All Regulatory Rapporteur articles in July/August 2022

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    July/August 2022 – Contents

    July/August 2022  |  Volume  19  |  No.7

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    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.

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    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. In the interest of patients and environmental safety, regulators around the globe are discouraging the use of antibiotics in all areas of their utilisation ie, not only at ...

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    Translating digitalisation trends into tangible solutions


    Pharmaceutical companies are seeking to take advantage of digital innovations to become data-driven organisations, but rstly, they must overcome various data challenges to move from concept to execution. Timm Pauli, Head of R&D Informatics at PharmaLex, and Dr. Torsten Osthus, Advisory Consultant to PharmaLex and Managing Director of Osthus Group, (whose service division, Osthus Services, recently merged with PharmaLex), explore the path to successful R&D digitalisation.

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    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. It is important for consumers to have direct access to medicines without a prescription as this allows time for doctors to focus on more urgent care needs. This emphasis on consumer “self-care” is even more important now, during a pandemic, when face-to- face consultations with doctors have reduced.

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    Data governance as a strategic imperative for regulatory compliance


    Data governance is a multi-faceted arrangement that relies on data quality, data integrity, data and document management, security and safe storage. It is critically important to companies and regulators as they evaluate product quality, the manufacturing process and the reliability of study data from non-clinical and clinical research. The integrity ...

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    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 information management legislation

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    A new era of digital and data-driven innovations


    Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working