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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
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    • 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
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      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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      ​FDA to replace animal testing with new approach methodologies
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      EMA to address antimicrobial resistance risks from veterinary medicinal products
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      ​MHRA authorises new cancer treatment variation with significantly reduced administration time
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      Veterinary medicines: Translating regulation into practice
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      Advanced therapies: A maturing regulatory framework
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      RegRapPod − InConversation with Ivo Claassen
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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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Advanced Therapy Medicinal Products

  • CANCER image final

    Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment

    2025-05-02T13:41:00+01:00

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    ​Case studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans

    2025-05-02T13:41:00+01:00

  • RR-May-2025-half_cover

    May 2025 – Contents

    2025-05-01T14:56:00+01:00

  • GTMP final

    ​Gene Therapy Medicinal Products: An examination of regulatory CMC requirements

    2025-05-01T09:43:00+01:00

  • ATMPs news image 3

    EMA accepts new guidelines on investigational ATMPs

    2025-02-17T12:54:00+00:00

  • licensed image (2)

    Considerations in the development of allogenic and autologous cell therapies

    2025-01-10T08:51:00+00:00



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    Small interfering RNA: regulatory challenges and therapeutic potential

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

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    Near-term challenges of advanced therapy medicinal products: a maturing product class

    2024-05-17T08:24:00+01:00

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    RegRapPod − May 2024

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    Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU

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  • CRISPR-Cas9 gene editing technology

    The first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy

    2024-05-08T10:30:00+01:00

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    Near-term challenges of advanced therapy medicinal products: a maturing product class

    2024-05-08T10:00:00+01:00

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