<unk>  are applicable to the pharmaceutical industry and medical devices industry. These<unk>  represent the current thinking of<unk>  agencies on a particular subject. It is to be noted that the term<unk> ” is used in the USA, whereas the term “Guidelines” is used in Europe.<unk><unk> , also called government<unk> , is a profession within regulated industries, such as pharmaceutical and medical devices, where professionals such as<unk> ans are expected to implement<unk> <unk> into their work practices.<unk> ans working in a regulated environment (e.g. the pharmaceutical and healthcare industry) are obliged to have a sound knowledge and understanding of the<unk>  requirements that affect the design, conduct, analysis and reporting of their studies.<unk> <unk> for the pharmaceutical and medical devices industry can be found at the international level (e.g. ICH - International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), as well as at the regional/national level; for example: * EMA - European Medicines Agency in Europe, * MHRA - Medicines and Healthcare products<unk>  Agency in UK, * IQWiG - Institute for Quality and Efficiency in Health Care in Germany, * FDA - Food and Drug Administration in USA and * PMDA - Pharmaceuticals and Medical Devices Agency in Japan. Furthermore,<unk> l<unk> <unk> is found under general topics (e.g. Good Clinical Practice - ICH E6(R2)) and specific ones explicitly related to<unk>  (e.g.<unk> l Principles for Clinical Trials - ICH E9 ) or not explicitly (e.g. Special Populations: Geriatrics ICH E7 or Clinical Trial Endpoints in Oncology FDA). This large volume and diversity of<unk> <unk>  (draft and/or final ) is subject to revisions. Therefore, users of the<unk>  are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia content The Wikipedia List of<unk>  provides links to various<unk>  under different topics.
Guidances for statistics in regulatory affairs
Biobank ethics
Glossary of clinical research
International healthcare accreditation
Candidate of Medicine
Guidelines for human subject research
Clinical research ethics
Patient safety organization