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.

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.