New Requirements for Clinical Laboratories to Meet GCP

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.

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