Nancy Pire-Smerkanich

Nancy Pire-Smerkanich is Assistant Professor, Department of Regulatory and Quality Sciences, at University of Southern California School of Pharmacy, US. She is a member of the TOPRA Editorial Board.

  • Setting the right standards
    Editorial

    Setting the right standards

    2023-03-07T13:39:00

    The theme of this issue is global standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.

  • AdobeStock_242940510
    Editorial

    Adapting, transforming and innovating

    2022-10-31T14:40:00

    For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...

  • Tyner Headshot 2020
    Journal

    The power of collaboration

    2022-10-31T14:40:00

    Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.

  • AdobeStock_393791829
    Focus

    Data governance as a strategic imperative for regulatory compliance

    2022-06-22T14:42:00

    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 ...

  • covid
    Editorial

    What does 2022 have in store for clinical trials?

    2021-12-23T13:39:00

    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