Wednesday 11 September 2019 - The Midland Hotel

GOOD CLINICAL PRACTICE SYMPOSIUM 2019
(NON-COMMERCIAL)

About

This year’s September Good Clinical Practice (GCP) Symposium is primarily focused towards non-commercial organisations, such as Trusts, Health Boards, Universities and Charities. It will explore hot topics relevant to non-commercial sponsors and to investigator sites. The interactive sessions will address the changing clinical trial environment from paper to electronic collection of data. But also delve into key issues identified related to activities that may be contracted out by non-commercial sponsors and investigator sites. This symposium will be relevant to all individuals working in non-commercial organisations from the sponsor representatives to the investigator teams and support services, focusing on:

  • Electronic Health Records (EHR)
  • Oversight of Investigational Medicinal Product (IMP)
  • Investigator Responsibilities conducted by third Parties
  • Electronic patient reported outcomes (ePRO)
  • Safety reporting for non-commercials
  • GCP Labs


During the event there will be inspectors surgeries where you can meet the inspectors and discuss specific questions you may have as a sponsor or an investigator. There will be a panel session where you can ask your questions to the inspectors and as always the inspectors will be circulating during the breaks where you can informally touch base with them.

For commercial organisations, there will be a GCP symposium which will be held in London early next year. This will be a joint venture between the MHRA and FDA. Please look out for further communications and registration for this event in due course.


Questions For The Panel

Once you have registered, you will have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. You will be issued with login details on your registration confirmation email. The team will endeavour to answer as many of these questions as they can at the event.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.


Twitter - #MHRAGCP19

Agenda

Please note agenda timings are subject to change.

MHRA GCP Symposium — full schedule

Sept 11, 2019 — 09:00 - 17:30

Registration & Refreshments

Welcome & Introduction

Paula Walker — Inspectorate Unit Manager & Lead Senior GCP Inspector, MHRA

Electronic Health Records (EHR)

Paula Walker — Inspectorate Unit Manager & Lead Senior GCP Inspector, MHRA

Gail Francis — Expert Inspector, GCP, MHRA

Morag Ross — Pharmacist Specialist, Care Quality Commission (CQC)

Are your EHRs suitable for documenting GCP compliant clinical trials, an update on the ongoing issues.

Importance of recording clinical trial information in EHR on the ongoing clinical care.

Refreshments & Inspectors Surgery

Oversight of Investigational Medicinal Product (IMP)

Jason Wakelin-Smith — Lead Senior GCP & GLP Inspector, MHRA

How technology is changing the management of IMP, the risk associated with the use of electronic IMP management and prescribing systems.

Investigator Oversight

Mandy Budwal-Jagait — GCP Inspector, MHRA

Has the sponsor organised or contracted an external source to undertake your site activities? What should you consider and how do you demonstrate oversight?

Panel Session

Lunch & Inspectors Surgery

Source Data Reported on Sponsor Systems

Andy Fisher — Lead Senior GCP Inspector, MHRA

Do you host trials that use sponsors systems to capture source trial data? Be aware of what it means for your site and the control of your data.

Safety Reporting for Non-Commercials

Jennifer Martin — GCP Operations Manager & Lead Senior GCP Inspector, MHRA

Beatrice Panico — Senior Medical Assessor, Clinical Trials Unit, MHRA

Do you know your responsibilities for safety reporting from identifying SAEs to reporting SUSARs.

Refreshments & Inspector Surgery

GCP Labs

Michael McGuinness — GLP & GCP Inspector, MHRA

What oversight as the sponsor or Chief investigator do you have for GCP compliance of your labs.

Panel Session

Closing Address

Paula Walker — Inspectorate Unit Manager & Lead Senior GCP Inspector, MHRA

Calendar Download

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Speakers

Register

Upon completion of the registration, an invoice is automatically issued via email to the booker. This includes a secure online credit card payment link and also details of how to make BACS payments etc.

 

* the non-commercial rate is applicable for Charities / Third Sector / NHS / Government & Academic

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Ticket

Standard Non Commercial

£ 295 +VAT

Venue

The Midland Hotel in Manchester has been a much-loved part of this magnificent city's life for over 115 years. Step into its timeless elegance and experience award-winning restaurants and an idyllic urban spa.


For further details regarding parking and directions to The Midland Hotel, please click on the buttons below.

Accommodation