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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Kuala Lumpur Hospital. Healthcare in Malaysia is under the purview of the Ministry of Health of the Government of Malaysia. Malaysia generally has an efficient and widespread system of health care, operating a two-tier health care system consisting of both a government-run public universal healthcare system along with private healthcare providers.
The Medical Act 1971 (Malay: Akta Perubatan 1971), is an Act of the Parliament of Malaysia.It was enacted to consolidate and amend the law relating to the registration and practice of medical practitioners and for national purposes to provide for certain provisions with regard to a period of service in the public services after full registration as a medical practitioner; and to make provision ...
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The Clinical Officers (Training, Registration and Licensing) Act No.20 of 2017 is the law that governs the medical practice of a clinical Officer. [28] It establishes the Clinical Officers Council whose functions are to: advise the government on policy matters relating to clinical medicine practice
A clinical pathway is a multidisciplinary management tool based on evidence-based practice for a specific group of patients with a predictable clinical course, in which the different tasks (interventions) by the professionals involved in the patient care are defined, optimized and sequenced either by hour (ED), day (acute care) or visit (homecare).
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
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