International Conference on Harmonisation - Good Clinical Practice
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Good clinical practice — is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human… … Wikipedia
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use — The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from… … Wikipedia
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use — Das Ziel der International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ist die Harmonisierung der Beurteilungskriterien von Human Arzneimitteln als Basis der Arzneimittelzulassung… … Deutsch Wikipedia
European Forum for Good Clinical Practice — The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. The EFGCP is committed to the development of the standards for the… … Wikipedia
Good Manufacturing Practice — Unter Good Manufacturing Practice (engl., kurz GMP, dt. „Gute Herstellungspraxis“) versteht man Richtlinien zur Qualitätssicherung der Produktionsabläufe und umgebung in der Produktion von Arzneimittel und Wirkstoffen, aber auch bei Lebens und… … Deutsch Wikipedia
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products — Das Ziel der International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) ist die Harmonisierung der Anforderungen an Arzneimittelzulassungen von Tierarzneimitteln. Es ist ein… … Deutsch Wikipedia
Current Good Manufacturing Practice — Unter GMP (Good Manufacturing Practice, Gute Herstellungspraxis) versteht man Richtlinien zur Qualitätssicherung der Produktionsabläufe und umgebung in der Produktion von Arzneimitteln, Wirkstoffen und Medizinprodukten, aber auch bei Lebens und… … Deutsch Wikipedia
Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… … Wikipedia
Clinical trial protocol — Clinical protocol redirects here. For clinical guidelines not involving trials, see Medical guideline. A clinical trial protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a … Wikipedia
Clinical research coordinator — The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of the Principal Investigator (PI). Good Clinical Practices Principles have been defined by Madelene… … Wikipedia
Clinical site — A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. The foundations for these regulations are … Wikipedia
