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Artificial intelligence articles

The compounding pharmaceutical data gap: The impact of structural under-representation on AI-augmented pharmacovigilance systems

2026-10-07T08:48:00+01:00By Trina Das

This article traces the mechanism by which structural bias enters the product lifecycle and provides recommendations for marketing authorisation holders seeking to address inherited bias in deployed pharmacovigilance AI

Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives

By Dakshatha M, Shivanand K Mutta, Venugopal N and Sateesha SB
Prescribing efficiency: Using generative artificial intelligence for pharmacovigilance

By Ihab Mansoor and Matthew Rector
The role of artificial intelligence in regulatory affairs

By Rudy Fuentes, Sean Schofield and Lubomir Zahariev

FDA consults on the regulation of GenAI-enabled medical devices
2026-08-29T15:12:00+01:00By Sarah Milner
European Commission targets high-risk AI with new draft guidelines
2026-06-25T15:03:00+01:00By James Smith
The HMA-EMA NDSG publishes report on AI in medicines development
2026-06-19T14:27:00+01:00By James Smith
MHRA releases AI Airlock Phase 2 programme report
2026-06-18T15:26:00+01:00By James Smith
The National Commission into the Regulation of AI in Healthcare releases survey findings
2026-06-16T15:12:00+01:00By James Smith
Regulatory Rapporteur June 2026 – Contents
2026-06-12T10:40:00+01:00

Enhancing post-market surveillance with Artificial Intelligence and predictive analytics
2026-06-09T08:30:00+01:00By Harish Gyanaji and Murali Krishna Tirunagari
Considerations in building and maintaining regulatory intelligence
2026-06-02T09:33:00+01:00By Katy Thompson, Bridget Wiseman and Nadine O’Hare
From gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
2026-06-02T09:15:00+01:00By Attrayee Chakraborty and Geethapriya (Priya) Setty
Emergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
2026-04-09T14:10:00+01:00By Lavanya Rajamanickam and Shivanand K Mutta
The strategic role of Regulatory Operations in digital transformation success
2026-04-09T12:18:00+01:00By Sarah Chan, Christine Grew, Peter Lange, Danielle McVey, Tapasya Bhardwaj, Keira Ledger and Jacci Squire
TOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
2026-03-05T17:11:00+00:00By Victoria Goff

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