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[交流] 【转载】UK-NHS/US-FDA Licensing Medical Products【已搜无重复】

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