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  • Regulatory Rapporteur - December 2024
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    The Organisation for Professionals in Regulatory Affairs
  • 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
  • Veterinary
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
    • SUSIMPERATIVE_compressed
      The sustainability imperative for the healthcare sector
    • AdobeStock_537705324
      New data protection for maximum residue limits
    • AdobeStock_294025271
      EMA platform to monitor use of antimicrobials
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Medical devices/IVDs sessions
    • elabels image_compressed
      E-labelling: revolutionising the labelling landscape
    • AdobeStock_841428142_compressed
      New approach methodologies for the biological safety assessment of medical devices
  • Industry news
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    • final alzimer article image
      Increased debate over lecanemab
    • EMA medicine shortages final image
      Use of new EMA platform for monitoring medicine shortages to become mandatory
    • GSK blood cancer article final image
      GSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
  • Commentary
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    • AdobeStock_282144604

      North America:
      Navigating key regulatory updates
    • Michael Kipping
      Improving health outcomes through regulatory excellence
    • AdobeStock_971129498_SMALL
      Chemistry, manufacturing and controls: accelerating development and boosting innovation
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    • Banner_new
      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
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      The Olaratumab experience
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      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
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All Regulatory Rapporteur articles in December 2024

View all stories from this issue.

  • final article image
    Journal

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

    2024-12-06T11:55:00Z

     

  • CTR article image final
    Journal

    Transitioning to the Clinical Trials Regulation: The Roche experience

    2024-12-06T11:55:00Z

     

  • final image
    Journal

    Shedding light on essential drug delivery outputs

    2024-12-06T11:54:00Z

     

  • 4. same image in previous MedDev updates
    Journal

    Medical device standards update: December 2024

    2024-12-06T11:54:00Z

     

  • final article image
    Journal

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

    2024-12-06T11:53:00Z

     

  • AdobeStock_823948113
    Journal

    Notable US Food and Drug Administration pilot programmes

    2024-12-06T11:53:00Z

     

  • AdobeStock_282144604
    Editorial


    North America:
    Navigating key regulatory updates

    2024-12-03T15:00:00Z

     

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