eudralex
21EUR-Lex — is a service on the official website of the European Union, europa.eu. It provides legal texts of the union.EUR Lex provides direct free access to European Union law. The system makes it possible to consult the Official Journal of the European… …
22Good manufacturing practice — or GMP are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics …
23Regulation (European Union) — For industry and economic regulation laws, see European Community regulation. European Union This article is part of the series: Polit …
24Regulation of therapeutic goods — The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are… …
25List of European Union directives — The following is an incomplete thematic list of European Union directives :Anti discrimination measures*Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic… …
26Biomedical research — (or experimental medicine), in general simply known as medical research, is the basic research or applied research conducted to aid the body of knowledge in the field of medicine. Medical research can be divided into two general categories: the… …
27Harmonization in clinical trials — The word Harmonization comes from Greek word Harmonia the state of the matter or rules when all the parts are fit together. Harmonization is Global Standards that are widely accepted, this principle today is valid for many things.What does the… …
28Clinical research associate — A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of… …
29Validation (drug manufacture) — Within the highly regulated environment for development and manufacturing of Pharmaceutical Drugs and medical devices there is a requirement within the regulations to provide an appropriate amount of assurance that critical processes in producing …
30Title 21 of the Code of Federal Regulations — Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy… …
