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Verona, Copenhagen, Amsterdam, Boston… PV is all around

The significance, importance and impact of PV is quickly gaining prominence on the Global agenda. As a clear indicator of this we see a growing number of international conferences and congresses aimed at creating forums for experts within PV to discuss, interact, and share knowledge.

As a global company dedicated to drive and support the crucial development of innovative solutions for Pharmacovigilance, Insife is a frequent participant and contributor at these events. Over the last month we have attended and participated in events in Verona, Copenhagen, Amsterdam and Boston.

All four had interesting, diverse agendas and notable speakers on the program. All gave new insights and knowledge to broaden perspectives with a lot of focus on the impact of COVID-19 and how both regulators and industry managed to cope with significantly higher case volumes at short notice. One theme was consistent: The central role of AI, ML and Automation.

The Universal Relevance We can use the agenda from the World Drug Safety Congress in Amsterdam as an example. The congress ran for three days, with the most heavily packed programme the first day. And this day had quite a few sessions devoted to AI and Automation.

A panel discussion with the participation of CxO-representatives from Moderna Therapeutics, GSK, Merck, Compugen Ltd., and AstraZeneca, 12 keynotes – one delivered by Insife CEO Martin Holm-Petersen and CSMO Jen Markey – followed by 7 roundtables covering topics ranging from “Working through business cases for AI return on investment” and “How can we do better using AI? Use cases of medical literature monitoring” to “Leveraging AI and Analytics to Unlock Strategic Insights and Make Sense of Big Data” underlining the fact that AI is a need applicable to all departments and functions – from PV and regulatory affairs to the production line and applies to companies, research institutions, academia and the regulation of life sciences and health care.

The International Society of Pharmacovigilance (ISoP) annual meeting was held in Verona this year and again the overwhelming focus was on lessons learned from the COVID-19 pandemic with discussions on traditional vs. innovative approaches from both an industry and regulatory perspective. The AI track on day 2 touched on the use of AI to identify ADRs from patient reports during the vaccination programs but also looked at where we stand with using AI across the PV lifecycle and specifically for signal detection.

Similar to the WDSC in Amsterdam, the US congress held in Boston, contained a number of panel discussions, presentations and roundtables on the topic of AI. A few examples are: “Active surveillance use cases for an AI enabled screening platform”, “Navigating the changing landscape of PV safety databases”, “Unlocking free text quality & compliance data via text analytics and machine learning”, “Transformation of pharmacovigilance operations to enable oversight and proactive management of compliance, quality through automation, digital processes, metrics & risk indicators” … interestingly, almost all the AI & automation sessions were focused on operational use and only few expanded on use in other areas like signal detection and compliance where return on investment may be more significant.

Of note during WDSC in Amsterdam and again in Boston, was a presentation by the MHRA which discussed their enhanced data collection and signal detection through the use of technology and AI (which includes Insife’s HALOPV AI solution). When asked if the MHRA supports the use of AI by industry the response was that the MHRA is using AI, so they actively encourage others to use it too!

Last, but by no means least, was Nordic PhV Day held in Copenhagen. This meeting focused on the industry and regulatory perspectives relating to PV inspections and signal detection, so it was interesting to hear and discuss the differing points of view! We also received an update on data privacy and how to manage PV agreements in an ever changing regulatory landscape.

Answering the tough question

Throughout these events, Insife CEO Martin Holm-Petersen and CSMO Jen Markey presented sessions, hosted roundtable discussions, and held a poster presentation on the topic “Solving the PV Technology Puzzle in the Digital Era” focusing on how to simplify, automate and address the 4 corners of digital advancement for PV: Digital orchestration of processes, Automation / AI, Big Data, and the Cloud.

Difficult challenges to address, but essential considerations to make to future-prove the handling of PV and to stay compliant, innovative, and competitive.

To read more about HALOPV and the use of AI across the PV lifecycle go here

The presentation from WDSC in Amsterdam is available for download:

WDSC EU Presentation
Download PDF • 1.46MB


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