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A Career in Clinical Quality Assurance
A Career in Clinical Quality Assurance
Written by Rita Hattemer-Apostel this
explains that the ultimate task of quality assurance (QA) in clinical research
is to ensure that the trial participants are protected, that valid data is
collected and that reliable conclusions can be drawn.
This is a reprint of Chapter 16 from the
book, Careers with the Pharmaceutical Industry - 2nd Edition which was
edited by Dr Peter D. Stonier and comprises 27 chapters contributed by
individual experts in their fields. Each chapter provides a valuable overview
of a different role and helps the reader understand the qualifications
required, career options and sources of further reading.
PREFACE to
the book - 2nd Edition by Dr Peter D. Stonier
The first edition
of this book appeared in 1994 and has been received favourably enough since to
warrant a second edition some nine years later. The original title 'Discovering
New Medicines' appeared a little opaque for those seeking to learn about
careers in medicines research and development. So for this second edition the
opportunity has been taken to say it as it is: Careers with the
Pharmaceutical Industry. This reflects careers both in the industry,
which in the UK employs some 60,000 people, and those supporting, servicing and
regulating the industry in its contribution to medicines research, representing
up to 250,000 people, in academia, healthcare, government, contract research
and consultancy.
As before, it is not possible to cover all the variants
of jobs and careers that exist in this complex and evolving industry; notably
absent is the manufacturing sector, business management and administration.
However, it is hoped there are enough entry points that are recognisable, so
that light is thrown on the different career courses in pharmaceuticals, at the
core of which are research and development, marketing and sales.
Nine
years is not long in the life-cycle of a pharmaceutical product in that it
takes on average 12 years to develop a new medicine from promising new
molecules discovered in the laboratory, and those that were early in
development when this book first appeared are only now being introduced onto
the market for the benefit of patients. The principles of consistent endeavour
by professionals achieving incremental progress in knowledge and technical
application in new products, which were laid out in the preface to the first
edition, are still valid today.
Nevertheless, throughout the 1990s and
2000s there have been many changes in the environment of medicines research;
changes in philosophy, direction, organisation, communication, financing and
regulation. Much of this perhaps reflects a natural competitive evolution of
renewal and re-engineering, responding to the economic business cycle and to
the relative merits and successes of individual products, as well as to the
potential of future product pipelines. The mapping of the human genome, the
growth of information technology through increased computing power and
communications via the Internet, and the globalisation of medicines R&D to
international standards are just some of the changes which will have a major
impact on the way we both perceive and conduct discovery research, development
and marketing of medicines long into the future.
Change in the business
environment and employment, in this as in many industries, means that the
concept of jobs for life has been replaced by the need to acquire transferable
skills through continuing education and training, and to accept greater
flexibility and mobility in career development. Today, temporary project team
membership in a matrix organisation can lead to as much goal attainment and job
satisfaction as vertical promotion through the organisation did
yesterday.
This book sets out to interest those seeking information
about a career in medicines R&D, one of our most challenging, stimulating
and successful industrial activities. It is hoped it will also be of interest
to those already engaged in one area, who seek career development or a move to
another sector either within or outside a pharmaceutical company. As before, it
might also interest those observers who seek to be informed about how medicines
are discovered and developed and the activities of those working in the
field.
A Career in Clinical Quality Assurance
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