Second EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on Quality'

Date: 09/02/2008
Location: London
On 8 February 2008, more than 140 representatives from micro, small or medium sized enterprises (SMEs) and their stakeholders participated in this SME workshop, the second of its kind held at the EMEA. The objective of the workshop was to provide an overview of data requirements for authorisation of new chemical entities and biologicals, highlighting key success factors and practical advice from an EU assessors' perspective. Presentations also included highlights from recent scientific advice and protocol assistance, GMP compliance, 'Quality by Design' and the Regulation of Advanced Therapies.


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