Risk-based MHRA inspections and a possible end in sight for standalone signal detection in Eudravigilance…

Takeaways from the PV & Risk Management Strategies meeting

Another PVRMS has passed, and with it, plenty of meetings with friends and colleagues. All fun aside, this year included many lively discussions of the state of pharmacovigilance. We have highlighted a few topics below, though there were many more that we would be happy to discuss.

Risk-Based MHRA inspections target Additional Risk Minimization Measures

MHRA is becoming more judicious with in planning PV inspections: moving forward, MHRA’s inspections will prioritize companies with the highest risk. According to their recent publication, available here: https://journals.sagepub.com/doi/full/10.1177/2042098619875317 MHRA will focus inspections on large organizations, organizations recently merged or acquired and products with additional PV and RMM commitments.

An end to paper label inserts in Japan

PMDA plans to do away with all paper drug labels by summer 2021– the Japanese regulator will likely come up with a solution similar to Taiwan’s mobile app for patients to access label information.

To those of us who are not directly impacted by the new guidance, this is a timely reminder that patient and provider engagement will continue to shift digital in the coming years.

The seismic shifts of Brexit in drug safety

With the 31 Jan deadline for Brexit looming, this topic was on everybody’s mind throughout the meeting. Indeed, Brexit has had a massive impact in the European drug safety landscape among regulators and industry alike. Brexit has been a distraction in the scope of patient safety and caused turmoil in the personal lives of UK-based QPPV’s and EMA personnel, who have had to either relocate or find new employment.

Industry works toward upstream solutions to low-value data work

Vicki Edwards, AbbVie QPPV, presented industry perspectives from 2019 on efforts to revise two processes required by regulatory guidance that have proven to have shockingly low value. A recent survey conducted showed that of 32 companies surveyed, not a single new risk has been identified from over 140K signals detected during standalone signal detection in Eudravigilance’s Pilot. Additionally, though Patient Support Programs are famous for generating massive quantities of ICSRs, the data has yielded very few safety signals. Edwards’ talk was a fascinating look into the effectiveness of regulatory guidance as well as the work that Industry puts into contributing to EMA and ICH regulations.

If you didn’t get a chance to meet with the Orbit team at the PV Strategies meeting, email orbit@feith.com or fill out the form located in this blog post.