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Regulatory
Rapporteur

Write to the Editor at publications@topra.org

January 2022 | Vol. 19 | No.1

EDITORIAL

What does 2022 have in store for clinical trials?

Although the pandemic is not over yet, as we move forward, we must embrace these advances and not return to ‘business as usual’ despite the challenges such ways of working entail’

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By Nancy Pire-Smerkanich and Ilse-Maria Nolan

FOCUS

A regulatory lens on an industry imperative: diversity in clinical research

Although clinical research is evolving alongside new technological advances, the inclusion of diverse populations in clinical trials has been slow. This article discusses the need for improved understanding of the importance of diversity in clinical research.

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By Aman Khera and Sarah Bly

FOCUS

Clinical trial information system: overview, opportunities and challenges

The clinical trial information system (CTIS) will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications. This article reviews the CTIS structure and outlines challenges for clinical trial sponsors.

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By Guilia Detela et al.

FOCUS

Facilitating the use of information to improve global health

David Evans, President and Chief Executive Officer of the Clinical Data Interchange Standards Consortium, discusses how the organisation is moving into an era of implementing digital standards and how they can be used for automation.

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By Leah Kleylein

FOCUS

On the path to adoption of decentralised clinical trials

Decentralised clinical trials (DCT) offer great potential to improve the clinical trial paradigm, bringing more diversity and less burden to participants. This article discusses the benefits of DCTs.

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By Wendi M Lau

STANDALONE

Requirements for the good distribution practice of medicinal products

There are no standardisation frameworks to practice as a responsible person across the EU. This article discusses the current educational and work experience requirements in EU member states

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By Bettina Von Brockdorff and Lilian M Azzopardi

STANDALONE

Substance-based medical devices: regulatory challenges and prospects

The Medical Device Regulation (MDR) has introduced several extensive changes to the regulatory framework for substance-based medical devices. This article provides an overview of the most prominent changes introduced under the MDR for substance-based medical devices.

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By Oliver Hartmann