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
This course offers an opportunity to meet likeminded people, share tips and tricks, and dive into different approaches to help you set up and improve KTO processes.
Brechtje Vreenegoor
Radboud University, Netherlands
Excellent professional gathering, perfect collection of topics and very up-to-date insight.
Ludovic Urgeghe
University of Mons, Belgium
Three days of learning and networking in Dublin at ASTP annual conference. What a great event!!
Sandra Aresta
CIBIO - Centro de Investigação em Biodiversidade e Recursos Genéticos, Portugal
Working and Learning with old and new friends – best way to do it!
Sara Matt-Leubner
University of Innsbruck, Austria
Join our newsletter and get the latest news