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【转载】UK-NHS/US-FDA Licensing Medical Products【已搜无重复】
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The Regulation of Medical Products has been expanded from The Textbook of Pharmaceutical Medicine (Griffin and O’Grady) – the syllabus course book for the Diploma in Pharmaceutical Medicine – and introduces new material into some of the existing chapters, including new chapters and appendices. In early 2002, the British Government agreed to recognise pharmaceutical medicine as an accredited medical specialty. This has necessitated the formalisation of Higher Medical Training (HMT), which leads to the Certificate of Completion of Specialist Training (CCST) with the General Medical Council (GMC). The road to a CCST in pharmaceutical medicine will mean a minimum of two years’ general medical training after full registration by the GMC. Such experience requires clinical care of general medical patients, and two years spent in, for example, histopathology alone would not suffice. This will be followed by at least four years’ experience, during which an ad personum period of specialist training in pharmaceutical medicine would be taken. An integral part of this schedule will be the need to pass the Diploma in Pharmaceutical Medicine after a minimum of two years’ experience in pharmaceutical medicine. This diploma is a knowledge based examination, and as stated previously, The Textbook of Pharmaceutical Medicine has been specifically written to cover the diploma syllabus. Successful completion of the diploma examination allows a candidate to apply for Membership of the Faculty of Pharmaceutical Medicine. Candidates pursuing their CCST will have an ad personum course drawn up for them. All candidates must complete six modules of HMT. Two modules may be taken as some of their “on the job” experience (in whole or in part), and four modules are taught again in whole or in part. The breakdown will depend on the breadth of work experience each person can expect to receive. Exemption from a module may be claimed in some circumstances. For example, a person with a CCST in clinical pharmacology may be exempt from that module, or a person with an MSc in medical statistics may not have to take the statistics module. However, the six modules for HMT will be geared to assess competence as well as knowledge. It is hoped that this book will be a convenient format for use in the module of Medicines Regulation. The book will also be of value to those working in regulatory affairs, prescribing doctors, and pharmacists. http://aromatinisrukas.lt/~guest/cokie/Licensing.Medical.Products.pdf  [ Last edited by cokie on 2004-2-14 at 13:13 ] [ Last edited by zhoukoulk on 2008-11-25 at 21:45 ] |
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