Practical Pharmacovigilance for Clinical Trials: Guidance from a UK Regulatory Inspector

Date: November 3, 2010 Time: 11:00 am - 12:30 pm Eastern Time US; Please check your time zone prior to the webinar Registration Deadline: November 2, 2010, 11:59 pm Eastern Time  Contact Hours: CBRN, ACRP Earn 1.5 contact hours (only purchaser eligible to receive contact hours) Member Rate: $99.00 Regular Rate: $124.00

Last 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 fourth webinar and Patricia Moore (Senior Pharmacovigilance Inspector, MHRA) will discuss the pharmacovigilance requirements in place within the UK for clinical trials and provide guidance on the ways in which Sponsors may work to meet these requirements.

As part of this webinar Patricia will cover the basic requirements in place with regards to pharmacovigilance in clinical trials as well as examining the challenges in place when trying to meet the requirements.  This will include a review of the roles and responsibilities of the different groups within the pharmacovigilance system, such as Sponsors and Investigators, as  well as examining how these groups can work together to achieve compliance.  Patricia will also cover some of the common pitfalls for organizations involved in pharmacovigilance of clinical trials.  The overall aim of this webinar is for organisations involved in clinical trials to understand the legal requirements in place within the UK for pharmacovigilance for clinical trials and how best to translate these requirements into practice.

Target Audience
This webinar is intended Sponsors’ responsibilities vary in complexity and both commercial and non-commercial sponsors have similar non-compliance issues. The webinar will be particularly useful for many roles including  Pharmacovigilance Groups, 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, and Primary Care Trusts.

Learning Objectives
Upon completion of this webinar, attendees should be able to:

• Describe  the roles and responsibilities of the different groups involved in clinical trial pharmacovigilance
• Identify three common deficiencies seen during MHRA  inspections
• List two recommendations for changes to be made in order to improve the compliance of their pharmacovigilance system.

Presenter
Patricia Moore is the Operations Manager for a joint Pharmacovigilance and GCP Inspectorate team at the Medicines and Healthcare products Regulatory Agency (MHRA). Patricia joined the MHRA in December 2004 and was promoted to Senior Pharmacovigilance Inspector in October 2007.  In her role Patricia regularly performs both pharmacovigilance and GCP inspections in the UK and overseas as well as contributing to the development of the inspection programme.  Patricia also played a major role in developing the MHRA’s Good Pharmacovigilance Practice Guide (the ‘Purple Guide’) which was published in November 2009. Patricia has an MSc in Clinical Pharmacology and has seven years experience of working in pharmacovigilance within industry, particularly in the area of clinical safety.

Disclosure Statement
Ms. Moore 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 11147-2010-324).

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-324).

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.