Regulatory
Rapporteur

 

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March 2025  |  Vol. 22  |  No. 3

EDITORIAL

Data and AI: Readiness, research and real-world impact

The March issue of Regulatory Rapporteur focuses on data and artificial intelligence. Effective management of regulatory data has always played a critical role in maintaining compliance and accelerating product development. We are now in a period of significant evolution and growth in this space, with artificial intelligence (AI) and large language tools becoming increasingly available in the public domain. In this issue, we explore how data quality can enhance regulatory intelligence and improve performance, and discuss how ready regulatory organisations are to adopt AI, and its potential use in post-market surveillance.

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By Victoria Goff

FOCUS

Organising high quality research and development data for success

This article looks at the challenge of ensuring high quality data in regulatory information management (RIM) systems and suggests that moving from managing data in research and development (R&D) silos to a more cross-R&D operating model could improve data quality and maximise efficiency.

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By John Cogan of JPC Advisory Limited

FOCUS

AI adoption readiness: Current status and trends in regulatory organisations

While there is no doubt that AI will add significant value to global regulatory practices over time, it is still unclear when organisations will be ready to integrate it to a trusted level. This article summarises the key findings of a survey that explores advanced technology status and investment priorities within the regulatory function for both pharmaceutical and medical device companies and discusses the importance of data management and governance programmes in this implementation process.

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By Steve Gens of Gens & Associates

FOCUS

Artificial intelligence and post-market surveillance

While tools like ChatGPT may create an impression of AI being easy to use, wide AI applications are prone to hallucinations and therefore can be dangerous in the context of post-market surveillance (PMS). This article discusses the benefits for medical device PMS but also the challenges that must be overcome, using practical examples of AI-generated text to illustrate potential issues.

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By Mika Reinikainen of Abnovo Limited

FOCUS

Using data to drive regulatory performance

The art of regulatory intelligence has advanced significantly over the past few years, but the effective use of analytics is lagging, with survey research showing that only 55% of responding companies consider their regulatory metrics programmes to be effective. This article compares traditional knowledge management approaches with tools such as AI/machine learning (ML) and regulatory analytics and the advantages that these can bring.

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By Patterson Shafer of FTI Consulting

STANDALONE

Immunological considerations in the development of novel vaccines

Part 2: Immune correlates of protection, immunobridging, clinical effectiveness trials and the impact of population diversity 

The second article in this series looks at how understanding the immune response supports prediction of vaccine effectiveness and can optimise clinical development of vaccines, and the impact of population diversity on vaccine response.

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By Cecil Nick of Parexel International

STANDALONE

The EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams

The EU’s Health Technology Assessment Regulation (EU-HTAR) demonstrates a significant transformation in how health technologies are evaluated across EU member states and aims to streamline evidence generation planning through early and defined collaboration between the European Medicines Agency and Health Technology Assessment bodies. This article discusses considerations for regulatory teams.

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By Rosa Willock, Sophia McGovern and Michael Harding of Decisive Consulting Limited and Tom Oakley of Somerville Development Partners