About

Please note, this event is a repeat of the GCP Symposium which took place in Leeds on 5-6 September 2018. Please do not purchase a ticket if you have already attended the GCP Symposium in September 2018.

'Quality Systems, Quality Research’, is the theme of the MHRA Good Clinical Practice Symposium. The 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.

Keeping up to date with the regulations and providing evidence of the knowledge and training gained is imperative.

Who should attend?

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

Stay focused by engaging with the 2019 topics:

- Unblinding Session, systems & CAPA

- Computer systems validation processes for eSystems

- Inspection Conduct & Processes

- Quality Systems, Serious Breaches & CAPA

- IMP Management – Links to quality systems/ root cause

- RSI – CTFG Guidance Update

 

 

#MHRAGCP19

Twitter

  • Great interactive audience at the MHRA GCP symposium yesterday. Thank you for your participation 😊. I didn’t get to tweet much yesterday but as it was a repeat event, u can see tweets with take home messages from the initial event at #mhragcp18 #MHRAGCP19
  • Not the most orthodox #ValentinesDay yesterday, but really enjoyed #MHRAGCP19 - highlight being asked to look at risks in clinical trials from a patient perspective; "What is the patient's journey on the study? What is the IMP's (study drug) journey?"
  • RT: Common inspection findings relating to RSI are examined by Jennifer Martin and Dr Lisa Campbell at #MHRAGCP19. Including use of documents for expectedness which haven’t been approved by the regulator. Did you know, the MHRA have released blogs on the RSI issue in 2016 and 2017. https://t.co/ufPSpmzThy
  • RT: Andy mentions how we are seeing IRT systems collecting data which is transferred to the CRF, essentially becoming an ECRF as per ICH definition. But the IRT system is not always controlled the same way an eCRF is. #MHRAGCP19
  • RT: Take home message: We need assurances that as patients we are administered what we have been prescribed & that there are processes & controls to ensure our safety. Mandy Budwal-Jagait considers this issue at #MHRAGCP19 Symposium today. https://t.co/0NxJJ8iP3m
  • RT: Andy mentions how we are seeing IRT systems collecting data which is transferred to the CRF, essentially becoming an ECRF as per ICH definition. But the IRT system is not always controlled the same way an eCRF is. #MHRAGCP19
  • RT: Join the discussion at #MHRAGCP19 Symposium today. Andy Fisher addresses the subject of Regulations applying to everyone including specialist vendors providing systems for clinical trials. Do your systems providers know what protocol to follow and when it can be implemented? https://t.co/Df5qxreEk7
  • RT: Take home message: We need assurances that as patients we are administered what we have been prescribed & that there are processes & controls to ensure our safety. Mandy Budwal-Jagait considers this issue at #MHRAGCP19 Symposium today. https://t.co/0NxJJ8iP3m
  • RT: Another resounding success at #MHRAGCP19 Symposium. Positive experience from our national & international delegates, particular highlights on the expertise of speakers & content. Huge thank you to the delegates from MHRA’s GCP team. Stay engaged, keep conversing & collaborating https://t.co/FmEXMP5IXY
  • RT: Take home message: We need assurances that as patients we are administered what we have been prescribed & that there are processes & controls to ensure our safety. Mandy Budwal-Jagait considers this issue at #MHRAGCP19 Symposium today. https://t.co/0NxJJ8iP3m

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 session

    • Dr Andrew Gray, Deputy Director & Group Manager Inspectorate & Process Licensing & Head of UK GLPMA, MHRA
  • 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

  • Refreshments, Networking & Ask the Inspector

  • RSI - CTFG Guidance Update & Case Studies

  • Panel Session

  • Lunch, Networking & Ask the Inspector

  • Unblinding Session, including case studies, systems & CAPA

  • Panel Session

  • Refreshments, Networking & Ask the Inspector

  • IMP Management - Quality systems, root causes & CAPA

  • Forward Look: inspection conduct & processes

  • Panel Session

  • Closing Address

Jason Wakelin-Smith photo

Mr Jason Wakelin-Smith

Lead Senior GCP Inspector, MHRA

Jason joined the MHRA in November 2006 as a GCP Inspector an...
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Jennifer  Martin photo

Ms Jennifer Martin

Lead Senior GCP Inspector, MHRA

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

Ms Gail Francis

Expert GCP Inspector, MHRA

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

Ms Mandy Budwal-Jagait

GCP Inspector, MHRA

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

Ms Paula Walker

Unit Manager, GCP/GPvP/GLP, MHRA

Paula Walker currently works for the MHRA as a Good Clinical...
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Lisa Campbell photo

Dr Lisa Campbell

Medical Assessor, Clinical Trials Unit, MHRA

Dr Lisa Campbell joined the MHRA in July 2013 as a Medical A...
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Andrew Gray photo

Dr Andrew Gray

Deputy Director & Group Manager Inspectorate & Process Licensing & Head of UK GLPMA, MHRA

Andrew joined the MHRA in January 2003 as a GLP inspector. I...
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Andrew Fisher photo

Mr Andrew Fisher

Lead Senior GCP Inspector , MHRA

Andy has a BSc (Hons) in Biology and a MSc in Medical Statis...
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Venue

Park Plaza Victoria
239 Vauxhall Bridge Road
London
SW1V 3EQ

Telephone: 0333 400 6140

Website: Park Plaza Victoria 

Travel

Victoria mainline train underground and bus stations are only a couple of minutes walk from the hotel. 

Parking

Park Plaza Victoria London provides on-site parking for guests. The entrance to the car park can be accessed via the main hotel drive. Please be aware that parking is subject to availability and allocated on a first come, first served basis. 

Car parking charges:

  • Mon–Fri: £25.00 for up to 12 hours
  • Mon–Fri: £30.00 for up to 24 hours

Motorcycle parking charges:
£8.00 for up to 24 hours

Please note that costs are approximate, subject to change and inclusive of VAT.

The hotel’s concierge team can provide additional local car park information. Please contact the team by calling +44 (0) 20 7769 9792 or emailing vppconcierge@pphe.com.

Park Plaza Victoria (Symposium Venue)

239 Vauxhall Bridge Road, London, SW1V 1EQ
Tel: 0844 415 6782
Email: ppvlgroups@pphe.com
Web: https://www.parkplaza.co.uk/london-hotel-gb-sw1v-1eq/gbvictor

A block of bedrooms has been held for Wednesday 13th February 2019 at the rate of £209.00 + VAT.

Delegates can call 0844 415 6782 or email the reservations department at ppvlgroups@pphe.com to make a booking. Please quote the block code GLAS140219 to receive the above rate. 


Holiday Inn Express London Victoria

106-110 Belgrave Road, London, SW1V 2BJ
Tel: 020 7630 888
Email: info@hiexpressvictoria.co.uk
Web: https://www.ihg.com/holidayinnexpress/hotels/gb/en/london/lonve/hoteldetail/events-facilities

The Holiday Inn Express London Victoria hotel is a 10-minute walk from Victoria Station. Free on-street parking is available 6:30pm – 8:30am on weekdays and all weekend. A car park is within walking distance of the hotel.

Subject to availability, rooms are available from Wednesday 13th February through to Thursday 14th February starting at a rate of £158.00 including breakfast and VAT.

To book, please call, e-mail or follow the link using the details provided above.


Z Hotel Victoria

5 Lower Belgrave Street, London, SW1W 0NR
Tel: 020 3589 3990
Email: victoria@thezhotels.com
Web: https://www.thezhotels.com/victoria

Z Hotels provide modern, compact and cleverly designed rooms. You can store your luggage under your bed and make use of dropdown tables, handbag hooks and other space savers. It is located less than 200 metres from Victoria Underground station with access to the Victoria, District and Circle lines.

Subject to availability, rooms are available from Wednesday 13th February through to Thursday 14th February starting at a rate of £149.50 including breakfast and VAT.

To book, please call, e-mail or follow the link using the details provided above.


Grange Rochester Hotel

69 Vincent Square, London, SW1P 2PA
Tel: 020 7828 6611
Email: rochester@grangehotels.com
Web: https://www.grangehotels.com/hotels-london/grange-rochester/

The Grange Rochester Hotel is a 5 minute walk from St James’ Park, Westminster underground as well as Victoria underground bus, coach and rail stations.

There are limited number of Deluxe rooms available from Wednesday 13th February to Thursday 14th February at a rate of £151.98 including breakfast and VAT.

To book, please call, e-mail or follow the link using the details provided above.


Premier Inn London Victoria

82-83 Eccleston Square, Off 55 Gillingham Street, London, SW1V 1PS
Tel: 0871 527 8680
Email: https://www.premierinn.com/gb/en/hotels/england/greater-london/london/london-victoria.html

The Premier Inn London Victoria is located 0.2 miles from London Victoria tube and over ground railway station.

Subject to availability, rooms are available from Wednesday 13th February through to Thursday 14th February starting at a rate of £99.50 including breakfast and VAT.

To book, please call or follow the link using the details provided above.

Register

Please note, this event is a repeat of the GCP Symposium which took place in Leeds on 5-6 September 2018. Please do not purchase a ticket if you have already attended the GCP Symposium in September 2018.