About

‘Quality Systems, Quality Research’, is the theme of the 2018 MHRA Good Clinical Practice Symposium. This year’s Symposium will address quality systems and corrective and preventative actions, the impact these have on the compliant conduct of quality clinical trials research, with a focus on case studies from inspection experience.

The event will provide a unique platform for cross-collaboration and discussion between regulators and members of the commercial and non-commercial research community on the latest hot topics and regulatory updates related to GCP.  Keeping up to date with the regulations and providing evidence of the knowledge and training gained is imperative.


Keep up to date on key trends with sessions on:

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


Who should attend?

These are must attend events for all individuals from the pharmaceutical industry sponsoring and managing clinical trial activities in both the commercial and non-commercial setting.

The GCP symposium will be of interest to all staff working in clinical trials, from those managing and monitoring clinical trials to those involved in reviewing/reporting clinical trial data.

 

Questions for the panel

Once you have registered, you 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. Please include in your submission the name of the speaker you wish to address your question to.

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


CPD

Delegates attending the MHRA GCP Symposium will be eligible to claim CPD points.

Interactive Sessions

There will be interactive sessions at the event via a web browser app and further details will be provided nearer the Symposium.

Agenda

  • Registration & Refreshments

  • Opening

  • Quality Systems, Serious Breaches & CAPA – What does inspection experience tell us?

  • Computer systems validation processes for eSystems; including case studies of Serious Breaches in this area

  • Panel Session

  • Refreshments, Networking & Ask the Inspector

  • RSI – CTFG Guidance Update & Case Studies

  • Panel Session

  • Lunch, Networking & Ask the Inspector

  • Joint FDA & MHRA Unblinding Session, including case studies, systems & CAPA

  • Panel Session

  • Refreshments, Networking & Ask the Inspector

  • IMP Management: Quality systems, Root Causes and CAPA

  • Forward Look: Inspection Conduct & Processes

    • Paula Walker, GCP Operations Manager & Senior GCP Inspector, MHRA
  • Panel Session

  • Closing Address

Speakers

Andrew Gray photo

Andrew Gray

Unit Manager Inspector & Head GLPMA, MHRA

Andrew joined the MHRA in January 2003 as a GLP inspector. I...
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Jason Wakelin-Smith photo

Jason Wakelin-Smith

Lead Senior GCP Inspector, MHRA

Jason joined the MHRA in November 2006 as a GCP Inspector a...
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Balall Naeem photo

Balall Naeem

GCP Inspector, MHRA

Balall joined the Inspections Enforcement and Standards (IE...
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Maria Beatrice Panico photo

Dr Maria Beatrice Panico

Medical Assessor, Clinical Trials Unit, MHRA

Maria Beatrice Panico is currently a Medical Assessor in th...
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Jennifer Martin photo

Jennifer Martin

Lead Senior GCP Inspector, MHRA

Jennifer joined the MHRA in 2006 as a Good Clinical Practic...
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Gail Francis photo

Gail Francis

Expert GCP Inspector, MHRA

Gail joined the MHRA in November 2003 as a GCP Inspector. P...
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Mandy Budwal-Jagait photo

Mandy Budwal-Jagait

GCP Inspector, MHRA

Mandy joined the MHRA in April 2014 as a GCP Inspector and...
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Paula Walker photo

Paula Walker

GCP Operations Manager & Senior GCP Inspector, MHRA

Paula Walker currently works for the MHRA as a Good Clinica...
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Jean Mulinde photo

Dr Jean Mulinde

Senior Advisor, DCCE (Division of Clinical Compliance Evaluation), FDA

Dr. Mulinde is currently the Senior Policy Advisor for the...
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Venue

Leeds Marriott Hotel
4 Trevelyan Square
Boar Lane
Leeds
LS1 6ET

Tel: 0113 236 6366

Website: Leeds Marriott Hotel

Location

A 4-minute walk from Leeds railway station. 

Parking

The Trinity cark park is situated on the right of the Hotel (postcode LS1 4AG). Please validate your ticket at concierge.

Accommodation

Leeds Marriott Hotel (Symposium Venue)

4 Trevelyan Square, Boar Lane, Leeds, LS1 6ET
Tel: 0113 236 6366
Web: https://www.marriott.com/hotels/travel/lbadt-leeds-marriott-hotel/?scid=bb1a189a-fec3-4d19-a255-54ba596febe2

A limited number of rooms are available for 4th and 5th September 2018 at £115.00 per room per night B&B for single occupancy. To book please click on the special weblink below:

Book your group rate for MHRA

Cut-off date for bookings is 7th August 2018.  If you wish to book after this date, this will be subject to availability.


Jurys Inn Leeds

Brewery Place, Brewery Wharf, Leeds, LS10 1NE
Tel: 0161 774 3172 - to book please call this number and speak to Reservations.
Web: https://www.jurysinns.com/hotels/leeds

Rooms are available for 4th and 5th September 2018 at £93.00 per room per night B&B for single occupancy and £103.00 per room per night B&B for double occupancy. To book call the number above and quote ‘MHRA04091800’.  

Cut-off date for bookings is 7th August. If you wish to book after this date, this will be subject to availability.


Holiday Inn Express Leeds City Centre Armouries

Armouries Drive, Clarence Dock, Leeds, LS10 1LE
Tel: 0113 380 4400 (press option 1 or 2 to go through to Reservations).
Web: http://www.hiexleeds.co.uk/

Rooms are available for 4th and 5th September 2018 at £99.00 inc VAT per room per night and includes an express start breakfast. To book call the number above and quote ‘MHR’ or alternatively, email the booking through to groups@hiexleeds.co.uk

Cut-off date for bookings is 7th August 2018.  If you wish to book after this date, this will be subject to availability.


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 £57.00 per night, please contact hotel directly for availability and confirmation of rates.


Hotel Ibis Leeds Centre

2 The Gateway North, Crown Point Road, Leeds, LS9 8BZ
Tel: 0113 245 0725
Web: http://www.ibis.com/gb/hotel-6002-ibis-budget-leeds-centre/index.shtml

Rates from £48.00 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.

Please Note: the event on the 6th is a repeat of the event on the 5th.  You should only register to attend 1 day.

A limited number of Early bird places are available on a first come, first serve basis.

Standard Non Commercial - 5th Sept

Standard Non Commercial - 6th Sept

Standard Industry - 5th Sept

Standard Industry - 6th Sept

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.