About

The GMP event is ideal for pharmaceutical industry professionals in quality control and quality assurance, regulatory and compliance involved in manufacturing medicines and is complemented by the GDP event which covers distribution aspects.

The GDP event is suitable for small, medium or large wholesalers and would benefit managers and key staff members involved in procuring, supplying, exporting, and storing medicines as well as Responsible Persons.

The events will provide latest information and guidance on changing legislation and increasing complexity in the manufacturing and distribution chain. The symposia will offer a highly interactive ‘hands on’ learning experience; detailed workshop sessions will review actual sample deficiencies found by regulators and explain how to address and improve compliance in these critical areas.

Delegates attending the MHRA GMDP symposium will be eligible to claim CPD points.

Benefits of attending:

  • gain greater knowledge of the quality issues affecting your organisation
  • have a clear understanding of your key QP and RP responsibilities and accountabilities with a clear focus on the legal and compliance aspects
  • gain detailed knowledge on the best in class standards of GDP and GDP and why is it so essential for patient safety
  • recognise commonly seen GMP/GDP deficiencies and learn how to improve compliance in your organisation
  • be familiar with new GMP and GDP guidelines as covered by EU directives/regulations and guidelines
  • have a comprehensive understanding of the MHRA expectations and how to address and correct actual deficiencies
  • an opportunity to share concerns and learn directly from the MHRA
  • discover what your peers are doing through managed workshops and network with like-minded professionals
  • meet the experts: attend break-out sessions with key speakers.

The event will be held at the Glasgow Hilton. Please click here for further information and to register for this event.

Agenda

Welcome to the Agenda. You will see a tab for each day on the left.
The GDP Symposium is on 6th December and then repeated on 8th December.
The GMP Symposium is on 7th December and then repeated on 9th December.

  • Registration and refreshments

     
  • Welcome

    Speaker: Richard Andrews

  • Regulatory Update

    Speaker: George Collins

  • International Coalition Update

    Speaker: Mark Birse

  • Refreshments

     

  • Data Integrity — another look at an old issue

  • Inspection Action Group & Compliance Management Team Update

  • Lunch

     

  • Q&As to the MHRA panel

    Speaker: Richard Andrews

  • Deficiency Data Update

    Speaker: Vivian Rowland

  • Refreshments

     

  • Investigation of Anomalies

    Speaker: Ewan Norton

  • Q&As to the MHRA panel

    Chairing: Richard Andrews

  • Closing address

    Speaker: Richard Andrews

  • End

     
  • Registration and refreshments

     
  • Welcome & Latest Changes within the Inspectorate

    Speaker: Andy Gray

  • Introduction to Symposium

    Speaker: Claire Glenister

  • Working with other Regulators

  • The Role of Enforcement within the Legitimate Supply Chain, including FMD Update

  • Refreshment / Networking break and Inspectors Surgery

     
  • International Trade and Export

    Speaker: Jane Sewell

  • Errors, Event Chains and Deviation Management (Interactive)

  • Lunch and Inspectors Surgery

     
  • Defective Medicines and Recalls

  • Company factors and the impacts on GDP compliance (Interactive) — Part 1

  • Refreshment / Networking break and Inspectors Surgery

     
  • Company factors and the impacts on GDP compliance (Interactive) — Part 2

    Speaker: Philip Neale

  • The Risk Quiz

  • Closing remarks

  • After hours inspectors’ surgery

    GDP Inspectors

Questions to the panel

Once you have registered, you have the opportunity to submit pre-symposium questions. The MHRA Inspector team will endeavour to answer as many of these questions as they can at the Symposium.

To submit your questions, please log into the delegate area, using the email address you registered with and the password emailed to you upon completion of your registration.

Meet The Speakers

GMP Speakers

Richard Andrews

Unit Manager Inspectorate Operations GMP / GPvP

Richard joined the MHRA as a GMP Inspector in 2001 and is currently a Unit Manager with responsibility for the GMP and GPvP Inspection teams. ..
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George Collins

Bio Available Soon
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Mark Birse

Group Manager, Inspectorate

Mark joined the MHRA in 2002 and is currently the Group Manager for the Inspectorate which comprises of over 80 Inspectors. ...
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David Churchward

Expert GMDP Inspector

David has been a GMP inspector with the UK Medicines and Healthcare Products Regulatory Agency since 2004....
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Graham Carroll

Bio Available Soon
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Andrew Hopkins

Senior GMDP Inspector

Andy has been with the MHRA since March 2005 as a GMP Inspector and became a Senior GMP Inspector 2009. ...
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Alan Moon

Bio Available Soon
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Vivian Rowlands

GMDP Inspector

Vivian joined the MHRA as a GMP Inspector in 2009. She has inspected in sterile and non-sterile manufacturing operations. ...
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Ewan Norton

GMDP Inspector

Ewan joined the MHRA as a GMP inspector in January 2013. Prior to joining the Agency he worked in the Pharmaceutical industry...
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GDP Speakers

Andy Gray

Unit Manager Inspectorate Operations

Andrew joined the MHRA in January 2003 as a GLP inspector. In 2004 Andrew was appointed Operations Manager for the Good Laboratory...
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Claire Glenister

GDP Inspector

Claire joined the agency as a GDP Inspector in January 2013 and has a background in pharmaceutical manufacturing and auditing of 15 years. ...
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Tony Orme

Senior GDP Inspector

A founder member of the GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full...
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Gaynor Brummitt

GDP Inspector

Gaynor joined the MHRA as a GDP Inspector in May 2009 formally working in the pharmaceutical wholesale distribution industry for over...
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Peter Blundell

GDP Inspector

Peter is a pharmacist by profession and joined the MHRA in January 2013. Prior to joining the MHRA, Peter had worked in the pharmaceutical...
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Terry Madigan

GDP Inspector

Terry is an Inspector within the GDP Inspectorate at the Medicines and Healthcare products Regulatory Agency (MHRA). He joined the Agency...
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Bernadette Wilson

GDP Inspector

Bernadette is a GDP Inspector and joined the MHRA in March 2005. Her previous experience includes local government enforcement duties within a Trading Standards...
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Naseem Hudroge

Bio Available Soon
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Cheryl Blake

Senior GDP Inspector

Cheryl joined the MHRA as a GDP inspector in 2005. Cheryl is a Chartered Chemist and spent many years working within industry as a research...
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Madeleine Ault

Senior GDP Inspector

Madeleine is a senior GDP inspector and joined the MHRA in August 2009. Her previous experience includes NHS pharmacy manufacturing...
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Jane Sewell

Bio Available Soon
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Sandra Bax (DMRC)

Bio Available Soon
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Phil Neale

GDP Operations Manager

Philip joined the MHRA in the Pharmacovigilance Inspectorate in July 2009, based at the Welwyn Garden City office. In 2010 he...
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Peter Coombs

Operations Manager, GDP Inspectorate

Peter joined the MHRA in 1993, having spent the previous three years with the Department of Health and NHS Management Executive in Leeds. ...
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Jacqueline Masayi

GDP Inspector

Jacqueline joined GDP in 2011, having previously worked as a Scientific Assessor in the MHRA Licensing Division...
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Venue

Novotel London West

1 Shortlands, London W6 8DR
Tel 020 8741 1555
Website: www.novotellondonwest.co.uk

Location

With 3 of London's main tube lines within a 3 minute walk of the hotel, as well as innumerate bus lines, Novotel London West is an ideal base to reach corporate offices or the Capital's main shopping areas. Located just off the A4 and outside the Central London Congestion ZoneLocated just off the A4 and outside the Central London Congestion Zone, the hotel is just a 20 minute drive from London Heathrow.

Parking

Novotel London West offers over 240 on-site car parking spaces (charged at £1.50 per hour for hotel residents) and 5 coach bays, all of which are secure and under cover. For enquiries please call +44(0)208 2377 540.

Accommodation

Information available shortly...

Register

A limited number of Earlybird rates are available until 5pm, 3rd October 2016. Please book early so you don't miss out. Once the allocation of discounted places have been taken, the standard rate will apply.

Earlybird Single Day

£495 + VAT
  • GMP or GDP Tickets.
    Limited availability until 5pm, 3 Oct 2016
  • Register

Earlybird Combined

£795 + VAT
  • GMP & GDP Combined Tickets.
    Limited availability until 5pm, 3 Oct 2016
  • Register

Standard Single Day

£575 + VAT

Standard Combined

£875 + VAT

Contact Us

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.