120-124 King Street
Tel: 0871 902 1621
This years' MHRA Laboratories Symposium, will highlight the importance of 'fit for intended use' in the context of regulated work across GLP, GCP and GMPQC Laboratories. The content of the event is intended to illustrate that this topic is not just limited to facilities and equipment but can be applied across an organisation, from people and training, to quality management systems and report production. The day will include presentations from Laboratory inspectors, example findings and expectations relating to laboratory practice. The symposium will be an opportunity to meet with Inspectors and pose questions, as well as engage in interactive sessions, compelling audience participation. Our objective is for delegates to have a better understanding of the Laboratory inspectors position on the topic of 'fit for intended use', and how this can be applied in day to day regulated work.
The symposium will provide the latest information and guidance from the Laboratory inspectors.
• Keep up to date with laboratory regulatory requirements and MHRA expectations
• Opportunities to discuss current hot topics, increasing awareness of areas of compliance that monitoring authorities are likely to focus on during regulatory inspections
• Improve ability to recognise the types of compliance issue that facilities have to deal with on a day to day basis
• Opportunity – To meet the experts in the field and pose questions to the panel
The Laboratories Symposium is part of a week-long series of events led by the MHRA Inspectorate. Interested in attending more than one symposium? Details of discounted combined tickets are listed in the registration section via the Register link above.
The 2020 GPvP Symposium will provide an insight into the key topics and compliance trends in pharmacovigilance observed by the MHRA GPvP inspectors since the 2018 Symposium. The event is relevant to anyone working in pharmacovigilance, medical information and regulatory affairs, including EU QPPVs and service providers.
This symposium is in partnership with the US Food and Drug Administration (FDA) and is primarily focused at commercial organisations. The aim is to provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials, and the challenges in ensuring data quality in novel clinical trial designs.
Once you have registered, you will 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.
To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.
Please note the agendas are subject to change.
Speakers to be announced in due course.
The experience has helped me put together my own personal understanding of the MHRA and how it relates to my laboratory.
The 2019 role play sessions were extremely effective in conveying MHRA and laboratory input into inspection findings and resolution.
The Inspectors surgeries are always brilliant to get input into my specific query.
Practical applications of data integrity in the laboratory.
Clarity on the inspectorates opinion of various topics is very useful.
The rapid response to questions from senior inspectors was very useful.
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