On 03 and 04 May 2018, the MHRA GPvP Inspectorate held their symposium at the Novotel Hammersmith, London. The event provided a platform for information sharing and discussion between inspectors and assessors from the MHRA and industry colleagues working within pharmacovigilance and associated departments.
The event was well attended with a collective audience of greater than 500 delegates over the two days. Although, mostly an industry aimed event, the audience also included attendees from US Food and drug Administration (FDA), European Medicines Agency (EMA), Irish Health Products Regulatory Agency (HPRA), Italian Agenzia Italiana del Farmaco (AIFA) as well as internal MHRA colleagues from the Licensing division, Information Processing Unit (IPU), Vigilance and Risk Management of Medicines division (VRMM) and other parts of the inspectorate.
What was covered?
A variety of hot topics were covered, which included inspection findings and trends, the changing face of pharmacovigilance inspections, a Brexit update, outsourcing of pharmacovigilance activities, signal detection in Eudravigilance, post-authorisation safety studies (PASS) and additional risk minimisation measures specifically focussing on educational materials.
Technical subjects focused on typical inspection scope, inspector expectations, case studies and example findings. The educational materials talk also included advice from Shahin Kauser, MHRA Lead Scientific Assessor, on the preparation and submission of educational materials, and the different types of effectiveness evaluation measures. In addition, Phil Tregunno (Interim group Manager, Vigilance, Intelligence and Research Group (VIRG), MHRA) was available to answer any questions during an interactive session on signal detection in Eudravigilance.
Changing face of Inspections
Joanna Harper, Expert GPvP Inspector and Mandeep Rai, GPvP Inspectorate Operations Manager started the day by presenting on changes underway within the GPvP inspectorate. In recent years, GPvP inspections have increased in length and complexity, as result the GPvP inspectorate now performs more frequent inspections of complex systems, where the system is partitioned into manageable chunks that can be reviewed over a series of inspections. Also, there’s been a move to incorporating office-based inspection components into most inspections to make best use of available resource and technology. In addition, work to set-up a programme of standalone office-based inspections is underway.
Additional Risk minimisation measures (ARMMs) – Educational Materials
Claire Longman, GPvP Inspector and Shahin Kauser, Lead Scientific Assessor, presented an inspectors and assessors perspective on the preparation, submission and evaluation of educational material.
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dvice was provided on what should and should not be included in educational materials and how and when the materials should be submitted to the MHRA for approval. Associated inspection findings were also presented which described common areas of deficiency identified during inspection.
Service Providers and Outsourcing
Anna Adams, GPvP Inspector, used a real-life example of outsourcing her dog care to demonstrate some of the considerations organisations should keep in mind when outsourcing pharmacovigilance activities to service providers. Anna talked about assessing the suitability of service providers, as well as mechanisms for oversight of outsourced activities, and considerations for ensuring the security and availability of data and records. The discussion concluded with example case studies of linked deficiencies identified on inspection
Post-authorisation Safety Studies
Senior GPvP Inspector, Kiernan Trevett, provided a comprehensive overview of PASS, both interventional and non-interventional. The talk started with a summary of PASS activity within the EU, including the number of PASS being undertaken. The presentation then focused on likely scope when reviewing this topic on inspection, which included the production of study listings, processes for identifying PASS within an organisation, assessing compliance with the study protocol, reporting of safety data and submission of study results.
Signal Management in EudraVigilance
The last topic of the day was an interactive session led by Rory Littlebury, GPvP Inspector and Phil Tregunno, Interim Group Manager, Vigilance, Intelligence and Research Group (VIRG). Audience members were invited to submit questions to Rory and Phil before the symposium and were also able to ask questions during the session. Rory presented on MHRA expectations relating to signal management using EudraVigilance and the likely questions inspectors might ask.
Vlogs
Pre-recorded videos (Vlogs) were available for delegates to view during the breaks. The first video was recorded by a patient advocate, Emma Friedman, which highlighted the importance of the patient voice in pharmacovigilance and ensuring that patients were able to make informed choices when deciding to take medicines. The second vlog was by recorded by Sophie Radicke, GPvP Inspector, setting out the purpose and expectations of the Pharmacovigilance System Master File (PSMF).
Interactions with the inspectorate
Throughout the two days, delegates had the opportunity to ask the presenters questions during panel sessions and at inspector’s surgeries held during the break; both of these options proved to be very popular with high volumes of questions being received. A GCP inspector was also available during the inspector’s surgeries to answer any questions relating to interventional clinical trials.
The GPvP Inspectorate will be reviewing all the questions submitted and answered during the event to identify trends and ideas for future blogs. Any blog topic suggestions can also be submitted to gpvpinspectors@mhra.gov.uk
Finally, thank you to all those who attended the symposium this year. Your attendance and interaction were much appreciated – without your support and interest these events wouldn’t be possible, we hope to see you again next time.
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