Monday, 4 March 2024, 11:34 AM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
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Advanced therapy medicinal products

Advanced therapy medicinal products (ATMP) are new medical products for human use based on genes (gene therapy), cells (cell therapy), or tissues (tissue engineering). They have huge potential and open the way for new treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer, or muscular dystrophy.

Adverse Drug Reaction

A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility.

Adapted from the Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 3) 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf

Adverse event

Any untoward (not favourable) medical occurrence in a patient, or clinical trial participant receiving a medicine, and which does not necessarily have a causal relationship with this treatment.

Adverse events can therefore be: any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporallyassociated with the use of a medicine, whether or not considered related to the medicine.

Adverse reaction

An adverse reaction, is any adverse event or experience related to a medicine for which a reasonable causal relationship with the medicine™s use is suspected. This is synonymous with adverse drug reaction (ADR).

Aetiology

In medical science it is the study of the causes of diseases and the factors underlying their spread.

Agence Nationale de Sécurité du Médicament et des Produits de Santé

French National Competent Authority. http://ansm.sante.fr/

Agencia de Evaluación de Tecnologías Sanitarias

Agencia Española de Medicamentos y Productos Sanitarios

Spanish National Competent Authority. http://www.aemps.gob.es/

Agencija za lijekove i medicinske proizvode

Croatian National Competent Authority. http://www.halmed.hr/"

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale

Romanian National Competent Authority