About
the Book:
Pharmacovigilance is the
science and activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug-related problems.
This introductory guide is
designed to aid the rapid understanding of the key principles of
pharmacovigilance. Packed full of examples illustrating drug safety issues it
not only covers the processes involved, but the regulatory aspects and ethical
and societal considerations of pharmacovigilance.
Covering the basics
step-by-step, this book is perfect for beginners and is essential reading for
those new to drug safety departments and pharmaceutical medicine students. The
second edition is thoroughly revised and updated throughout and includes a new
chapter on clinical aspects of pharmacovigilance.
"This new edition of a
clear and succinct yet comprehensive guide to the field provides exactly the
right introduction for those new to the challenges and the excitement of
pharmacovigilance. It conveys the importance to public health protection of an
effective safety net to pick up new information, and the need for well-planned
strategies to generate new evidence as an enabler of innovation."
-From the Foreword by Dr June Raine CBE, Director of
Vigilance and Risk Management of Medicines, Medicines and Healthcare Products
Regulatory Agency, London, UK and Chair of the EU Pharmacovigilance Risk
Assessment Committee.
Praise for the first edition
"The book is small in size, attractively produced, and... accessible to
all. It does not assume any prior knowledge, yet it also manages to be
informative for those who are already familiar with pharmacovigilance. I
strongly recommend anyone involved with any type of post-marketing medication
research, or any epidemiological study which includes medication use, to read
this interesting little book."
-C. Ineke Neutel, University of Ottawa (Annals of Epidemiology, December 2010) |