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Glossary

Sensitive Data

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Data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation.

Other glossary definitions

C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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P

Patient Centricity for Biotechs

Priority given to offering an optimal quality of life to patients along all the steps…

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