About

Who should attend?

These are must attend events for individuals from a regulatory laboratory environment in both commercial, and non-commercial settings. The Laboratories symposium aimed at all individuals involved in the conduct of GLP studies, contract GMP Quality Control activities, and the analysis of samples from clinical trials. In addition, individuals who provide a consultancy or contract service,  for example quality assurance consultants or individuals from contract archiving facilities etc.

Benefits of attending:

  •  Keeping up to date with laboratory regulatory requirements and MHRA expectations.
  •  An opportunity to share concerns and learn directly from the MHRA
  •  Have a comprehensive understanding of the MHRA expectations and how to address and correct actual deficiencies
  •  Opportunities to discuss current hot topics and increase awareness of areas of compliance that monitoring authorities are likely to focus on during routine inspections.
  •  Increase ability to recognise the types of compliance issue that facilities have to deal with on a day to day basis and understand how the regulators address these issues on a case by case basis to maintain acceptable levels of compliance and encouraging innovative and flexible thinking.
  • Opportunities to share concerns and best practice with others
  • Information provided at the event will help you in assessing your own quality systems and potentially identify smart solutions to issues regularly encountered by inspectors
  • Meet the inspectorate teams and have the opportunity to ask questions on specific aspects affecting 

Inspectors Surgeries

Delegates will be able to enquire about arranging an appointment to discuss specific issues with inspectors during the Inspectors Surgery that will take place after the Symposium. This can be done via the registration process. Additionally, inspectors will be available during the breaks throughout the day to answer questions.

 

Mobile App

Have you downloaded the MHRA Event App? Get the most out of the event by downloading the App to your smart phone or device. You will be sent the relevant event code and login details upon registering for the event. The App is available for both Apple and Android, just search 'MHRA Event App' or click on the appropriate link below:

Agenda

  • Registration and networking

  • Opening Session

    • Andrew Gray, Unit Manager, Inspectorate Operations (GCP, GLP, GPvP), MHRA
  • Critical thinking & Risk Management

    • Quality Oversight
    • Data Risks
    • Governance & Responsibilities

    • Andrew Gray, Unit Manager, Inspectorate Operations (GCP, GLP, GPvP), MHRA
    • Stephen Vinter, Operations Manager, GLPMA & Laboratories Group, MHRA
    • Lesley Graham, Lead Senior GLP & GMPQC Inspector, MHRA
  • Coffee break

  • Effective Corrective & Preventive Action

    • Lynsay Hunter, GLP Inspector, MHRA
    • Emma Whale, Senior GCP and GLP Inspector, MHRA
  • Lunch

  • GXP specific streams to discuss current issues and hot topics

    The Symposium splits into three concurrent workstreams for this session

    • Stream 1: Good Laboratory Practice

      Guide to OECD GLP Advisory Document No. 19 on the Management, Characterisation and Use of Test Items.

      Claims of Compliance: Use of Non-GLP Data and extending claims of compliance to non GLP facilities.

      • Martin Reed, GLP Inspector, MHRA
      • Michael McGuinness, GCP & GLP Inspector, MHRA
    • Stream 2: Good Clinical Practice

      Guide to implementing and following the EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.

      • Emma Whale, Senior GCP and GLP Inspector, MHRA
      • Jason Wakelin-Smith, Lead Senior GCP & GLP Inspector, MHRA
    • Stream 3: Good Manufacturing Practice Quality Control

      Getting from “I think” to “I know” – Hypothesis testing for Out Of Specification (OOS) investigations.

      The bigger picture – Impact to patients from QC laboratory issues and inspection findings.

      • Lesley Graham, Lead Senior GLP & GMPQC Inspector, MHRA
      • Christine Gray, GMDP Operations Manager & Senior Inspector, MHRA
  • Coffee break

  • Sample Management

    • Stephen Vinter, Operations Manager, GLPMA & Laboratories Group, MHRA
    • Martin Reed, GLP Inspector, MHRA
  • Panel Session

    MHRA Laboratory Inspectors

  • Closing Address

    • Stephen Vinter, Operations Manager, GLPMA & Laboratories Group, MHRA
  • Inspectors Surgery

Venue

The Queens Hotel
City Square
Leeds
LS1 1PJ

Tel: 0113 243 1323

Website: The Queens

Accommodation

The Queens Hotel (Symposium venue)

City Square, Leeds LS1 1PJ
Tel: 0845 074 0006
Web: https://www.qhotels.co.uk/our-locations/the-queens/

To book please call the central reservations team on 0845 074 0006.

A limited numbers of rooms are available on the 26th February at £97.00 per room per night B&B for single occupancy. To book call the number above and quote ‘MHRAGC050917’

Cut-off date for bookings is 1st January 2018. If you wish to book after this date, this will be subject to availability.


Leeds Marriott Hotel

4 Trevelyan Square, Boar Lane, Leeds LS1 6ET
Tel: 0113 236 6366
Web: http://www.marriott.com/hotels/travel/lbadt-leeds-marriott-hotel/

A limited number of rooms are available for 26th February 2018 at £100.00 per room per night B&B for single occupancy or £110 for double occupancy. To book please click on the special weblink below:

Book your group rate for MHRA

Cut-off date for bookings is 22nd January 2018.  If you wish to book after this date, this will be subject to availability.


Park Plaza Leeds

Boar Lane, Leeds LS1 5NS
Tel: 0844 415 6720
Web: https://www.parkplaza.com/leeds-hotel-gb-ls1-5ns/gbleeds

Rates from £75.00 per night, please contact hotel directly for availability and confirmation of rates.


Travelodge Leeds City Centre

Blayds Court, Blayds Yard, Swinegate, Leeds LS1 4AD
Tel: 0871 984 6155
Web: https://www.travelodge.co.uk/hotels/144/Leeds-Central-hotel

Rates from £40.00-£67.25 per night, please contact hotel directly for availability and confirmation of rates.

Register

In order to register for the event, please click the relevant register button below. Please ensure you have all your details ready.

 

Non-commercial* (Standard)

Industry (Standard)

* The Non-Commercial rate is applicable for Charities / Third Sector / NHS / Government & Academic.

Contact

MHRA have appointed Glasgows to organise the event and host the online registration process.

For more information about other MHRA events please visit the conference and education section of the MHRA website: www.mhra.gov.uk.