All Journal articles – Page 4

  • Med-Devices
    Journal

    Medical device standards update: November 2023

    2023-11-03T00:05:00Z

    This edition of our regular column updates the progress of applicable standards to October 2023.

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    Journal

    Transitioning from paper to electronic IFU for EU MDR 2017/745

    2023-11-03T00:05:00Z

    The European Union Medical Device Regulation (EU MDR) Regulation (EU) 2017/745[1] amends current the EU Medical Device Directive (MDD) ‘93/42/EEC’ and the EU Active Implantable Medical Device (AIMD) ‘90/385/EEC’ directives. The regulation governs the manufacturing and supply of medical devices in the European Region and its territories. Several significant changes ...

  • Interview
    Journal

    A harmonised approach to clinical data standards

    2023-11-02T00:05:00Z

    David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.  

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    Journal

    November 2023 – Contents

    November 2023  |  Volume  20  |  No.10

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    Journal

    Prequalification of veterinary vaccines and medicines

    2023-10-02T15:30:00Z

    An initiative to assure the quality of veterinary medicinal products for use in animal health programmes to support humanitarian assistance.

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    Journal

    Transition to the new QRD template for veterinary medicines: challenges and opportunities

    2023-10-02T15:30:00Z

    The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...

  • MedDevMat
    Journal

    Optimal materials selection in medical device development – a proactive biocompatibility approach

    2023-10-02T15:30:00Z

    Regulatory Rapporteur October 2023 | Volume 20 | No.9 Introduction Biocompatibility evaluation of medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the ...

  • Dog receiving flea treatment
    Journal

    EMA activities related to antiparasitic veterinary medicinal products

    2023-10-02T15:30:00Z

    Antiparasitic medicines rightly play an important role in veterinary medicine, as antiparasitic diseases can have important impacts on animal health and welfare and are economically significant. Antiparasitic veterinary medicinal products (VMPs) are evaluated under the same thorough licensing procedure as all other veterinary medicines before they are authorised, and are ...

  • RR-Oct-2023-Cover
    Journal

    October 2023 – Contents

    October 2023 | Volume 20 | No.9

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    Journal

    Autogenous vaccines under Regulation (EU) 2019/6

    2023-10-02T15:30:00Z

    Through Regulation (EU) 2019/6, it has been the first time that so-called autogenous vaccines (AVs) are included in the EU legislation that rules veterinary medicinal products. Described as inactivated vaccines which are manufactured from pathogens obtained from animals in an epidemiological unit, they are restricted to the ...

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  • Supply-Chain-Medicines
    Journal

    Q&A:
    Navigating the
    pharmaceutical supply chain

    2023-09-01T13:30:00Z

    Matthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member

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    Journal

    Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry

    2023-09-01T13:29:00Z

    Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...

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    Journal

    Navigating the global supply of starting materials for cell-based therapies

    2023-09-01T00:05:00Z

    The use of biological starting materials in the development of allogeneic cell-based therapies poses several challenges, whether due to availability of appropriate donors, complicated global logistics, or lack of global regulatory harmonisation around technical testing requirements. Sponsors must pay attention to adventitious agent safety requirements, which vary from region to region, and can also be affected by emerging disease threats, as was the case with the recent COVID-19 pandemic. Dr Elena Meurer, principal consultant and director at Biopharma Excellence, and Dr Jennifer Sales, consultant at Biopharma Excellence, explore these complexities.

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    Journal

    Biosimilars CMC development considerations from the sponsor perspective

    2023-09-01T00:05:00Z

    Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.

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    Journal

    Warning letters for direct-to-consumer advertising: a five-year retrospective analysis

    2023-09-01T00:05:00Z

    Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...

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  • RR-Sept-2023-Cover
    Journal

    September 2023 – Contents

    September 2023 | Volume 20 | No.8

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  • Human tissue
    Journal

    EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products

    2023-08-03T15:00:00Z

    After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and ...