Regulatory Compliance in UK Laboratories Processing Clinical Trial Samples: Guidance from a UK Regulatory Inspector
| Date: Sept. 29, 2010 |
| Time: 10:00 am - 11:30 am Eastern Time US; Please check your time zone prior to the webinar |
| Registration Deadline: Sept. 28, 2010, 11:59 pm Eastern Time |
Contact Hours: CBRN, ACRP
Earn 1.5 contact hours (only purchaser eligible to receive contact hours) |
| Level: Core |
| Member Rate: $99.00 |
| Regular Rate: $124.00 |
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Second in a series of 4 webinars focused on the UK Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA). A rare opportunity to have your questions directly answered by the inspectors.
Program Description
This webinar will provide a rare opportunity to discuss your queries of Laboratory Compliance directly with Andrew Gray, Head of the United Kingdom Good Laboratory Monitoring Authority within the UK Regulatory Inspectorate Group of the MHRA (Medicines and Healthcare Product’s Regulatory Agency).
Andrew will review the MHRA’s Good Clinical Practice document, "Guidance on the Maintenance of Regulatory Compliance in Laboratories That Perform the Analysis and Evaluation of Clinical Trial Samples," released in June 2009. The primary aim of the presentation will be to provide detailed information on the MHRA's expectations when inspecting laboratories.
The webinar will cover a range of key issues, such as sample shipping and receipt, the organisation and conduct of laboratory analysis, subject confidentiality, blinding and unbinding of clinical samples, expedited reporting of data, and lines of communication between the laboratory and the sponsor or clinical investigators. The webinar will also detail the inspection process with the aim of providing some insight into the inspectors’ expectations. Finally, the presentation will explore some common deficiencies which have been highlighted over the last two inspection cycles.
Target Audience
The webinar will be particularly useful to the following roles working in CROs, SMOs, Pharmaceutical Companies, Investigator Sites, and Central Labs in both the commercial and non-commercial sector: Regulatory Affairs Personnel, R&D Managers, Pharmaceutical Physicians, Laboratory Directors, Laboratory Staff, Investigators, Project Directors, Project Managers, QA personnel, Auditors, Senior CRAs, CRAs/Monitors and Clinical Research Nurses/coordinators (involved sample handling).
Learning Objectives
Upon completion of this webinar, attendees should be able to:
- Describe two key aspects of the MHRA's laboratory guidance document
- State three issues that laboratories will need to consider when performing work as part of a clinical trial
- Describe the inspection process and state two common deficiencies.
Presenter
Andrew J. Gray, BSc, PhD, joined the MHRA in January 2003 as a GLP inspector. In 2004 he was appointed Operations Manager for the Good Laboratory Practise and Good Distribution Practise Groups, taking responsibility for the management of a team of ten inspectors. In May 2006 Andrew took on the role of Head of the United Kingdom Good Laboratory Monitoring Authority. In this capacity he is a member of the OECD, EC & EMA GLP working groups and has contributed to a number of national and international guidance documents. Andrew’s team are also responsible for the inspection of laboratories that perform the analysis of samples generated as part of human clinical trials and was a member of the group that drafted the recent MHRA GCP laboratory guidance document. Prior to joining the MHRA, Andrew worked in both academia and the pharmaceutical industry where he was primarily involved in the early development of drugs designed to treat cardiovascular disease.
Disclosure Statement
Dr. Gray states that he has no actual or potential financial conflict of interest in relation to this program.
Accreditation Information
Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing Nursing education credit (Program Number 11147-2010-322).
Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form. These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2010-WEB-322).
Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.