Tuesday 11 February 2020, Novotel London West

Good Pharmacovigilance Practice Symposium 2020

About

The 2020 Good Pharmacovigilance Practice (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.

In the morning programme, we will discuss current challenges in pharmacovigilance faced by industry, including Brexit, and will present the latest MHRA inspection metrics. The afternoon’s programme will focus on technical topics in the form of smaller seminars and round table sessions. These seminars will provide those working in pharmacovigilance with an opportunity to discuss common inspection findings and case studies in these areas with inspectors and subject matter experts from the MHRA.

During the event there will be multiple opportunities to speak to inspectors, including the inspectors’ surgeries where you can discuss specific questions you may have, formal panel sessions, and more informally as inspectors circulate during the event. Information will also be provided during the event via video cards and informal pop-up sessions.

New for 2020, this year, we are going to make this popular event more accessible by livestreaming the morning programme. This new interactive element will provide those unable to attend in person a unique opportunity to gain access to key presentations. When registering for this event you will have the option of attending in person or to sign up to watch the morning sessions through the livestream. For all who register to livestream, content from the morning programme will be made available as recordings after the event, allowing access at the most convenient time for you.

 

MHRA Good Practice Symposia Week

The GPvP 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.


MHRA Laboratories Symposium (Labs)

The 2020 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.

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Good Clinical 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.

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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 - #MHRAGPvP20

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MHRA GPvP

Agenda

Please note agenda timings are subject to change.

11 February — full schedule

11 February 2020, 08:30 - 17:00

Registration and Refreshments

Opening address

Update on EU exit and impact on pharmacovigilance for UK authorised products

Forward look: the future of pharmacovigilance inspections in the UK

Refreshments and Networking

MHRA GPvP inspection metrics, trends and "hot topics"

US FDA Post-marketing safety compliance metrics

MHRA and US FDA: Common cross-agency challenges

Panel Session

End of Livestream

Lunch, Networking and Inspector Surgeries

Seminar session one

Please note, these seminars are run in parallel. At the time of booking you will be asked to select one seminar from session 1 and one seminar from session 2.

- Reference Safety Information

- Signal Detection 

- Post-Authorisation Safety Studies

Refreshments and Networking

Seminar session two

Please note, these seminars are run in parallel. At the time of booking you will be asked to select one seminar from session 1 and one seminar from session 2.

- Reference Safety Information

- Signal Detection 

- Additional Risk Management

Panel Session

Closing Address

Register

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GPvP one day ticket

£ 590 +VAT

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GPvP half day livestreaming

£ 250 +VAT

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GPvP 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.