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The board members consists of the following: (1) There is established a Board which shall consist of— (a) a chairperson who shall be appointed by the President and who shall— (i) be a registered pharmacist of good standing with a degree in pharmacy; and (ii) have at least ten years' experience in the pharmaceutical sector; (b) the Director of pharmaceutical services; (c) the Principal ...
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
The Clinical Officers Council of Kenya (COC) is a government agency – a corporate body created by the Clinical Officers (Training, Registration and Licensing) Act no. 20 of 2017 – Laws of Kenya whose work is to supervise and control the training and professional practice of medicine, dentistry, orthopaedics and health work by clinical officers and to register and license clinics and ...
It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors.
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. [1]
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
Clinical officers play a central role in Kenya's medical sector today. There were 8,600 clinical officers on the register in 2010 compared to 7,100 medical officers. [19] They are trained by the universities, the Kenya Medical Training College (KMTC), [20] St. Mary's School of