Adverse Drug Reaction [ADR]

Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.

EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in the EU.

The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising the information on an investigational medicinal product.

GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.