Guests: Romain Clément and Olivier Merle from ArcaScience
Benefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectations from regulators andLeadership is challenging traditional approaches that rely heavily on manual review and retrospective analysis.
In this new episode, we explore how AI is reshaping benefit–risk decision-making and what this means for senior safety professionals today.
Together with experts from ArcaScience, we discuss:
What AI actually changes in day-to-day benefit–risk work
How integrated data supports earlier and more confidentdecisions
How ArcaScience models support benefit–risk acrossdevelopment stages
How regulators are reacting to AI-supported approaches
This conversation focuses on practical realities and on how safety teams can use AI to strengthen expertise, not replace it.
Follow The Pharmacovigilance Podcast on Spotify to stay updated on new episodes covering AI, safety leadership, regulatory thinking, and the future of pharmacovigilance.
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