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Clinical Trials in Belgium - The Belgian Implementation of the European Clinical Trials Directives (Paperback, 2nd Revised edition)
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Clinical Trials in Belgium - The Belgian Implementation of the European Clinical Trials Directives (Paperback, 2nd Revised edition)
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In line with its strong position in clinical research, Belgium was
one of the first European Member States where the implementing
regulation of the Clinical Trials Directive is fully operational.
The specific conditions provided for in the legislation concerning
experiments on the human person reinforce Belgium as a very
attractive host for clinical trials, ensuring a lasting environment
for innovative research.
Pharma.be, the Belgian Pharmaceutical Industry Association, wants
to contribute its part to research in Belgium by clarifying the
practical implications of the new regulations. This new edition of
the Operational Guidance does not only analyse the Belgian law from
the perspective of the sponsor of a clinical trial, but also
addresses the roles and tasks of all parties involved in clinical
trials. In order to assist everyone involved in clinical trials,
the Guidance provides for a short and comprehensive overview and
insight into the process flows of the submission to and evaluation
by the competent authority and the ethics committee of a clinical
trials application. In addition, standard templates for the most
important documents are added on a cd rom.
This book is extremely useful, both for study sponsors and for all
other actors in the field of medical research and development such
as members of ethics committees, physicians, pharmacists,
administrators, etc.
The first edition of Clinical Trials in Belgium was very soon
qualified as the standard textbook on the new EU legal framework
and its transposition into Belgian law.
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