Why Should You Attend:

As a result of the FDA and EU Clinical Trials Directive 200/20/EC and subsequent promulgation of laws, EMA inspection and reflection paper in clinical laboratories in the EU covering the conduct of clinical trials in accordance with Good Clinical Practice (GCP), there is the need for laboratories undertaking analysis of samples from clinical trials to comply with GCP regulations and guidance. The standard to be followed by such laboratories is not well defined in FDA and ICH GCP and hence the development of new EMA standards which provides guidance on the standards anticipated which will set the gold standard in the EU and US.

In particular Article 15 of EU Clinical Trials Directive 2001/20/EC provides provision for the inspection of laboratories that perform the analysis or evaluation of samples collected as part of a clinical trial and so companies must ensure the laboratories they use are in compliance with good clinical practice.

The presentation will review the key requirement for compliance for the analysis of samples collected from subjects participating in clinical trials and forms a key part of the clinical trials process. Sample analysis or evaluation provides important data on a range of endpoints which is used, for example, to assess the pharmacokinetic profile of investigational medicinal products and to monitor their safety and efficacy. Consequently, it is essential that sample analysis and evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.

This presentation will explain the new standards which will be required by laboratories analyzing clinical trial samples. The session is aimed at sponsors using clinical laboratories and those at laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that the clinical laboratory operates to a standard that assures the reliability, quality and integrity of the work and results generated.

Areas Covered in the Seminar:

What does GCP and the new guidance require of clinical laboratories?
What parts of GCP apply to clinical laboratories?
What standards should the laboratory be working to?
How to assess a clinical laboratory? Sponsor companies should assess the laboratory before placement to ensure that all aspects of GCP are satisfactorily addressed and that the laboratory standards and methods meet GCP requirements.
Facilities, to assess the orderliness, cleanliness and environmental suitability of premises where study specific activities are to be carried out and the arrangements for storage of materials and samples.
Procedures for sample collection, receipt and application of acceptance/rejection criteria and for the preparation of reagents.
What documentation should be available – including SOPs, validation, technical agreements?
What is required to ensure quality and appropriateness of methodology in use in any laboratory?
What should be included in the contract between the laboratory and the sponsor?
What is the role of the sponsor company during the study?
What should be included in the final reports of the analysis?

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