Third EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on Non-clinical Aspects'

Date: 02/02/2009
Location: London
On 2 February 2009, despite snow and adverse weather conditions in London, more than 100 representatives from micro, small or medium sized enterprises (SMEs) and their stakeholders participated in this SME workshop. The objective of the workshop was to provide an overview of non-clinical data requirements for authorisation of new medicinal products, highlighting key success factors and practical advice from an EU assessors' perspective. Topics covered included: safety pharmacology, requirements for first-in-human clinical trials, genotoxicity, reprotoxicity and carcinogenicity.


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