Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects
Date:
03/10/2016
Location:
European Medicines Agency, London, UK
This workshop aims to provide an overview of non-clinical data requirements for the authorisation of human medicinal products, how to address these during the medicinal product development, and detail the approaches for biological and advanced therapy medicinal products. A regulatory brief on the new PRIME scheme is also included in the programme.
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Agenda - Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects (PDF/292.34 KB)
First published: 19/05/2016
Last updated: 09/09/2016
EMA/26126/2016 -
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Presentation - Key aspects of non-clinical pharmacology and pharmacokinetics in the evaluation of safety (David R Jones) (PDF/2.4 MB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Pre-clinical requirements to support development of paediatric medicines (Janina Karres) (PDF/492.57 KB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Regulatory compliance in non-clinical development (Milton Bonelli) (PDF/493.02 KB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Approaches to the non-clinical development of advanced therapy medicinal products (Fernando Mà©ndez-Hermida) (PDF/1.72 MB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Considerations for the development of biological medicinal products (Camilla Svensson) (PDF/416.33 KB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Approaches to genotoxicity and carcinogenicity assessment (Peter Kasper) (PDF/2.24 MB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - Reproductive toxicity: An introduction to regulatory aspects on detection of toxicity to reproduction for medicinal products (Gà¼nter Waxenecker) (PDF/596.29 KB)
First published: 26/10/2016
Last updated: 26/10/2016 -
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Presentation - PRIME (Jordi Llinares and Zahra Hanaizi) (PDF/823.33 KB)
First published: 26/10/2016
Last updated: 26/10/2016