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

Instructor: Laura Brown
Product ID: 701947
  • Duration: 60 Min

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

Instructor Profile:

Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.

Dr. Brown has 20 years’ experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy. She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007).

She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013).

She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.

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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