All Regulatory Rapporteur articles in January 2023

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  • Science is more than you think

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


    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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    Patient evidence and engagement


    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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    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.

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

    Quality: Partnering rather than policing?


    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

    Every patient has a story to tell us


    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

    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.

  • The evolving regulatory environment
    Case Study

    Case study: The evolving regulatory environment


    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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    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.