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

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Agenda

  • Registration & refreshments

  • Opening session

  • 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

  • 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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Balall Naeem photo

Mr Balall Naeem

GCP Inspector, MHRA

Balall joined the Inspections Enforcement and Standards (IE&...
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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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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.

Accommodation

Information coming soon

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.

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