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  • Regulatory Rapporteur - December 2024
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  • Regulatory Rapporteur - December 2024
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • CTR article image final
      Transitioning to the Clinical Trials Regulation: The Roche experience
    • RR-Dec-2024-Half-cover
      December 2024 – Contents
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Human medicines sessions
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    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
    • SUSIMPERATIVE_compressed
      The sustainability imperative for the healthcare sector
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      New data protection for maximum residue limits
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      EMA platform to monitor use of antimicrobials
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    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Medical devices/IVDs sessions
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      E-labelling: revolutionising the labelling landscape
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      New approach methodologies for the biological safety assessment of medical devices
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      Increased debate over lecanemab
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      Use of new EMA platform for monitoring medicine shortages to become mandatory
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      GSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
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      North America:
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      Improving health outcomes through regulatory excellence
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      Chemistry, manufacturing and controls: accelerating development and boosting innovation
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      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
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Pharmaceutical latest

  • RR-Nov-2024-Half-Cover

    November 2024 – Contents

    2024-12-06T15:14:00+00:00

  • final article image

    Early development of vaccines and prophylactics in infectious diseases: A post-pandemic regulatory overview

    2024-12-06T11:55:00+00:00

  • CTR article image final

    Transitioning to the Clinical Trials Regulation: The Roche experience

    2024-12-06T11:55:00+00:00

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    Shedding light on essential drug delivery outputs

    2024-12-06T11:54:00+00:00

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    Notable US Food and Drug Administration pilot programmes

    2024-12-06T11:53:00+00:00

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    Health Canada: Points to consider when preparing quality and new substance notification documentation for investigational medicinal products

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  • RR-Dec-2024-Half-cover

    December 2024 – Contents

    2024-12-05T17:16:00+00:00

  • AnnualLecture - IlonaKickbusch

    TOPRA annual lecture: Status of global health

    2024-11-08T06:55:00+00:00

  • HM9 - ChristineGrew

    HM9: Clinical trial applications - EU Clinical Trial Regulation and beyond

    2024-11-08T06:53:00+00:00

  • HM8 - CarlosLangezaal

    HM8: How the new EU regulation on health technology assessment (HTA) will change clinical drug development and regulatory affairs

    2024-11-08T06:53:00+00:00

  • HM6 - RebeccaLumsden

    HM6: Artificial Intelligence – How will AI and machine learning tools transform regulatory practice?

    2024-11-08T06:52:00+00:00

  • HM7 - Denise Umuhire

    HM7: Clinical evidence generation in Europe – Is it time for a more holistic view of global healthcare product development?

    2024-11-08T06:52:00+00:00

  • HM1 - SabineHaubenreisser

    HM1: Ensuring regulatory excellence

    2024-11-08T06:51:00+00:00

  • HM3 - FrancescaButtigieg

    HM3: Regulation and innovation – Keeping up with the times (Fireside chat)

    2024-11-08T06:51:00+00:00

  • HM4 - KatjaPečjakReven

    HM4: Electronic product information (ePI) – A digital passport for medicinal product information

    2024-11-08T06:51:00+00:00

  • HM2 ALT - Lada Leyens

    HM2: European clinical research ecosystem – How to boost its competitiveness

    2024-11-08T06:51:00+00:00

  • RR-Nov-2024-Half-Cover

    November 2024 – Contents: Human medicines sessions

    2024-11-07T15:57:00+00:00

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    Revolutionising compliance with DADI: a new frontier for digital integration

    2024-10-11T10:25:00+01:00

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