The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
Cost-Effectiveness
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.…
glossary
Core Value Dossier
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national…
glossary
Core Reimbursement Dossier
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered…
glossary
Consolidated Parallel Consultation
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs.…
glossary
Conditional Marketing Autorisation
The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than…
glossary
Competent Authority
Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and…
glossary
Compassionate Use
The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to…
glossary
Comparative Effectiveness Research (CER)
The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat,…
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