Wednesday, 12 February 2020

MHRA Laboratories

About

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

 

MHRA Good Practice Symposia Week

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.


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 for details)


Good Clinical Practice (GCP)

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.

(Click for details) 

 

 


Questions For The Panel

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.

Twitter - #MHRALabs20

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MHRA Laboratories Symposium

Agenda

Please note the agendas are subject to change.

Agenda — full schedule

12 February 2020, 08:45 - 16:45

Registration and Refreshments

Opening address

Fit for Intended Use

Equipment selection/validation

Refreshments, Networking and Inspector Surgeries

Analytical Methods

Interactive Session - Training

Quality Management Systems

Lunch, Networking and Inspector Surgeries

Management of Data

Reporting

Refreshments, Networking and Inspector Surgeries

Interactive Session - Computerised Systems

Panel session

Closing Address

Register

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Labs non-commercial one day ticket

£ 305 +VAT

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Labs commercial one day ticket

£ 590 +VAT

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Labs and GCP combined ticket

£ 1330 +VAT

Speakers

Speakers to be announced in due course.

Accommodation

Venue

London

Discover the contemporary elegance of Novotel London West, located in the bustling heart of Hammersmith West London. Whether you choose our 4-star hotel for business or leisure, it's the perfect place to stay for comfort and location.

Our warm and welcoming, multi-lingual team's only goal is to make your stay with us a relaxing, enjoyable experience. With 630 spacious rooms and 33 dedicated conference, meeting and events spaces suitable for 1 to 2,000 people, no other venue in London is as well equipped or as flexible. Whatever the reason for your stay from weekend city break, family holiday or business, you can be confident that we have the perfect room or event space for you.