Artificial intelligence | Pharmaceuticals | Regulatory Rapporteur

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Artificial intelligence articles

Digital transformation of global regulatory affairs: Then, now and next

2025-09-05T09:10:00+01:00By Craig Anderson and Michael J Abernathy

This article explores GenAI and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR).

Sandbox of trust: Regulated AI for health promotion and disease prevention
2025-06-06T14:07:00+01:00By Catarina Carrão
Prescribing efficiency: Using generative artificial intelligence for pharmacovigilance
2025-05-02T13:42:00+01:00By Ihab Mansoor and Matthew Rector
The role of artificial intelligence in regulatory affairs
2025-01-10T08:54:00+00:00By Rudy Fuentes, Sean Schofield and Lubomir Zahariev
MD2/IVD2: Unravelling AI as a medical device - Insights into the EU AI Act and other global perspectives
2024-11-08T06:56:00+00:00By Margareth Jorvid
Breaking barriers: the future of CMC powered by AI
2024-10-11T10:24:00+01:00By Mariam Amer, Eric Kelly, George Oliarnyk and Tiejun Wang
Unveiling the synergy of AI’s regulatory harmony in shaping the future of biopharmaceutical progress
2024-04-03T12:00:00+01:00By Baily Thomas, Madison Burns, Danielle Helton Corwin and Eddie Reilly

Developing a digital people strategy to harness the power of generative AI
2024-02-09T16:30:00+00:00By Sarah Chan, Danielle McVey and of the TOPRA RegOps SPIN group
Sink or swim: the changing tides of device regulation
2024-02-08T00:05:00+00:00By Esteban Herrero-Martinez and Dejan Brkic
Chemical characterisation: a critical first step for medical device development
2024-02-08T00:05:00+00:00By Jocivania Oliveira da Silva and Marielle Fournier
Overview of medical device regulations in Canada
2024-02-08T00:05:00+00:00By Hasnaa Fatehi
AI meets medtech:
big opportunities
require a
measured approach
2024-02-08T00:05:00+00:00By Jacques du Preez
EU MDR implementation – what is changing for the medical device industry?
2024-02-08T00:05:00+00:00By Ravi Mishra, Vivek Singh Bhagoor, Dharti Shah, Pinki Mishra, Harika Potta, Vesna Sevaljevic, Branislav Radivojevic, Deepti Jagga, Scott Krygier, Vivek Tomar and Allison Gillespie

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