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
The experts, the specific content and the informal setting will improve you as a professional.
Brechtje Vreenegoor
Radboud Universteit, Netherlands
The course exceeded my expectations. We exchanged experiences and learned different options of approaches to existing problems.
Patricia Lima
Instituto Superior Technico, Portugal
ASTP Annual conference is a unique opportunity to take time to exchange best practices among TT professionals and to network at an EU level.
Cécile Cavalade
ULB TTO, Belgium
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
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