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  • Regulatory Rapporteur - January 2025
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  • Regulatory Rapporteur - January 2025
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • ROLEOFAI_final_compressed
      The role of artificial intelligence in regulatory affairs
    • GENDEVS
      Considerations for generics developers moving into the field of biosimilars
    • RR-Jan-2025- half cover
      January 2025 – Contents
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    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
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      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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      MHRA issues guidance on post-market surveillance regulation in Great Britain
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      ICH releases M15 Guideline on Model-informed Drug Development
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      Biologics development: Overcoming regulatory hurdles
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      North America:
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      Improving health outcomes through regulatory excellence
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Pharmaceutical latest

  • ROLEOFAI_final_compressed

    The role of artificial intelligence in regulatory affairs

    2025-01-10T08:54:00+00:00

  • GENDEVS

    Considerations for generics developers moving into the field of biosimilars

    2025-01-10T08:49:00+00:00

  • RR-Jan-2025- half cover

    January 2025 – Contents

    2025-01-08T17:19:00+00:00

  • 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



  • final image

    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

  • final article image

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

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

  • 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

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