Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

July/August 2022  |  Vol. 19  |  No.7

EDITORIAL

A new era of digital and data-driven innovation

Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working. Investment and attention to this area and embracing it as part of a company’s quality culture is crucial, especially given the speed of technological advancement.

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By Kazia Nowok and Patricia Hurley

FOCUS

Translating digitalisation trends into tangiable solutions

Pharmaceutical companies are seeking to take advantage of digital innovations to become data-driven organisations, but firstly, they must overcome various data challenges to move from concept to execution. This article explores the path to successful research and development (R&D) digitalisation.

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By Timm Pauli and Torsten Osthus

FOCUS

Digital and data-driven: information management at the EMA

Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for the agency’s information management legislation.

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By Kasia Nowok

FOCUS

Data governance as a strategic imperitive for regulatory compliance

In the pharmaceutical industry, data integrity plays a vital role in decision-making during development and in maintaining the quality of products once they are in the marketplace. This article discusses the various good practices that are required by industry in relation to data integrity and quality.

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By Nancy-Pire Smerkanich

STANDALONE

Antibiotics in biopharmaceutical production

As per the WHO, antimicrobial resistance (AMR) is a global health threat and a complex problem that requires a united multisectoral approach. Using plasmid DNA (a fundamental raw material in the biotech industry) as an example, this article will focus on the ways in which regulators are increasingly discouraging the utility of antibiotics, such as through imposing control in its utility in biopharmaceutical production through tighter regulations.

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By Satish Muchakayala and Jill Makin

STANDALONE

Part 1: EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome?

Rx to OTC switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or shop without a prescription. This research investigated the challenges faced by the pharmaceutical industry with this process in the European Union and proposes where improvements could be made.

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By Sarah Landra

STANDALONE

One year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products

Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination. In this article, UCB discuss the most important aspects to consider when submitting an MAA under Article 117.

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By Giovanna Campana