GOOD PHARMACOVIGILANCE PRACTICE SYMPOSIUM

Thursday 10 - Friday 11 March 2022

About

The 2022 Virtual Good Pharmacovigilance (GPvP) Symposium will provide an insight into the key topics and compliance trends in pharmacovigilance observed by the Medicines and Healthcare products Regulatory Agency (MHRA) GPvP inspectors since the 2020 Symposium.

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.

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.


CPD credits: 7.25 credits available for full attendance 10-11 March 2022, please note individuals should only record the number of hours they attend.

 

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 Clinical Practice Symposium held in partnership with the 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.

Click through for further information on this year’s event including ticket options

 


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 - #MHRAGPvP22

Agenda

Please note programme and timings are subject to change.

GPvP - Day 1

10 March 2022, 12:00 - 16:45 GMT

Opening plenary session

Paula Walker — Head of Compliance (1), GCP, GPvP & GLP, MHRA

Keynote speech

Dr Alison Cave — Chief Safety Officer, MHRA

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

As the world adjusted to the COVID-19 pandemic, regulatory oversight had to adapt too. Theses presentations will review how the MHRA and US FDA pharmacovigilance inspection programmes evolved during the pandemic and will discuss how these changes will influence the future of the programmes.

 

Mandy Budwal-Jagait — Head of GPvP, MHRA

Sherry Bous — Director of the Division of Enforcement and Postmarketing Safety, FDA

MHRA GPvP inspection metrics, trends and developments

An overview of the latest GPvP metrics for 2020/21, the types of inspections conducted, findings reported and inspection trends. The latest developments to the GPvP inspection model will also be presented, providing an insight into the risk-based methodology used to determine the scope of inspections.

 

Sarah Gomersal — Pharmacovigilance Inspector, MHRA

Pop-UP: Innovative Licensing Access Pathway (ILAP) - A streamlined approach to regulation and patient access

Dr Dan O’Connor — Expert Medical Assessor, MHRA

Break

Quality of safety variations and guidance on reference product information alignment

Keeping the product information updated with current scientific knowledge is an important measure to ensure the safe use of medicines by patients and prescribers. In this presentation, MHRA assessors will provide guidance for products that require alignment with their originator product and share top tips on how marketing authorisation holders can contribute to the timely approval of safety variations. 

 

Shazia Khalid — Scientific Assessor, MHRA

Dr Valentine Ibekwe — Pharmaceutical Assessor, MHRA

GPvP inspection case studies

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:

  • Case study 1 will illustrate significant findings relating to failures in fundamental pharmacovigilance requirements and will provide some practical advice for companies to ensure that they are in compliance.
  • Case study 2 will focus on a case of missing source documentation affecting several marketing authorisation holders involved in a chain of divestments to emphasise the importance of due diligence activities during mergers and acquisitions.

 

Claire Longman — Pharmacovigilance Inspector, MHRA

Sophie Radicke — Pharmacovigilance Inspector, MHRA

Pop-up: Quality of pregnancy-related ICSR

Sophie Reeve — Therapeutic Group Coordinator, MHRA

Kate Madden-Raja — Scientific Assessor, MHRA

Break

Panel session

Chaired by Mandy Budwal-Jagait

Day 1 closing remarks

Kiernan Trevett — Expert Pharmacovigilance Inspector, MHRA

GPvP - Day 2

11 March 2022, 12:00 - 16:50 GMT

Day 2 opening remarks

Mandy Budwal-Jagait — Head of GPvP, MHRA

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

The UK left the EU on 31 January 2020 and the transition period ended on 31 December 2020. Initially the UK remains very highly aligned with the EU regulatory framework, free to take independent decisions in relation to Great Britain whilst remaining aligned with EU decisions in respect of Northern Ireland. This presentation will provide an update on where we are now in relation to pharmacovigilance now that the UK has left the EU.

 

Kiernan Trevett — Expert Pharmacovigilance Inspector, MHRA

Dr Stephanie Millican — Benefit-Risk Unit Manager, MHRA

GPvP inspection case studies

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:

  • Case study 3 will explore a critical finding from a non-interventional PASS inspection to discuss what should be considered a true intervention in a non-interventional study and highlight the importance of adherence to the study protocol to ensure data integrity.
  • Case study 4 will examine the basis for a critical finding reported due to the failure to evaluate product safety concerns. A background to the inspection will be provided, along with a closer look at the deficiencies identified and the corrective and preventative actions. 

 

Mandy Budwal-Jagait — Head of GPvP, MHRA

Sarah Gomersal — Pharmacovigilance Inspector, MHRA

Pop-Up: Medicines Information Systems

Dr Katherine Donegan — Pharmacoepidemiology Research & Intelligence Unit Manager, MHRA

Break

Pop-Up: Yellow Card – Changing how incident information is processed

Mick Foy — Deputy Director, Patient Safety Monitoring, MHRA

Pop up: Use of AI in pharmacovigilance case processing

Phil Tregunno — Group Manager – VRMM, MHRA

Overview of the ARMM/REMs Inspection programmes in the UK and US

Hear about the differences between the MHRA and FDA additional risk management measures inspection programmes: the type of measures included within these programmes, how inspectors collaborate with assessors regarding these programmes, what you can expect from an MHRA and FDA inspection in this area and what the common inspection findings from both Agencies are.

 

Claire Longman — Pharmacovigilance Inspector, MHRA

Dipti Kalra — Team Leader of the Risk Evaluation and Mitigation Strategies (REMS) Compliance Team, FDA

Regulatory updates

The MHRA is driving forward a new era in enabling regulation and regulatory science, to address the challenges faced by the life sciences sector and health service. This presentation will provide an update on the evolving UK medicines regulatory framework and the impact upon the GPvP inspection programme.

 

Kiernan Trevett — Expert Pharmacovigilance Inspector, MHRA

Break

Panel session

Chaired by Mandy Budwal-Jagait

GPvP Symposium closing session

Paula Walker — Head of Compliance (1), GCP, GPvP & GLP, MHRA

Speakers

Register

Registration

GPvP ticket

£ 350 +VAT

Registration

GPS Week
7-11 March 2022

£ 695 +VAT