Eliminate the Confusion - 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 (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 the 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.
• 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 to 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
• Professionals responsible for contracts

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

Topic Background:

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. Many laboratories are currently not meeting these requirements. It is essential to ensure compliance you are aware of that sponsors and laboratories should have in place to meet these new standards which regulatory inspectors are now inspecting against.

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