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.
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
I had a great experience and met high profile professionals.
Antonio Menegatti
Politecnico di Milano, Italy
Good opportunity to discuss common issues with fellow professionals and to get updates about the community.
Giuseppe Visimberga
Leiden University, Netherlands
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 learned more in the training course for 3 days than I did in the last 3 months at my job. The lectures were informative & interesting.
Hanna Sonnig
Setterwalls Advokatbyrå, Sweden
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