New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally 2015

Key Topics

• What parts of GCP apply to clinical laboratories?
• What does GCP and the new guidance require of clinical laboratories?
• 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
• What standards should the laboratory be working to?
• Procedures for sample collection, receipt and application of acceptance/rejection criteria and for the preparation of reagents
• 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
• What is required to ensure quality and appropriateness of methodology in use in any laboratory?
• What documentation should be available – including SOPs, validation, technical agreements
• 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?
• What should be included in the contract between the laboratory and the sponsor?

Who should Attend

• Clinical research associates
• Clinical development managers and personnel
• Quality assurance managers and auditors
• Clinical research archiving and document management personnel
• CROs using laboratories to analyze clinical trial samples
• Clinical development managers and personnel
• Sponsors who have their own laboratories for analyzing clinical trial samples
• Sponsors and non-commercial sponsors
• Laboratories analyzing samples from clinical trials
• Consultants