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delegate area login username password log in forgot -- toggle navigation about agenda venue accommodation register contact -- 5th september 2017 — the royal armouries museum, leeds learn receive guidance on current legislative requirements and mhra expectations on trial master files (tmfs) discover current tmf challenges and how your organisation could avoid common pitfalls recognise a unique platform for cross-collaboration and discussion between regulators and members of the clinical trials community opportunity to share the experiences of mhra inspectors and inspected organisations using interactive sessions about the mhra gcp tmf focus day will provide a unique platform for cross-collaboration and discussion between regulators and members of the commercial clinical trials community on the requirements and challenges of the trial master file (tmf). due to the interactive nature of this event numbers are limited to 100 places, for this reason registration will initially be limited to one representative per organisation. it is recommended that those attending on behalf of their organisation are involved in managing tmfs/tmf systems to maximise the benefit of this event. who should attend? these are must attend events for individuals from the pharmaceutical industry managing clinical trial essential documentation. we suggest the content may be more suitable for those in the commercial setting due to their extensive use of etmfs. benefits of attending: keep up to date with gcp requirements for the tmf ensure an understanding of the purpose of the tmf learn about the challenges of having a complete inspection ready etmf engage with mhra inspectors in an open way outside of the inspection environment learn/share from experiences of inspected organisations/those implementing or who have implemented an etmf an opportunity to share concerns and best practice with others information provided at the event will help you in assessing your own quality systems and potentially identify smart solutions to issues regularly encountered by inspectors and research professionals discover what your peers are doing through managed interactive sessions meet the inspectorate teams and have the opportunity to ask questions on specific aspects affecting your organisation delegates attending the tmf workshop will be eligible to claim cpd points. to confirm your place immediately, register for this event by paying by credit card today! -- #mhragcp tweets 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 log-in 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 please find below the agenda information for the tmf workshop. gcp tmf focus day 2017 08:00 — 08:45 registration and refreshments 08:45 — 09:00 introduction gail francis , expert gcp inspector, mhra 09:00 — 10:15 inspect part of a tmf – inspector led practical exercise kath meely , senior gcp inspector, mhra andy fisher , senior gcp inspector, mhra 10:15 — 11:00 assessing compliance from documents, data and esystems – inspector led presentation & interactive exercise andy fisher , senior gcp inspector, mhra 11:00 — 11:30 refreshments and mhra inspectors tmf surgeries 11:30 — 12:00 the inspector’s user requirements for tmf – inspector led exercise balall naeem , gcp inspector, mhra 12:00 — 13:00 case studies/experience 1 – what’s (been) wrong with tmfs – is it the same for everyone? vittoria sparacio , head of clinical documentation operations , gsk dr mieke borgs , global head clinical document governance and management, novartis 13:00 — 13:45 lunch and mhra inspectors tmf surgeries 13:45 — 14:45 case studies/experience 2 - fixing the problem within the organisation ivan walrath , head of audit & inspection quality, pfizer lorrie dixon , global trial master file manager, roche 14:45 — 15:30 case studies/experience 3 - fixing the problem - challenges when multiple organisations involved karen roy , senior vice president, client solutions , phlexglobal scott mcculloch , associate director, development sciences quality , biomarin 15:30 — 16:00 refreshments - mhra inspectors tmf surgeries 16:00 — 17:30 challenge of etmfs and way forward? what more can mhra do? why are there still critical findings for etmfs? panel session questions to the panel once you have registered , you have the opportunity to submit pre-event questions. 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 submit your questions, please log into the delegate area or mhra event app and go to panel questions in the menu. venue the royal armouries museum the royal armouries museum, armouries dr, leeds, ls10 1lt tel 0113 220 1999 website: visit 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 holiday inn express leeds city centre armouries armouries drive, clarence dock, leeds, ls10 1le tel: 0113 380 4400 (press option 1 or 2 to go through to reservations). web: click here rooms are available for 4th, 5th & 6th september 2017 at £99.00 inc vat per room per night and includes an express start breakfast. to book call the number above and quote ‘mhr’. cut-off date for bookings is 5th august 2017. if you wish to book after this date, this will be subject to availability. jurys inn leeds brewery place, brewery wharf, leeds, ls10 1ne tel: 0113 283 8802 – to book please call this number and speak to reservations. web: click here rooms available for 4th, 5th & 6th september at £75.00 per room per night b&b; for single occupancy and £85 per room per night b&b; for double occupancy. to book call the number above and quote ‘mhragc050917’. cut-off date for bookings is 7th august. if you wish to book after this date, this will be subject to availability. leeds marriott hotel 4, trevelyan square, boar lane, leeds, ls1 6et tel: 0113 236 6366 web: click here a limited number of rooms are available for 4th, 5th & 6th september 2017 at £140.00 per room per night b&b; for single occupancy. to book please click on the special weblink below: book your group rate for mhra allocation cut-off date for bookings is 7th august 2017. if you wish to book after this date, this will be subject to availability. travelodge leeds city centre blayds court, blayds yard, swinegate, leeds, ls1 4ad tel: 0871 984 6155 web: click here rates from £47.00 per night, please contact hotel directly for availability and confirmation of rates. hotel ibis budget leeds centre 2 the gateway north, crown point road, leeds, ls9 8bz tel: 0113 245 0725 web: click here rates ranging from £33.00 - £52.00 per night, please contact hotel directly for availability and confirmation of rates. register these are must attend events for individuals from the pharmaceutical industry managing clinical trial essential documentation. we suggest the content may be more suitable for those in the commercial setting due to their extensive use of etmfs. in order to register for the event, please click the relevant register button below. please ensure you have all your details ready. a reduced rate will be available to those also booki

URL analysis for mhragcp-tmfworkshop.co.uk

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Whois Information

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Domain name:
mhragcp-tmfworkshop.co.uk

Registrant:
Paul Leaks

Registrant type:
UK Individual

Registrant's address:
5 Centurion Court
Leyland
Lancashire
PR25 3UQ
United Kingdom

Data validation:
Nominet was not able to match the registrant's name and/or address against a 3rd party source on 19-May-2017

Registrar:
123-Reg Limited t/a 123-reg [Tag = 123-REG]
URL: http://www.123-reg.co.uk

Relevant dates:
Registered on: 19-May-2017
Expiry date: 19-May-2019
Last updated: 19-May-2017

Registration status:
Registered until expiry date.

Name servers:
ns.123-reg.co.uk 212.67.202.2
ns2.123-reg.co.uk 62.138.132.21

WHOIS lookup made at 12:45:07 05-Dec-2017

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Copyright Nominet UK 1996 - 2017.

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  REFERRER http://www.nominet.org.uk

  REGISTRAR Nominet UK

SERVERS

  SERVER co.uk.whois-servers.net

  ARGS mhragcp-tmfworkshop.co.uk

  PORT 43

  TYPE domain

OWNER

  ORGANIZATION Paul Leaks

TYPE
UK Individual

ADDRESS
5 Centurion Court
Leyland
Lancashire
PR25 3UQ
United Kingdom
Data validation:
Nominet was not able to match the registrant's name and/or address against a 3rd party source on 19-May-2017

DOMAIN

  SPONSOR 123-Reg Limited t/a 123-reg [Tag = 123-REG]

  CREATED 2017-05-19

  CHANGED 2017-05-19

STATUS
Registered until expiry date.

NSERVER

  NS.123-REG.CO.UK 212.67.202.2

  NS2.123-REG.CO.UK 62.138.132.21

  NAME mhragcp-tmfworkshop.co.uk

DISCLAIMER
This WHOIS information is provided for free by Nominet UK the central registry
for .uk domain names. This information and the .uk WHOIS are:
Copyright Nominet UK 1996 - 2017.
You may not access the .uk WHOIS or use any data from it except as permitted
by the terms of use available in full at http://www.nominet.uk/whoisterms,
which includes restrictions on: (A) use of the data for advertising, or its
repackaging, recompilation, redistribution or reuse (B) obscuring, removing
or hiding any or all of this notice and (C) exceeding query rate or volume
limits. The data is provided on an 'as-is' basis and may lag behind the
register. Access may be withdrawn or restricted at any time.

  REGISTERED yes

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