Glossary

A type of outcome assessment determined by a trained health-care professional after observation of a patient™s health condition.

Cohort studies are used to study how common diseases are, their causes, and their prognoses. Cohorts are groups of people who are selected on the basis of certain characteristics. For example, if exposure to a risk factor such as cigarette smoke is suspected to cause a disease, a cohort can be selected in which one group has been exposed and another group has not. Both groups are then studied for signs or symptoms of disease.

Cohort studies can be prospective (cohorts are identified before any signs of disease and are followed up over time) or retrospective (data is used that has already been collected, possibly over a long period of time).

Cohort studies are a kind of observational study, in which the researcher does not perform any intervention (such as administering a medicine).

Cohort studies are useful when it would be unethical to carry out a randomised controlled trial (RCT). For example, deliberately exposing people to cigarette smoke or asbestos would be unethical and therefore cannot be done.

An uninterrupted series of production, storage, and distribution activities, along with associated equipment and logistics, which maintain a desired low temperature range. It is necessary to maintain the quality and efficacy of certain medicines and vaccines.

Dutch National Competent Authority (English: MEB). http://www.cbg-meb.nl/"

Combined advanced-therapy medicines are medical products based on the combination of genes (gene therapy), cell therapy (cell therapy) or tissues (tissue engineering) with one or more medical devices as an integral part of the medicine.

Belgian Health Technology Assessment body. http://www.riziv.fgov.be/nl/riziv/organen/Paginas/commissie-tegemoetkoming-geneesmiddelen.aspx#.V1rMphM4ViQ"

Belgian commission for reimbursement of medicines. http://www.inami.fgov.be/fr/inami/organes/Pages/commission-remboursement-m%C3%A9dicaments.aspx#.V16FmNKLRD8"

French Health Technology Assessment body. http://www.has-sante.fr/portail/jcms/c_419565/fr/commission-evaluation-economique-et-de-sante-publique"

Committee for Advanced Therapies (CAT) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000266.jsp"

Committee for Medicinal Products for Human Use (CHMP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp"