Good Pharmacovigilance Practice (GPvP) Symposium 2024

Wednesday, 28 February 2024

Novotel London West / Virtual

About

The 2024 MHRA Good Pharmacovigilance Practice (GPvP) symposium will provide a deep dive into GPvP inspection non-compliance, metrics and trends, regulatory updates, and an opportunity to hear about the MHRA’s perspective on hot topics in pharmacovigilance.

GPvP inspectors will be available to respond to questions from attendees in panel sessions and during inspectors’ surgeries.

Participants of the GPvP Symposium will develop a deeper understanding of:

• GPvP requirements and good practice in the UK
• Latest trends in pharmacovigilance non-compliance identified during MHRA inspections
• UK regulatory updates and changes
• Regulator perspectives on hot topics in pharmacovigilance.

The symposium will be delivered in a hybrid format. Content will be made available to all registered delegates as recordings after the symposium for up to one month, allowing access at the most convenient time for you. This may be of particular interest where time zones make it difficult to watch the event in real time. 


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.

Agenda

Please note programme and timings are subject to change.

GPvP Agenda

28 February 2024, 09:00 - 17:00 GMT

Registration

Opening remarks

James Pound — Deputy Director, Standards & Compliance, MHRA

Keynote address

Mercy Jeyasingham MBE — Non Executive Director and Chair Patient Safety and Engagement Committee, MHRA

Compliance Team & MHRA Strategy update

Gain insight into the MHRA’s future direction. Learn about ongoing strategic initiatives within the Compliance Teams and the wider MHRA.

Get to know the GPvP Compliance Team.

Sophie Radicke — Head of GPvP and Senior GPvP Inspector, MHRA

Steve Vinter — Head of Compliance Team 1, MHRA

Mick Foy — Director of Delivery, MHRA

MHRA GPvP Inspection Metrics

An overview of the latest GPvP metrics for 2022/23, the types of inspections conducted, findings reported and inspection trends.

Understand and learn about common deficiencies from the aRMM and NI-PASS inspection arms since their introduction.

Sophie Radicke — Head of GPvP and Senior GPvP Inspector, MHRA

Anastasia Daskajiannis St John — GPvP Inspector, MHRA

Break & inspectors' surgery

Remote Compliance Assessment pilot

Hear about a new GPvP approach piloted in 2023 for the reinspection of critical findings. Learn about the conduct and the outcomes of the pilot. 

Zoe Hamill — GPvP Inspector, MHRA

Anastasia Daskajiannis St John — GPvP Inspector, MHRA

Non-Interventional Post Authorisation Safety Studies (NI-PASS): Assessor’s perspective

This session brings together insights, best practices and experience from the MHRA on the topic of non-interventional post-authorisation safety studies (NI-PASS).

Shahin Kauser — Assessor, Benefit/Risk Evaluation Team II, MHRA

Panel session / Q&A

Lunch & inspectors' surgery

Artificial intelligence in PV: a regulatory perspective

The drive to explore and harness Artificial Intelligence in PV is accelerating rapidly.

This unique, live panel will inform and educate the audience on the direction of travel of global AI use and regulation within PV.

Hear from representatives from the CIOMS and PIC/S AI working groups as well as MHRA experts on the implementation and regulation of AI. 

Moderator:  Steve Vinter, Head of Compliance Team 1, MHRA

Benny Ling — Senior Scientific Evaluator, Marketed Pharmaceuticals Bureau, Health Canada

Russell Pearson — AI Regulation and Policy Specialist, Innovative Devices, MHRA

Sarah Vaughan — Head of Vigilance Operations, MHRA

Sophie Radicke — Head of GPvP and Senior GPvP Inspector, MHRA

Inspection case study

Inspectors will take the audience on a deep dive of selected major and critical inspection findings covering a range of technical pharmacovigilance topics to draw attention to these issues and clarify regulatory requirements and expectations.

This case study focuses on the MAH – service provider relationship.

Silvia Danesi — GPvP Inspector, MHRA

Break & inspectors' surgery

Regulatory updates from the MHRA

Hear about the latest regulatory updates, including Windsor Framework, International Recognition Procedure (IRP), and Point of Care, and how this impacts industry and inspections.

Claire Longman — Expert GPvP Inspector, MHRA

Dr Steph Millican — Head of Immunology, Biocompatibility and Non-Clinical, Benefit/Risk Evaluation Team I, MHRA

Inspection case study

Inspectors will take the audience on a deep dive of selected major and critical inspection findings covering a range of technical pharmacovigilance topics to draw attention to these issues and clarify regulatory requirements and expectations.

This case study focuses on key requirements that MAHs of generics products need to be aware of.

Zoe Hamill — GPvP Inspector, MHRA

Panel session / Q&A

Closing remarks

Steve Vinter — Head of Compliance Team 1, MHRA

End of event

Speakers

Venue

Accommodation

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Registration

1 Day Virtual Ticket - 28 February 2024

£ 295 +VAT

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