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Glossary

Redaction

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In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. The redaction should appear as a light blue box with a black ‘PPD’ label or as a black box with a red ‘CCI’ label.

Other glossary definitions

H

Health Economic Model

A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g.…

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A

Antimicrobial Resistance (AMR)

Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial…

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