transfer and commercialisation.
Seung-Ho Lee
Deltatech-Korea, South Korea
Most experienced technology transfer crew in the Europe.
Krzysztof Maternicki
Jan Dlugosz University, Poland
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
The event had something to offer all members of the TT community from entry level to mid-career and beyond.
John Gleeson
University of Limerick, Ireland
Fruitful discussion.
Cecile Henrich-Burkhardt
Technical University of Munich, Germany
Join our newsletter and get the latest news