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Glossary

Core Value Dossier

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Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Core value dossiers

The Core Value Dossier is a comprehensive information resource which presents all supporting evidence of a particular therapeutic area. The dossier is prepared as a basic outline which can be further customized for submissions to local and national payers.

Core value dossiers in the European Union

Core value dossier are used to pool the results to communicate the added value of a healthcare procedure/product compared to the available solutions on the market. This tool supports the development of global reimbursement strategies as well as the preparation of local HTA/reimbursement dossier for a specific market.

Other glossary definitions

U

Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not…

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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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