MHRA GPvP SYMPOSIUM

THURSDAY 10 - FRIDAY 11 MARCH 2022

VIRTUAL SYMPOSIA

About

The 2022 GPvP Symposium will provide an insight into the key topics and compliance trends in pharmacovigilance observed by MHRA GPvP inspectors since the 2020 Symposium. The event is relevant to anyone working in pharmacovigilance, medical information and regulatory affairs, including UK QPPVs and service providers.

The symposium will take place on two consecutive afternoons during which we will discuss current challenges in pharmacovigilance faced by industry, including lessons learnt following the end of the EU Exit Transition period and adaptations to inspection processes implemented by the MHRA and the U.S. Food and Drug Administration (FDA) in response to the COVID-19 pandemic. We will present the latest MHRA inspection metrics, put the spotlight on specific inspection findings in case studies, and keep you informed of regulatory updates and changes. The programme of presentations will be interspersed with short pop-up sessions covering the latest news and developments in pharmacovigilance at the MHRA.

Colleagues from the U.S. FDA will be joining us for a global view on pharmacovigilance and inspections.

A panel session will take place on each day where inspectors and subject matter experts from the MHRA will answer your questions submitted before and during the symposium.

Due to the ongoing worldwide COVID-19 pandemic, the symposium will be delivered as a livestreamed, online-only event. Content will be made available to all registered delegates as recordings after the symposium, 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.
 

MHRA Good Practice Symposia week
The Good Pharmacovigilance Symposium is part of the MHRA Good Practice Symposia week which will provide you with insight into key topics, compliance trends and the opportunity to hear first-hand from MHRA Inspectors and speakers from US Food and Drug Administration (FDA) and Health Canada. Good Practice Symposia week will also include the Good Pharmacovigilance Symposium. Good Practice Symposia week will also include the Good Clinical Practice Symposium held in partnership with the US Good and Drug Administration (FDA) and Health Canada.
 

Good Clinical Practice
Monday 7 – Wednesday 9 March 2022, 12:30-16:30 GMT

This three-day event is in partnership with US Food and Drug Administration (FDA) and Health Canada. This virtual workshop follows previous joint events between the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration’s (FDA), Center for Drug Evaluation and Research (CDER) including Workshops in October 2018: ‘Data Integrity in Global Clinical Trials- Are We There Yet?’ and February 2020: ‘Data Integrity in Global Clinical Trials Tackling Challenging Topics.’ At the March 2022 event, the MHRA and FDA welcome Health Canada (HC) to the collaboration.

Further information on this year’s event including ticket options can be accessed here.

 


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

Agenda

Please note agenda timings are subject to change.

GPvP - Day 1 — full schedule

10 March 2022, 12:00 - 16:45

Opening plenary session

Adapting to the COVID-19 pandemic: Perspectives from MHRA and FDA

Mandy Budwal-Jagait — GPvP Operations Manager and Lead Senior GCP Inspector, MHRA

MHRA GPvP inspection metrics, trends and developments

Sarah Gomersal — Pharmacovigilance Inspector, MHRA

Pop-up: Innovation Office updates

Break

Quality of safety variations and guidance on reference product information alignment

Shazia Khalid — MHRA

GPvP inspection case studies

Claire Longman — Pharmacovigilance Inspector, MHRA

Sophie Radicke — Pharmacovigilance Inspector, MHRA

Pop-up: Quality of pregnancy-related ICSR

Break

Panel session

Day 1 closing remarks

GPvP - Day 2 — full schedule

11 March 2022, 12:00 - 17:00

Day 2 opening remarks

Feedback on compliance and experience after the end of EU Exit Transition period

Kiernan Trevett — Expert Pharmacovigilance Inspector, MHRA

GPvP inspection case studies

Mandy Budwal-Jagait — GPvP Operations Manager and Lead Senior GCP Inspector, MHRA

Sarah Gomersal — Pharmacovigilance Inspector, MHRA

Pop-up: Medicines information registries

Katherine Donegan — MHRA

Break

Pop-up: SafetyConnect

Mick Foy — MHRA

Pop up: Use of AI in pharmacovigilance case processing

Dominic Nguyen-Van-Tam — MHRA

Phil Tregunno — MHRA

Approaches to managing risk in the UK and US

Claire Longman — Pharmacovigilance Inspector, MHRA

Regulatory updates

Kiernan Trevett — Expert Pharmacovigilance Inspector, MHRA

Break

Panel session

GPvP Symposium closing session

Speakers

Register

Registration

GPvP ticket

£ 350 +VAT

Registration

GPS Week
7-11 March 2022

£ 347.50 +VAT