Eliminate the confusion - New 2012 Requirements for Clinical Laboratories to Meet GCP

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance.

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.

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.