The MHRA GPvP Symposium Repeat Event
(repeat of the GPvP symposium given in November 2015)

2 September 2016, etc venues St. Paul's London


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Welcome

The MHRA Pharmacovigilance Symposium 2016 is aimed at drug safety representatives from the pharmaceutical industry and academic and quality research organisations 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.

The event will be held at etc venues St. Paul's London.

To confirm your place immediately, register for this event by paying by credit card today!

About

Who should attend?

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

Benefits of attending:

  • Understand how to avoid common deficiencies in inspections by learning from the experiences of others.

  • Gain a greater understanding of pharmacovigilance requirements and MHRA expectations.

  • Improve your organisations pharmacovigilance compliance through learning about enhanced processes.

  • Opportunity to meet, network and share experiences with colleagues and ask questions of the MHRA pharmacovigilance inspectors.

What will be covered?

  • MHRA expectations in relation to self-governance, audits and risk assessments.
  • An update on expectations and the importance of Reference Safety Information and Signal Management.
  • Data Management.
  • Common inspection findings.
  • Update and maintenance of the PSMF.
  • Clinical Trial PV.
  • Other topics to be confirmed nearer the date.

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

Although some aspects of the agenda have been amended, the topics covered and information to be presented at this symposium will be a repeat of the GPvP symposium given in November 2015.


Tweet about the event using #GPvP16

Questions to the panel

Please help us shape the agenda for this year's MHRA GPvP Symposium. Once you have registered, you have the opportunity to shape the event content by submitting pre-symposium questions and topics. The most popular topics/questions will be selected and covered in the presentations or panel session's at the symposium.

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

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Author: Martin Reed

To help GLP organisations pro-actively improve compliance we are sharing the 2015 inspection metrics and examples also seen over the last 12 months

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An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections

Author: Tracy Moore

An update on the use of short notice and unannounced GMP inspections

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Venue

About The Venue

Location

etc. venues St Paul's
200 Aldersgate
London
EC1A 4HD
United Kingdom

Tel: (+44) 020 3735 7700
Web: https://www.etcvenues.co.uk/venues/stpauls

Travel and Access

The venue is conveniently located in the heart of the City, right next to London Wall and the Museum of London. Just 5 minutes from both Barbican and St Paul's tube stations, and 10 minutes from Farringdon and Moorgate. The venue overlooks the Museum of London, so follow signs to the Museum and you will find it right next door.

By Underground

St Paul's - Central Line

On exiting the station follow St Martin Le-Grand north towards Aldersgate Street south towards London Wall and the Museum of London roundabout, the venue is located on the left. Look for the circular artwork in the window and go through the revolving doors.

Barbican - Circle, Metropolitan and Hammersmith & City lines

On exiting the station turn right on to Aldersgate Street. Follow Aldersgate Street south towards London Wall and the Museum of London. As you arrive at the roundabout for Museum of London, the venue is on the right. Cross over the zebra crossing and look for the circular artwork in the windows and go through the revolving doors to reception.

By Train

Aldersgate is located near the Moorgate and Farringdon railway stations, and is around a 10 minute walk from both.

By Bus

The closest bus stop is at the Museum of London and is served directly by the number 4 and 56. Other services also serve Barbican and St Paul's and the venue is a short walk from both the locations.

Parking

The closest car park is located next to the venue at 158-170 Aldersgate Street. Visit www.ncp.co.uk for more details.

Accommodation

London Central Bank Hotel

19-23 St Swithin's Lane
London
EC4N 8AD

Tel: 0871 984 6485
https://www.travelodge.co.uk/hotels/518/London-central-Bank-hotel

15 minute walk from etc venues St. Paul’s
Monument Station is 0.2 miles away
Bank Station is 0.2 miles away
Victoria train/underground station is 3 miles away

Rates from £112 per person per night for a double room. Please contact hotel directly for availability and confirmation of rates.


The Montcalm at the Brewery London City

52 Chiswell Street
London
EC1Y 4SA

Tel: 020 7479 2233
Email: reservations@montcalm.co.uk

20 minute walk from etc venues St. Paul’s
Barbican Station is 0.8 miles away
London Liverpool Station is 0.7 miles away
Victoria train/underground station is 3.7 miles away

Preferential rate for 40 rooms at £220 plus VAT per room per night for Double Deluxe rooms for single occupancy inclusive of full English breakfast. Requests can be emailed to reservations@montcalm.co.uk quoting GLAS010916 or contact the reservations team on 020 7479 2233. Cut-off date for bookings to receive the preferential rate is 23rd July.


Grange St. Paul's Hotel

10 Godliman Street
London
EC4V 5AJ

Tel: 020 7074 1000
Email: stpauls.reservations@grangehotels.com

8 minute walk from etc venues St. Paul’s
Barbican Station is 0.3 miles away
Moorgate Station is 0.3 miles away
Victoria train/underground station is 3.1 miles away

Preferential rate for 30 Superior bedrooms at £159 plus VAT for a double room, Wi-Fi and continental breakfast. In order to access these rates contact the hotel before 4th August on either 020 7074 1000 or email stpauls.reservations@grangehotels.com and quote 010916N.


London Blackfriars Hotel

1-2 Dorset Rise
London
EC4Y 8EN

Tel: 0871 527 9362
http://www.premierinn.com/gb/en/book-a-hotel.html

15 minute walk from etc venues St. Paul’s
St Pauls Station is 0.5 miles away
Mansion House Station is 0.6 miles away
Temple Station is 0.5 miles away
Victoria train/underground station is 2.3 miles away

Rates from £69 per person per night for a double room including VAT. Please contact hotel directly for availability and confirmation of rates using http://www.premierinn.com/gb/en/book-a-hotel.html and entering ‘London Blackfriars’ into the search.

Registration

A limited number of Earlybird rates are available until 5pm, 15th July 2016. Please book early so you don't miss out. Once the allocation of discounted places have been taken, the standard rate will apply.

Early Bird Tickets £495.00 + VAT
Standard Rate Tickets £575.00 + VAT

REGISTER NOW!

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

Please direct all enquiries to Glasgows at the following:

01772 767717

pvinspections@glasgows.co.uk

Glasgows
Unit 5 Centurion Court
Leyland
PR25 3UQ

Alternatively you can use the form opposite