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part of approved EU marketing applications. Clinical trials that are no longer accepted by Western European ethics … committees are approved by the local ethics committees in countries like India, China, Argentina and Russia. Once officially … approved by an ethics committee, there are no obstacles to including the trial in the technical dossier of a marketing …
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This document reflects the views of the High Level Group on the requirements for a Technology Platform. It proposes the launch of such a Platform and provides details of its proposed scope and organisation. This paper will act as a consultation and discussion document for all stakeholders.
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