Glossary

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.

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

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.

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).

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

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

SpanishHealthTechnologyAssessmentbody. http://www.isciii.es/ISCIII/es/contenidos/fd-el-instituto/fd-organizacion/fd-estructura-directiva/fd-subdireccion-general-investigacion-terapia-celular-medicina-regenerativa/fd-centros-unidades/agencia-evaluacion-tecnologias-sanitarias.shtml"

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

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

Romanian National Competent Authority