1993 – Directive 93/42/EEC

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The Directive 93/42/EEC is being published and shall be implemented in national law by the end of 1994. The Directive 93/42/EEC in principle lists the requirements for clinical data pursuant …

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1993 – EN 540

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The standard EN 540 is being published and describes the performance of clinical trials. Standard A technical standard is an established norm in regard to technical or scientific systems. It …