All Regulatory Rapporteur articles in January 2023

View all stories from this issue.

  • Science is more than you think
    Article

    ‘Science is more than a body of knowledge.
    It’s a way of thinking’*

    2023-01-04T11:16:00Z

    Following the launch of Regulatory Rapporteur on an online publishing platform earlier this year, our efforts are now focused on ensuring that we provide the best possible online journal experience for our members.

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    Editorial

    Patient evidence and engagement

    2023-01-04T11:14:00Z

    Don’t we in Life Sciences excel at generating abbreviations and acronyms? For example, do you know your COA from your PED or PPI? Or PEE from PRO? If you don’t, an explanation will be forthcoming in this edition of the Regulatory Rapporteur.

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    Article

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

    2023-01-04T10:39:31.687Z

    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.

  • Quality: Partnering rather than policing?
    Letter to the editor

    Quality: Partnering rather than policing?

    2023-01-04T10:39:00Z

    My 25 years in industry started as a laboratory analyst before moving into Quality within mid-size Pharma biotech, and latterly focused on Phases 2 and 3. Fundamentally, clients (whether internal within a company or on an external consultancy basis) make contact when Regulators are imminently coming, when a new Executive ...

  • Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA
    Interview

    Every patient has a story to tell us

    2023-01-04T10:39:00Z

    Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA, discusses his career, his inspirations, and why it is important to involve patients in regulatory decisions.

  • European regulatory fees
    Article

    European regulatory fees – complexity, concerns and solutions for efficiency

    2023-01-04T10:39:00Z

    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.

  • The evolving regulatory environment
    Case Study

    Case study: The evolving regulatory environment

    2023-01-04T10:39:00Z

    Reproduced from a webinar presentation, made in collaboration with TOPRA and Roche, given on December 15 by Caroline Kuhn, François Hebraud, and Vijay Reddi, of Roche.

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    Article

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

    2023-01-04T10:39:00Z

    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
    Article

    The application of patient preference information

    2023-01-04T10:39:00Z

    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.