This years Laboratories event 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, an opportunity to meet with Inspectors to ask questions and interactive sessions to get the audience involved. After the event, delegates will 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 on changing legislation and increasing complexity within the industry. 

• 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 routine 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

MHRA Good Practice Symposia Week

The Laboratories Symposium [TBC] is part of a week-long series of Inspections, Enforcement and Standards events. Interested in attending more than one symposium? Details of discounted combined ticket are listed in the registration section below. 

For more information on the other events taking place during the week please follow the relevant links.

Good Clinial Practice (GCP)

This symposium is in partnership with the US Food and Drug Administration (FDA). 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.

(Click to see details) 

Good Pharmacovigilance Practice (GPvP) 

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.

(Click to see details)

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.