Description
Good Clinical Practices (GCP) does not provide detailed
requirements regarding the conduct of laboratory activities in
clinical trials. Therefore, laboratories have applied their own
standards to such work drawing from relevant guidance in
other publications, for example ICH in relation to method
validation, GLP relating to preclinical studies and other quality
systems such as ISO standards. At the core of this course is
a collection of basic scientific and management principles
that, if applied, will ensure the credibility of laboratory data.<br><br>
This course draws together information to provide a set of
principles for laboratories dealing with blood chemistry,
haematology or analysis of test drugs in biological matrices,
which will ensure that the data stands up to scrutiny.<br><br>
Practical applications of principles are given maximum priority
in this course through the high level of interactive, dynamic,
problem solving workshops. These mirror situations that the
participants are actually involved in. Solutions to the
workshops require the application of good practices in areas
of regulatory science where guidelines have been unspecified
or unaddressed. The presenters recognize that many courses
can provide information, but information can only be turned
into knowledge through the depth of understanding that
comes from sharing experience and exchanging ideas. This is
why a workshop approach is so valuable.