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Glossary

Data Protection Officer (DPO)

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The primary role of the DPO is to ensure that his organization processes the personal data of its staff, customers, providers or any other individuals (also referred to as data subjects) in compliance with the applicable data protection rules. Regulation EU 2016 /679 which obliges some organizations in EU countries to appoint a DPO for Sponsors.

Other glossary definitions

M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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Q

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.…

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