Laboratory Analysis in Clinical Trials

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.