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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
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      November 2024 – Contents: Human medicines sessions
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      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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      The Olaratumab experience
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      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
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Non-Clinical Development Stories

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    Nonclinical immunogenicity evaluation in toxicology studies of biopharmaceuticals

    2021-12-23T10:53:00+00:00By Sebastian Joseph

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