International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP)

International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP)
Pharmacology: ICH-GCP

Универсальный русско-английский словарь. . 2011.

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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

  • ICH-GCP — International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) ICH GCPClinical studies should be carried out according to International Conference on Harmonisation (ICH) / WHO Good Clinical Practice (GCP) standards. This provides a… …   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

  • 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

  • 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

  • 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 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

  • GCP (стандарт) — Стандарт GCP («Good Clinical Practice», Надлежащая клиническая практика, ГОСТ Р 52379 2005)  международный стандарт этических норм и качества научных исследований, описывающий правила разработки, проведения, ведения документации и отчётности …   Википедия

  • 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


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