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delegate area login username password log in forgot password toggle navigation about agenda speakers venue accommodation register contact mhra good clinical practice 2018 leeds - 5th-6th september 2018 - leeds marriott hotel learn receive guidance on current legislation and oversight of clinical trials including risk adaption discover current trends in gcp inspection findings and how your organisation can avoid common pitfalls recognise current mhra gcp hot topics and areas for organisational improvements opportunity meet the experts in the field and pose questions to the panel about ‘quality systems, quality research’, is the theme of the 2018 mhra good clinical practice symposium. this year’s 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. the event will provide a unique platform for cross-collaboration and discussion between regulators and members of the commercial and non-commercial research community on the latest hot topics and regulatory updates related to gcp. keeping up to date with the regulations and providing evidence of the knowledge and training gained is imperative. keep up to date on key trends with sessions on: - joint food & drug administration (fda) & mhra unblinding session, systems & corrective and preventative action (capa) - computer systems validation processes for esystems - inspection conduct & processes - quality systems, serious breaches & corrective and preventative action (capa) - investigational medicinal product (imp) management – quality systems & root causes - reference safety information (rsi) – clinical trials facilitation group (ctfg) guidance update who should attend? these are must attend events for all individuals from the pharmaceutical industry sponsoring and managing clinical trial activities in both the commercial and non-commercial setting. the 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. questions for 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. cpd delegates attending the mhra gcp symposium will be eligible to claim cpd points. tweets by mhragovuk interactive sessions there will be interactive sessions at the event via a web browser app and further details will be provided nearer the symposium. agenda agenda 08:30 registration & refreshments 09:15 opening andrew gray , unit manager inspector & head glpma, mhra 09:30 quality systems, serious breaches & capa – what does inspection experience tell us? jason wakelin-smith , lead senior gcp inspector, mhra 10:00 computer systems validation processes for esystems; including case studies of serious breaches in this area balall naeem , gcp inspector, mhra 10:45 panel session 11:00 refreshments, networking & ask the inspector 11:30 rsi – ctfg guidance update & case studies dr maria beatrice panico , medical assessor, clinical trials unit, mhra jennifer martin , lead senior gcp inspector, mhra 12:15 panel session 12:30 lunch, networking & ask the inspector 13:30 joint fda & mhra unblinding session, including case studies, systems & capa dr jean mulinde , senior advisor, dcce (division of clinical compliance evaluation), fda gail francis , expert gcp inspector, mhra 14:30 panel session 15:00 refreshments, networking & ask the inspector 15:30 imp management: quality systems, root causes and capa mandy budwal-jagait , gcp inspector, mhra 16:00 forward look: inspection conduct & processes paula walker , gcp operations manager & senior gcp inspector, mhra 16:30 panel session 16:50 closing address andrew gray , unit manager inspector & head glpma, mhra gail francis , expert gcp inspector, mhra speakers andrew gray unit manager inspector & head glpma, mhra andrew joined the mhra in january 2003 as a glp inspector. i... read more jason wakelin-smith lead senior gcp inspector, mhra jason joined the mhra in november 2006 as a gcp inspector a... read more balall naeem gcp inspector, mhra balall joined the inspections enforcement and standards (ie... read more dr maria beatrice panico medical assessor, clinical trials unit, mhra maria beatrice panico is currently a medical assessor in th... read more jennifer martin lead senior gcp inspector, mhra jennifer joined the mhra in 2006 as a good clinical practice... read more gail francis expert gcp inspector, mhra gail joined the mhra in november 2003 as a gcp inspector. p... read more mandy budwal-jagait gcp inspector, mhra mandy joined the mhra in april 2014 as a gcp inspector and... read more paula walker gcp operations manager & senior gcp inspector, mhra paula walker currently works for the mhra as a good clinica... read more dr jean mulinde senior advisor, dcce (division of clinical compliance evaluation), fda dr. mulinde is currently the senior policy advisor for the d... read more venue leeds marriott hotel 4 trevelyan square boar lane leeds ls1 6et tel: 0113 236 6366 website: leeds marriott hotel location a 4-minute walk from leeds railway station. parking the trinity cark park is situated on the right of the hotel (postcode ls1 4ag). please validate your ticket at concierge. accommodation leeds marriott hotel (symposium venue) 4 trevelyan square, boar lane, leeds, ls1 6et tel: 0113 236 6366 web: https://www.marriott.com/hotels/travel/lbadt-leeds-marriott-hotel/?scid=bb1a189a-fec3-4d19-a255-54ba596febe2 a limited number of rooms are available for 4th and 5th september 2018 at £115.00 per room per night b&b for single occupancy. to book please click on the special weblink below: book your group rate for mhra cut-off date for bookings is 7th august 2018. 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: 0161 774 3172 - to book please call this number and speak to reservations. web: https://www.jurysinns.com/hotels/leeds rooms are available for 4th and 5th september 2018 at £93.00 per room per night b&b for single occupancy and £103.00 per room per night b&b for double occupancy. to book call the number above and quote ‘ mhra04091800’ . cut-off date for bookings is 7th august. if you wish to book after this date, this will be subject to availability. 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: http://www.hiexleeds.co.uk/ rooms are available for 4th and 5th september 2018 at £99.00 inc vat per room per night and includes an express start breakfast. to book call the number above and quote ‘mhr’ or alternatively, email the booking through to [email protected] cut-off date for bookings is 7th august 2018. 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: https://www.travelodge.co.uk/hotels/144/leeds-central-hotel rates from £57.00 per night, please contact hotel directly for availability and confirmation of rates. hotel ibis leeds centre 2 the gateway north, crown point road, leeds, ls9 8bz tel: 0113 245 0725 web: http://www.ibis.com/gb/hotel-6002-ibis-budget-leeds-centre/index.shtml rates from £48.00 per night, please contact hot

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