All Journal articles – Page 5

  • Is consulting in regulatory affairs your next career path?

    Is consulting in regulatory affairs your next career path?


    Navigating the corporate ladder isn’t always clear cut. Along the way you may move in and out of the industry, stay in one position for too long, or even jump from specialist to director. Some ditch the politics all together and become their own boss. What is it like being a consultant, contingent worker, or contractor?

  • EMA’s IDMP-SPOR Implementation Guideline v2.1.1

    EMA’s IDMP-SPOR Implementation Guideline v2.1.1


    Identification of Medicinal Products (IDMP) standards were developed by the ISO to specify the use of standardised definitions for the identification and description of medicinal products for human use. In this article, we provide an overview of the latest IDMP v2.1.1 guideline and summarise that, given the scope of changes, it is relatively low impact to the regulatory profession.

  • Environmental impact of pharmaceuticals and regulation in the EU

    Environmental impact of pharmaceuticals and regulation in the EU


    The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.

  • IMDRF: Origins, purpose and current work

    IMDRF: Origins, purpose and current work


    In a landscape of rapidly evolving technologies, the International Medical Device Regulatory Forum (IMDRF) aims to accelerate international medical device harmonisation. A summary of the work being undertaken by the IMDRF.

  • Journal

    February 2023 – Contents

    February 2023   |   Volume 20   |   No.2

  • Regulatory Rapporteur February 2023
  • Accelerated regulatory pathways: Vaccines for tropical diseases

    Accelerated regulatory pathways: Vaccines for tropical diseases


    Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.

  • Regulation versus innovation in life sciences

    Regulation versus innovation in life sciences


    With Regulations evolving to meet the needs of changing technologies, demographics and health care practices, regulatory affairs professionals must ensure that the ever-changing requirements placed upon product or manufacturers are met and where possible met at minimal costs. Within this article we look to find innovative approaches to meet the different priorities which aim to reduce economic industry burden and ensure product availability.

  • AdobeStock_450503295 (1)

    IVDs and medical devices — post-market surveillance and clinical follow-up requirements


    Written by Kirsten Van Garsse from Qarad (part of the QbD Group) based on an online seminar presentation, made in collaboration with TOPRA and QbD, given on 6 December 2022 by Kirsten Van Garsse and Anne-Sophie Grell from QbD.

  • Patient information, why do things go wrong?

    Patient information — why do things go wrong?


    Are common root causes leading to the pharmaceutical industry being non-compliant with the legal obligation to keep authorised product information up to date?

  • AdobeStock_507177586

    A View of…The Environmental Impact of Pharmaceuticals


    The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.

  • AdobeStock_214876031 (2)

    Quality management systems — applying good distribution practices to the biopharmaceutical supply chain


    Biopharmaceutical supply chain strategies and alignment with good distribution practices (GDPs) are often viewed and planned with a focus on the post-marketing stage. Although this approach is valid, GDP compliance and supply chain strategies have important implications even during the clinical phases of product development. GDP regulations ensure that the integrity of medicinal products is maintained throughout all stages of the supply chain, from the manufacturer’s site to the pharmacy, or person authorised to supply to the public.

  • AdobeStock_497948986 (1)

    Successful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR


    The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.

  • picture 11111

    Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR


    European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.

  • European regulatory fees

    European regulatory fees – complexity, concerns and solutions for efficiency


    Regulatory authorities charge fees for the services they provide related to marketing authorisations. This research aimed to understand the complexity and concerns around the fee calculation and payment process for EU procedures used for market approval of a drug and proposes potential solutions to improve efficiency.

  • AdobeStock_195160233

    An integrated approach to collecting patient experience data: An industry perspective


    Patient experience data (PED) are intended to provide information about patients’ experiences with a disease or condition. There is growing interest from multiple stakeholders, including pharmaceutical companies to collect PED to inform the development and commercialisation of new drugs. Present efforts to generate PED ofen result in disjointed, overlapping, or duplicated efforts within and between pharmaceutical companies. 

  • The application of patient preference information

    The application of patient preference information


    Regulatory authorities are encouraging the submission of patient experience data, including patient preference information (PPI). We provide an overview of PPI and the use of PPI in the regulatory setting. Many PP health studies recognise the usefulness of PPI, however, challenges remain in defining how and when to incorporate it in the regulatory process. While the use of PPI in regulatory decisions has been limited, regulatory agencies, sponsors, and researchers continue to work together to develop guidelines to integrate PPI into approval decisions.

  • RR-Jan-2023-300x
  • RR-Cover-Dec-2022-300px
  • Greg Perry, Assistant Director General at International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

    TOPRA Annual Lecture:
    Access to medicines beyond Europe:
    The potential of reliance


    Greg Perry, Assistant Director General, discussed in this year’s annual lecture, learnings on the IFPMA and the impact of the COVID-19 pandemic on Africa. In particular, the importance of building a strong infrastructure within the continent, in relation to the establishment of the AMA.