Course offering number:0709-410
Course ID:
2137
Laboratory Analysis in Clinical Trials
September 24-25, 2007
New Brunswick, NJ
Who Should Attend
This course is for professionals involved in analytical activities
as part of clinical trials. The course is designed for:-
Persons working in laboratories performing analysis of biological samples from clinical trials
- Monitors or investigators involved in clinical trials
- Persons involved in assessing or selecting clinical laboratory facilities to perform analysis
- Quality Assurance personnel
Participants may come from the pharmaceutical industry,
government institutions, hospitals, academic organizations or
contract facilities.
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.
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.
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.
Other Courses of Interest
ADME Fundamentals
Analytical Methods Validation for FDA Compliance
Sep 14 2009, Burlingame, CA
Analytical Methods Validation for FDA Compliance
Nov 02 2009, Dublin, Ireland
CMC Submissions in CTD Format
Aug 03 2009, New Brunswick, NJ
CMC Submissions in CTD Format
Sep 17 2009, Amsterdam, The Netherlands
Early Stage Clinical Studies for Drugs and Devices
Fragrance and the Mind
AN ON-DEMAND ONLINE TRAINING FORMAT
INDs/NDAs/CTDs
Sep 14 2009, New Brunswick, NJ
Preparation, Packaging and Labeling of Clinical Trial Materials
Jul 08 2009, Amsterdam, The Netherlands
Selecting and Managing CROs
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