Fifth EMA workshop for SMEs "Regulatory considerations in initiating clinical trials"

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TitleFifth EMA workshop for SMEs "Regulatory considerations in initiating clinical trials"
Date28/05/2010 - 28/05/2010
LocationLondon, UK
SummaryOn 28 May 2010, more than 150 representatives from SMEs and their stakeholders participated in this SME workshop. This workshop was prepared in cooperation with the Clinical Trials Facilitation Group (CTFG). Regulators and SME representatives made presentations and participated in the discussion panels. Topics included an overview of the clinical trial authorisation framework in the EU, information on data requirements for initiating clinical trials, authorities’ perspectives and regulatory requirements for initial clinical trial applications.

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