About

The MHRA Pharmacovigilance Symposium 2018 is aimed at drug safety representatives from the pharmaceutical industry and pharmacovigilance service providers who wish to understand how to avoid common inspection deficiencies, by learning from the experiences of others; delegates can expect to gain a greater understanding of new and existing pharmacovigilance requirements, and to understand the MHRA expectations in order to improve their organisations' compliance with pharmacovigilance requirements.


Who Should Attend?

The event is relevant to anyone working in pharmacovigilance across all types of organisations, including EEA Qualified Persons responsible for pharmacovigilance (QPPVs), pharmacovigilance service providers and drug safety and regulatory affairs representatives from the pharmaceutical industry.  

What will be covered?

Delegates can expect to gain a greater understanding of MHRA position and expectations, common inpsection findings, criitical pharmacovigilance processes and maintaining quality management systems to support pharmacovigilance activities.

The agenda will include the following topics:

  • Changing face of pharmacovigilance inspections
  • Inspection findings and trends
  • Additional risk minimisations measures
  • Brexit Update
  • Service providers and outsourcing
  • Signal detection in Eudravigilance
  • Post authorisation safety studies


Why attend?

  • Hear about common inspection findings and how to avoid them
  • Increase understanding of pharmacoviglance requirements
  • Improve pharmacovigilance compliance
  • Networking opportunity
  • Opportunity to ask inspector's questions directly

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 & Refreshments

  • Welcome and Updates

    • Andrew J. Gray, Unit Manager GLP/GCP/GPvP, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Changing face of pharmacovigilance inspections

    • Jo Harper, Expert Inspector in Pharmacovigilance, Medicines and Healthcare products Regulatory Agency (MHRA)
    • Mandeep Rai, Pharmacovigilance Inspectorate Operations Manager & Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Inspection findings and trends

    • Mandeep Rai, Pharmacovigilance Inspectorate Operations Manager & Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Refreshment break and Inspectors Surgery

  • Additional risk minimisation measures

    • Claire Longman, GPvP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
    • Shahin Kauser, Lead Senior Scientific Inspector, MHRA
  • Brexit Update

    • Mark Birse, Deputy Director, Inspection, Enforcement & Standards Division & Head of Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Panel Session

    • Mark Birse, Deputy Director, Inspection, Enforcement & Standards Division & Head of Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Lunch and Inspectors surgery

  • Service providers and outsourcing

    • Anna Adams, Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Post authorisation safety studies

    • Kiernan Trevett, Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Refreshment break and Inspectors Surgery

  • Signal detection in Eudravigilance

    • Rory Littlebury, Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
    • Phil Tregunno, Interim Group Manager, Vigilance Intelligence and Research Group (VIRG), MHRA
  • Panel Session

    • Andrew J. Gray, Unit Manager GLP/GCP/GPvP, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Close

    • Mandeep Rai, Pharmacovigilance Inspectorate Operations Manager & Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
  • After hours inspectors surgery

Questions to 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.

Speakers

Andrew J. Gray photo

Andrew J. Gray

Unit Manager GLP/GCP/GPvP, Medicines and Healthcare products Regulatory Agency (MHRA)

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

Jo Harper

Expert Inspector in Pharmacovigilance, Medicines and Healthcare products Regulatory Agency (MHRA)

Jo Harper is MHRA’s Expert Inspector in Pharmacovigila...
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Mandeep Rai photo

Mandeep Rai

Pharmacovigilance Inspectorate Operations Manager & Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Mandeep Rai initially joined the MHRA as a Good Clinical Pra...
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Claire Longman photo

Claire Longman

GPvP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Claire joined the MHRA as a Pharmacovigilance Inspector in J...
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Mark Birse photo

Mark Birse

Deputy Director, Inspection, Enforcement & Standards Division & Head of Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA)

Mark joined the MHRA in 2002 and is currently the Group Mana...
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Anna Adams photo

Anna Adams

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Anna joined the MHRA as a Pharmacovigilance Inspector at the...
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Rory Littlebury photo

Rory Littlebury

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Rory has extensive experience of the regulators environment,...
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Kiernan Trevett photo

Kiernan Trevett

Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Kiernan Trevett has worked as a GPvP Inspector at the Medici...
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Catharine Raitt photo

Catharine Raitt

Pharmacovigilance & GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Catharine joined the Inspectorate in 2010 and has experience...
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Sophie Radicke photo

Sophie Radicke

GPvP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

Sophie joined the GPvP Inspectorate in January 2018 after ha...
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Phil Tregunno photo

Phil Tregunno

Interim Group Manager, Vigilance Intelligence and Research Group (VIRG), MHRA

Phil is Interim Group Manager of the MHRA's Vigilance In...
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Shahin Kauser photo

Shahin Kauser

Lead Senior Scientific Inspector, MHRA

Shahin graduated from Liverpool John Moores University with...
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Venue

Novotel London West
1 Shortlands
London
W6 8DR

Tel: 020 8741 1555

Website: Novotel London West

Location

With 3 of London's main tube lines within a 3 minute walk of the hotel, as well as numerous 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 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

Novotel London West (Symposium Venue)

One Shortlands, Hammersmith, London, W6 8DR
Tel: 020 8741 1555
Email: h0737-re@accor.com
Web: www.novotellondonwest.co.uk

The hotel are offering a limited number of single occupancy rooms on Weds 2nd and Thurs 3rd May at the rate of £145 per person per night, including breakfast and VAT (£10.00 will apply for double occupancy).

To book, please call or email the hotel and quote "Glasgows Conference" to access these rates.  Bookings must be made by 4th April - after which this offer will be void. 


Best Western Plus Seraphine Hammersmith Hotel

84 King Street, Hammersmith, London, W6 0QW
Tel: 020 8600 0555
Email: Hammersmith@seraphinehotel.co.uk
Web: www.seraphinehammersmith.co.uk

The Best Western Plus Seraphine Hammersmith Hotel is located on King Street just a few minutes’ walk from the Hammersmith Tube and bus stations. The hotel is approximately a ten minute transfer by public transport to the Novotel London West.

The hotel are offering a limited number of rooms on Weds 2nd and Thurs 3rd May at the rate of £119 per person per night, inclusive of room, breakfast, Wi-Fi, bottle of water and VAT.

To book, please call or email the hotel and quote "GLOS" to access these rates.  Bookings must be made by 20th March - after which this offer will be void. Payment is by credit card, 14 days prior to the date of arrival. Cancellation notice 14 days before the date of arrival.


Holiday Inn Express London Hammersmith

120-124 King Street, London. W6 0QU
Tel: 0871 902 1621
Email: info@expresshammersmith.co.uk
Web: www.expresshammersmith.co.uk

A modern London hotel offering free WIFI and an inclusive breakfast buffet and six minutes’ walk from Hammersmith underground station.

Subject to availability, rooms are available on Weds 2nd and Thurs 3rd May 2018 starting at a rate of £150.35 including breakfast and VAT.

To book, please call or email the hotel directly using the contact details above. 


Copthorne Tara Hotel London

Scarsdale Place, Kensington, London, W8 5SY
Tel: 020 7937 7211
Email: reservations.tara@millenniumhotels.co.uk
Web: www.millenniumhotels.com

Contemporary four-star hotel in prestigious Kensington, located just a two minutes’ walk from High Street Kensington underground station. 

Subject to availability, rooms are available on Weds 2nd and Thurs 3rd May 2018 starting at a rate of £107.52 per night (room only) including VAT.

To book, please call or email the hotel directly using the contact details above.


Ibis London Shepherd's Bush

3-5 Rockley Road, London, W14 0DJ
Tel: 020 7348 2020
Email: H7813@accor.com
Web: www.accorhotels.com

Subject to availability, rooms are available on Weds 2nd and Thurs 3rd May 2018 starting at a rate of £151.00 (Room only) including VAT.

To book, please call or email the hotel directly using the contact details above. 

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 4th is a repeat of the event on the 3rd.  You should only register to attend 1 day.

A limited number of Early bird places are available until 5pm on Thursday 22nd February 2018.

Standard Industry - 4th May 2018

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.