Good clinical practiceGood clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software.
European Convention on Human RightsThe European Convention on Human Rights (ECHR; formally the Convention for the Protection of Human Rights and Fundamental Freedoms) is an international convention to protect human rights and political freedoms in Europe. Drafted in 1950 by the then newly formed Council of Europe, the convention entered into force on 3 September 1953. All Council of Europe member states are party to the convention and new members are expected to ratify the convention at the earliest opportunity.
Helsinki AccordsThe Helsinki Final Act, also known as Helsinki Accords or Helsinki Declaration was the document signed at the closing meeting of the third phase of the Conference on Security and Co-operation in Europe (CSCE) held in Helsinki, Finland, between 30 July and 1 August 1975, following two years of negotiations known as the Helsinki Process. All then-existing European countries (except Andorra and pro-Chinese Albania) as well as the United States and Canada, altogether 35 participating states, signed the Final Act in an attempt to improve the détente between the East and the West.
Data Protection DirectiveThe Data Protection Directive, officially Directive 95/46/EC, enacted in October 1995, was a European Union directive which regulated the processing of personal data within the European Union (EU) and the free movement of such data. The Data Protection Directive was an important component of EU privacy and human rights law. The principles set out in the Data Protection Directive were aimed at the protection of fundamental rights and freedoms in the processing of personal data.
Human rightsHuman rights are moral principles or norms for certain standards of human behaviour and are regularly protected in municipal and international law. They are commonly understood as inalienable, fundamental rights "to which a person is inherently entitled simply because she or he is a human being" and which are "inherent in all human beings", regardless of their age, ethnic origin, location, language, religion, ethnicity, or any other status.
General Data Protection RegulationThe General Data Protection Regulation (Regulation (EU) 2016/679, abbreviated GDPR) is a European Union regulation on Information privacy in the European Union (EU) and the European Economic Area (EEA). The GDPR is an important component of EU privacy law and human rights law, in particular Article 8(1) of the Charter of Fundamental Rights of the European Union. It also governs the transfer of personal data outside the EU and EEA.
Biomedical sciencesBiomedical sciences are a set of sciences applying portions of natural science or formal science, or both, to develop knowledge, interventions, or technology that are of use in healthcare or public health. Such disciplines as medical microbiology, clinical virology, clinical epidemiology, genetic epidemiology, and biomedical engineering are medical sciences. In explaining physiological mechanisms operating in pathological processes, however, pathophysiology can be regarded as basic science.
Food and Drug AdministrationThe United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
DrugA drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, suppository, or dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect.
Drug liberalizationDrug liberalization is a drug policy process of decriminalizing or legalizing the use or sale of prohibited drugs. Variations of drug liberalization include: drug legalization, drug re-legalization and drug decriminalization. Proponents of drug liberalization may favor a regulatory regime for the production, marketing, and distribution of some or all currently illegal drugs in a manner analogous to that for alcohol, caffeine and tobacco.
