UK Regulatory Authority Inspector Discusses Compliance Issues of Sponsor’s Responsibilities
| Date: Oct. 20,2010 |
| Time: 10:00 am - 11:30 am Eastern Time US; Please check your time zone prior to the webinar |
| Registration Deadline: Oct. 19, 2010, 11:59 pm Eastern Time |
Contact Hours: CBRN, ACRP
Earn 1.5 contact hours (only purchaser eligible to receive contact hours) |
| Level: Core-Intermediate |
| Member Rate: $99.00 |
| Regular Rate: $124.00 |
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Third 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
ACRP (UK Office) is working closely with the UK Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate group to deliver 4 educational webinars on areas of concern particularly at Investigator Sites. The Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Enforcement & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation and takes enforcement action where necessary. This is the third webinar, and Gail Francis (Expert Inspector, GCP, MHRA) will discuss the sponsorship issues from the results of the inspection findings of their UK Good Clinical Practice Inspections. Please note the findings cover UK site inspections only.
Directive 2001/20/EC defines a sponsor as an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial. Gail will cover some of the key challenges of Sponsors’ Responsibilities (for both commercial and non-commercial sponsors) at the investigator site. The discussion of inspection findings will also aim to provide recommendations for corrective actions. The aim of the webinar is to learn from the GCP inspection findings, to ensure appropriate documentation of Investigator/Sponsor/CRO responsibilities, improve investigator site communication, oversight and compliance, apply examples to seek to avoid repetition of previous inspection findings, and ensure adherence to the regulations.
Target Audience
Sponsors’ responsibilities vary in complexity and both commercial and non-commercial sponsors have similar non-compliance issues. This webinar will be particularly useful for many roles including Regulatory Affairs Personnel, R&D Directors and Managers, Chief Investigators, Principal Investigators, Project Managers, Trial Managers, Auditors, Senior CRAs, CRAs, Monitors, CRCs, Research Nurses and Administrators working for Sponsors (both commercial and non-commercial), Pharmaceutical Companies, CROs, NHS Trusts, Universities, or Primary Care Trusts.
Learning Objectives
Upon completion of this webinar, attendees should be able to:
- Describe three key challenges of sponsors’ responsibilities in relation to investigator site oversight
- Identify two common findings in relation to sponsor oversight and describe the impact of these issues on patient safety and data integrity
- List two recommendations for corrective actions in relation to sponsoring a clinical trial
Presenters
Gail Francis is an Expert Inspector, GCP, at the Medicines and Healthcare Products Regulatory Agency (MHRA). Gail joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management. Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.
Jenny Black joined the MHRA in March 2006 as a GCP Inspector. Jenny has a BSc in Chemistry and prior to joining the MHRA, Jenny spent about 13 years in the Pharmaceutical industry. She started out in the pre-clinical analytical laboratory working to GLP, then moved into Clinical Research and has held positions as a monitor, CRA/Lead CRA and Project Manager for all types of clinical trials (Phase I through to Phase IV) in both the Pharma and CRO environment.
Disclosure Statement
Ms. Francis states that she 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 11147-2010-323).
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-323).
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.