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Glossary

Data Protection Representative (DPR)

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The DPR is the EU representative of non- EU Sponsors that are not established in the EU (do not have an affiliate) and process sensitive data during clinical trials. DPR is mandatory for every non-EU sponsor conducting clinical trials within the European Area.

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

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