Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Adverse Drug Reaction:

The detection, assessment, understanding and prevention of ADR are the objectives of the Pharmacovigilance.

ADR in the European Union:

  • An ADR is characterized as unintended and noxious responses to a drug and implies a possible causal relationship between the drug and the adverse event. ADR can happen during clinical trials or once the product is on the market.
  • ADR should be distinguished from untoward medical occurrence occurring after drug administration and where a causal relationship between the drug and the medical occurrence is excluded (called. Adverse Event).
  • Non-serious ADRs should be distinguished from the serious ones which can result in death, life-threatening, hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or congenial anomaly / birth defect.

Latest Glossary Definitions

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.

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 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.

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