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.

 

Tickets to attend the full day event are now sold out.

Join us on the livestream for access to the full morning programme and the chance to participate in the morning panel session. Register today.

 

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

Paula Walker — Inspectorate Unit Manager, Medicines & Healthcare products Regulatory Agency

Keynote address

Dr June Raine — Interim Chief Executive, Medicines & Healthcare products Regulatory Agency

MHRA GPvP Inspection Metrics, Trends and 'Hot Topics'

Mandeep Rai — GPvP Inspectorate Operations Manager & Senior GCP Inspector, Medicines & Healthcare products Regulatory Agency

Close-up on Critical Findings and CAPA Management

Dr Anna Adams — Senior Pharmacovigilance Inspector, Medicines & Healthcare products Regulatory Agency

Sophie Radicke — Pharmacovigilance Inspector, Medicines & Healthcare products Regulatory Agency

Rory Littlebury — Senior Pharmacovigilance Inspector, Medicines & Healthcare products Regulatory Agency

Refreshments and Networking

Forward Look: the Future of Pharmacovigilance Inspections in the UK

Kiernan Trevett — Expert Pharmacovigilance Inspector, Medicines & Healthcare products Regulatory Agency

US FDA Post-Marketing Safety Compliance Metrics

Namita Kothary — Consumer Safety Officer, FDA

MHRA and US FDA: Common Cross-Agency Challenges

Mihaela Jason — Pharmacovigilance Compliance Team Leader, FDA

Kiernan Trevett — Expert Pharmacovigilance Inspector, Medicines & Healthcare products Regulatory Agency

Panel Session

Paula Walker — Inspectorate Unit Manager, Medicines & Healthcare products Regulatory Agency

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

  • Dr Anna Adams – Senior Pharmacovigilance Inspector, MHRA
  • Sarah Gomersal – Pharmacovigilance Inspector, MHRA

 

Signal Detection 

  • Elizabeth Webb – GPvP Inspector, MHRA
  • Rory Littlebury – Senior Pharmacovigilance Inspector, MHRA

 

Post-Authorisation Safety Studies

  • Kiernan Trevett – Expert Pharmacovigilance Inspector, MHRA

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

  • Dr Anna Adams – Senior Pharmacovigilance Inspector, MHRA
  • Sarah Gomersal – Pharmacovigilance Inspector, MHRA

 

Signal Detection 

  • Elizabeth Webb – GPvP Inspector, MHRA
  • Rory Littlebury – Senior Pharmacovigilance Inspector, MHRA

 

Additional Risk Management

  • Sophie Radicke – Pharmacovigilance Inspector, MHRA

Panel Session

Mandeep Rai — GPvP Inspectorate Operations Manager & Senior GCP Inspector, Medicines & Healthcare products Regulatory Agency

Closing Address

Mandeep Rai — GPvP Inspectorate Operations Manager & Senior GCP Inspector, Medicines & Healthcare products Regulatory Agency

Inspector Surgeries

Register

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GPvP half day livestreaming

£ 100 +VAT

Speakers

Accommodation

Venue

London

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