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  • Regulatory Rapporteur - June 2025
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  • Regulatory Rapporteur - June 2025
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • FDAPLAT final
      ​Navigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
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      Navigating orphan drug designation in the EU
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      Prescribing efficiency: Using generative artificial intelligence for pharmacovigilance
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    • RR-June-2025-half cover _masthead
      June 2025 – Contents
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      Veterinary medicines: Translating regulation into practice
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
    • SUSIMPERATIVE_compressed
      The sustainability imperative for the healthcare sector
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      The EU Medical Device Regulation: Balancing innovation with regulation
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      Medical device regulation: Challenges, innovation and the future
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      November 2024 – Contents: Medical devices/IVDs sessions
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      Extension to ​ICMRA post-approval change collaborative pilots
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      NHS app opens access to trials for UK patients
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      Updated post-market surveillance requirements take effect
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      RegRapPod − InConversation with Hugues Malonne
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      Veterinary medicines: Translating regulation into practice
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      Advanced therapies: A maturing regulatory framework
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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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Product Information Stories

  • Patient information, why do things go wrong?

    Patient information — why do things go wrong?

    2023-02-07T09:26:00+00:00By Rory Littlebury

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    Part 1: EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome?

    2022-06-22T14:53:00+01:00By Sarah Landra (née Laird)

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    Electronic leaflet pilot in Belgium and Luxembourg hospitals

    2022-03-23T11:07:00+00:00By Nathalie Lambot and Marie Vande Ginste

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