https://mhrainspectorate.blog.gov.uk/2018/05/31/gcp-symposium-2018/

GCP Symposium 2018

The MHRA GCP Inspectorate will be hosting the annual MHRA GCP Symposium this year on 5th and 6th September 2018 at the Leeds Marriot Hotel, UK. This is a one-day symposium which will be delivered twice on consecutive days.

We have tailored the agenda taking into consideration stakeholder feedback and recent trends/ compliance issues identified on inspections.

Quality Systems, Quality Research – This year’s Symposium will focus on quality systems and associated corrective and preventative actions when things go wrong. The sessions will look at the impact these actions have on the compliant conduct of quality clinical trials research, with a focus on case studies from inspection experience.

Interactive sessions will address the theme and are aimed at providing relevant information to all individuals working on clinical trial activities, in both the commercial and non-commercial setting, focussing on:

  • Quality Systems, Serious Breaches & Corrective and Preventative Action (CAPA)
  • Computer systems validation processes for eSystems;
  • Reference Safety Information (RSI) – Clinical Trials Facilitation Group (CTFG) Guidance Update & Case Studies
  • Joint Food & Drug Administration (FDA) & MHRA Unblinding Session, systems & CAPA
  • Investigational Medicinal Product (IMP) Management – Quality systems, Root Causes and CAPA
  • Forward Look: Inspection Conduct & Processes

Delegates have the opportunity to meet the inspectors and ask questions which can either be submitted beforehand for the panel sessions or can be asked directly during the inspector surgeries. Panel sessions to address questions will be held throughout the day and the inspectors’ surgeries will be available during the refreshment and lunch breaks.

Places are limited. To book your place, please visit the GCP Symposium website

 


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6 comments

  1. Comment by Eldin Rammell posted on

    Last year, the GCP Symposium was preceded by a one-day TMF Forum event, Is MHRA intending to hold a similar event this year and if so, will it be co-located with the GCP Symposium again?

    Reply
    • Replies to Eldin Rammell>

      Comment by Sara Berry posted on

      Dear Eldin, There are currently no plans to hold a TMF day this year, but there is guidance available in Chapter 10 of the MHRA GCP Guide as well as the TMF blog post.
      Kind Regards
      Sara

      Reply
  2. Comment by Betsy Fallen posted on

    There was a reference to an October 23-4 FDA MHRA GCP Workshop on Data Integrity at the DIA Annual Meeting. Is that tentative or confirmed? I have a note it was to be in the US, Maryland.

    Reply
    • Replies to Betsy Fallen>

      Comment by Mandy Budwal-Jagait posted on

      Dear Betty

      Yes, this is confirmed.

      Kind regards,
      Mandy

      Reply
      • Replies to Mandy Budwal-Jagait>

        Comment by Anne posted on

        Dear Mandy,
        Do you know when the meeting will be available for booking onto or if it is already do you have a link to the meeting.
        Many thanks,
        Anne

        Reply
        • Replies to Anne>

          Comment by Mandy Budwal-Jagait posted on

          Dear Anne

          The meeting will available for bookings on the US FDA's website from Monday 10th September 2018.

          Kind regards,
          Mandy

          Reply

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