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The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: [11] Q: Quality Guidelines; S: Safety Guidelines; E: Efficacy Guidelines; M: Multidisciplinary Guidelines; ICH guidelines are not binding, and instead implemented by regulatory members through national and regional governance. [12]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Caribbean Accreditation Authority for Education in Medicine and other Health Professions (CAAM-HP) is an accrediting body for the education programmes and schools of medicine, dentistry, veterinary medicine, nursing and other health professions in the 15 member nations of the Caribbean Community (CARICOM).
The Medical Council of Jamaica is the licensing body for doctors in Jamaica. Doctors in Jamaica are required to take continuing medical education courses to keep their licences. [1] [2] In 2004, amendments to the country's Medical Act (Jamaica) increased the number of non-doctors on the council. [3]
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
The International Classification of Health Interventions (ICHI) is a system of classifying procedure codes being developed by the World Health Organization (WHO). It is currently available as a beta 3 release. The components for clinical documentation are stable. The component on public health interventions is in the process of being finalized.
This Safety Pharmacology Society (SPS) promotes knowledge, development, application, and training in safety pharmacology. CiPA: Comprehensive in vitro Proarrhythmia Assay (2013) [10] : In the coming years, the FDA plans to update the current regulatory documents for preclinical and clinical safety evaluation of proarrhythmic risk in human (i.e ...
In Jamaica there are over 330 health centers, 24 public hospitals, the University Hospital of the West Indies, a regional teaching institution partially funded by Regional Governments including Jamaica, 10 private hospitals and over 495 pharmacies. There are around 5,000 public hospital beds and about 200 in the private sector.