The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.
Core Value Dossier
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.
Latest Glossary Definitions
Briefing Book (or briefing materials)
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.
Clinical Impact
The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.
Commercially Confidential Information (CCI)
In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.
Clinical Evaluation Report (CER)
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.
CE-Marking Technical File
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.
Comparative Effectiveness Analysis (CEA)
A systematic evaluation of the evidence on the outcomes of different drugs or other options for treating, preventing, or diagnosing a medical condition.
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, and monitor health conditions in routine clinical practice (i.e. the real-world setting).
Core Value Dossier
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
Core Reimbursement Dossier
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.
