All Artificial intelligence (AI) articles
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JournalTOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
This article summarises the discussions at TOPRA’s Annual Lecture 2026, which focused on the responsible global govenance of AI in healthcare
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Industry newsMHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
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Industry newsFDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
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Journal2025 UK MDR Regulatory Conference: Meeting report
This article is a report of the 2025 UK MDR Regulatory Conference that was hosted by TOPRA and RAPS.
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JournalThe evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
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ContentsRegulatory Rapporteur January 2026 – Contents
The January issue of Regulatory Rapporteur focuses on complex products.
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EditorialNavigating complexity: Regulation at the interface of innovation, technology and confidence
This issue focuses on complex products, with articles on brain-computer interfaces, radiopharmaceuticals and sophisticated generic products, and explores how regulatory systems can remain robust and predictable while enabling novel technologies to reach patients.
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Journal2025 Regulatory Intelligence Conference Europe: Meeting report
This article summarises sessions from the TOPRA/RAPS 2025 Regulatory Intelligence Conference Europe.
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JournalIVD8: The hunt for evidence – An IVD perspective
This is a report of the IVD8 session that took place at this year’s Symposium.
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JournalIVD6: The evolution of the In Vitro Diagnostic Regulation
This is a report of the IVD6 session that took place at this year’s Symposium.
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JournalMD7: Updates on Artificial Intelligence legislation and policy
This is a report of the MD7 session that took place at this year’s Symposium.
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JournalMD5: The evolution of the EU Medical Device Regulation
This is a report of the MD5 session that took place at this year’s Symposium.
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JournalHM3: Applying Artificial Intelligence in real life
This is a report of the HM3 session that took place at this year’s Symposium.
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ContentsNovember 2025 – Contents: Medical devices/IVD sessions
The November issue of Regulatory Rapporteur reports on the medical devices/IVD sessions from the TOPRA Symposium 2025.
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ContentsNovember 2025 – Contents: Human medicines sessions
The November issue of Regulatory Rapporteur reports on the human medicines sessions from the TOPRA Symposium 2025.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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JournalHM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)
This is a report of the HM6 session that took place at this year’s Symposium.
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Industry newsNICE reviews health technology assessment to better support patients
This industry news update shares NICE’s plans to review how health technologies are evaluated.
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Industry newsAI Airlock: Growing the future of artificial intelligence technology in healthcare
This industry news update is about the ongoing projects as a part of AI Airlock led by the MHRA.
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JournalDigital transformation of global regulatory affairs: Then, now and next
This article explores GenAI and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR).