Glossary

AE- adverse events

AE is a medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.

ARO-academic research organisation

ARO is an academic institution contracted by a sponsor or a pharmaceutical company to perform one or more research related functions. ARO is well suited to engage a diverse team of academic experts from multiple institutions and its independence from the for-profit entities is assured by public contracts as well as by charters governing academic oversight.

CA- Conditional marketing authorization

For certain categories of medicinal products, in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally required. Conditional marketing authorisations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive (i.e. the conditions of the conditional marketing authorization). In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data. The conditional authorization can be revoked or become a full marketing authorization depending on the results of the confirmatory studies.

CRO- contract research organisation

CRO is an organisation that provides support to the pharmaceutical industry in the form of research services outsourced on a contract basis, such as clinical trials management and pharmacovigilance. Commercial CROs that specialise in clinical trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain staff for this.

Disease-specific post marketing surveillance platform

Disease-specific post marketing surveillance platform collects safety, efficacy, and adverse effect information on all approved medication for a particular disease. A disease based approach is considered efficient as it avoids the need for patients to be entered in multiple databases. If patients switch between treatments then data can be retained. Pharmaceutical companies could gain access to an extra group of control patients and extra comparator information from the existence of a larger registry. This allows adverse effects to be quickly identified as being either drug-specific or disease-specific. Long term data also allows for the potential for the extension of the initial, narrow label.

Drug-specific post marketing surveillance platform

Drug-specific post marketing platform collects safety, efficacy, and adverse effect information on one specific medication. A drug based approach is currently most commonly used and it collects information on only one drug. If patients switch between treatments data is lost if the patients are only enrolled in a drug based database.

EMA- European Medicines Agency

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

FA- full marketing authorization

If a New drug application (in USA) or Marketing authorisation application (in Europe) is successful the product is granted a marketing authorization for several years. However it may be required to renew the approval based on pharmacovigilace data.

FDA - Food and Drug Administration

FDA is a federal agency of the USA Department of Health. This is a regulatory body responsible for regulation and supervision of medicinal and food products. FDA regulates drug development process and grants marketing approvals.

NewCo

The new company that will be set-up to deal with all of the contracting issues relating to the PMS platform. An official name will be given to the company in due course.

PMS – Post marketing surveillance

Post marketing surveillance refers to the collection of data on the safety, including side effects, of a therapy, and data on the effectiveness of the drug to treat the condition (efficacy).

Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The information is provided by the clinicians and patients. The data collection is compliant with EU and other legislation.

SE- side affects

Unintended effect occurring at normal dose related to the pharmacological properties

(U) AR- (unexpected) adverse reaction

A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'. UAR is a not consistent with applicable product information or characteristics of drug.