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EU Regulation of In-Vitro Diagnostics

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The role of IVDs in personalised medicine, the benefit/risk based approach and the market approval for IVDs, which is different from those for medicinal products will be discussed. Differences between the EU and US systems for personalised medicine, and the current and new role of notified bodies, standards and Common Technical Specifications will be addressed.

Exercises will enable you to apply the principles learnt.

Contact your regional office for future dates and locations.
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