Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

Latest Glossary Definitions

Efficacy

The measurement of a medicine's desired effect as compared to another healthcare intervention under ideal conditions, such as in a clinical trial.

Effectiveness

The achievement of desired results under the usual circumstances of health care practice.

Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be

Committee for Advanced Therapy (CAT)

The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.

Somatic-Cell Therapy medicinal Products (sCTP)

These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases.

Tissue Engineered Product (TEP)

A human tissue-engineered product (hTEP) means any autologous or allogeneic product which:

 • contains, consists of, or results in engineered human cells or tissues; and

Value Proposition

The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.

Health Economics and Outcomes Research (HEOR)

Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical and life science companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies

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