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.
It was great to experience the uncomplicated and fruitful exchange with colleagues from all over Europe, as well as the positive professional spirit of this conference.
Franck Döbrich
Universitat des Saarlandes WuT GmbH, Germany
Great atmosphere to learn and to share experiences.
Maria Ruiz Novales
Interface-Enterprises - University of Liege, Belgium
Perfect place to meet colleagues and share experiences on Technology Transfer.
Lidia Aguilera
University of Luxembourg, Luxembourg
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 software training filled in the many blanks and brought my 'fractioned' knowledge in a structured way. Very useful!
Ilse Sienaert
KU Leuven R&D, Belgium
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