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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

C

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product,…

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G

Good PharmacoVigilance Practices (GVP) for the European Union

A set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based…

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