Tag: GCP

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines

Clinical sites of Karaganda Medical University meet GCP standard

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Ministry of Health of the Republic of Kazakhstan issued a certificate of compliance with the Good Clinical Practice to two clinical sites of RSE on REM “Karaganda State Medical University”

Russia elaborated the GCP Rules for Biomedical Cell Products

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The Ministry of Health of the Russian Federation published its Order “On the Adoption of the Rules of Good Clinical Practice for Biomedical Cell Products.”