Learn compliance requirements for clinical laboratories analyzing samples from clinical trials. Understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

1. New Requirements for Sponsors and Laboratories for
Analyzing Clinical Trial Samples to Meet GCP/GCLP
Internationally
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. 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 (finalized in 2012) which provides
guidance on the standards which will set the gold standard in the EU, US and potentially
internationally.
This session 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. 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 required by laboratories analyzing clinical trial
samples. The session is aimed at both 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 this Webinar:
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.

2. 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 and laboratory during the study for ensuring
clinical trials sample management and analysis meet GCP requirements?
Who will benefit:
This webinar will provide critical assistance to FDA and EMA regulated companies currently
carrying out or preparing to conduct clinical trials for pharmaceutical, biotechnology, and
biologics products using clinical laboratories. It will also be applicable to personnel working in
clinical laboratories.
Clinical Development managers and personnel
Clinical research associates
Clinical Research archiving and document management personnel
Quality assurance managers and auditors
Clinical Development managers and personnel
CROs using laboratories to analyze clinical trial samples
Sponsors and non-commercial sponsors
Sponsors who have their own laboratories for analyzing clinical trial samples
Consultants
Laboratories analyzing samples from clinical trials
For more details visit us at:
https://www.complianceonline.com/ecommerce/control/trainingFocus/~produ
ct_id=703094?channel=Doc_organic