SME workshop: Focus on non-clinical aspects: 03 October 2016
As part of its outreach activities, the SME office hosts educational workshops to increase the regulatory knowledge base of SMEs. This training workshop will provide an overview of non-clinical data requirements for the authorisation of 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. The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations.
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