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  • Regulatory Rapporteur - July/August 2025
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • Diversity licensed image
      ​Diversity in clinical research: Regulatory considerations and updates
    • EUPATI licensed image
      Patient involvement in the regulatory area: Insights into national level dialogues
    • PPI licensed image
      ​The evolving landscape of public and patient involvement
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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
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      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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      EFPIA publishes guidance document to help support novel methodology submissions
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      ​New Director appointed at the FDA’s Center for Drug Evaluation and Research
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      ​FDA makes labelling changes to opioid products mandatory
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      RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
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      Patient voice: Shaping the future of medicine regulation
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      RegRapPod − InConversation with Hugues Malonne
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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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Pharmaceutical latest

  • FDAMANU licensed

    FDA comparability guidance: The impact of cell and gene therapy products

    2025-07-11T10:26:00+01:00

  • Diversity licensed image

    ​Diversity in clinical research: Regulatory considerations and updates

    2025-07-11T10:23:00+01:00

  • ODD licensed image (2)

    ​The importance of patient advocacy in the EMA ODD process

    2025-07-11T10:22:00+01:00

  • EUPATI licensed image

    Patient involvement in the regulatory area: Insights into national level dialogues

    2025-07-11T10:22:00+01:00

  • PRAGMATIC licensed image

    ​Realising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials

    2025-07-11T10:22:00+01:00

  • PPI licensed image

    ​The evolving landscape of public and patient involvement

    2025-07-11T10:21:00+01:00



  • RR_July_masthead_halfcover

    July/August 2025 – Contents

    2025-07-11T08:17:00+01:00

  • RR issue cover licensed final

    Patient voice: Shaping the future of medicine regulation

    2025-07-10T14:28:00+01:00

  • AdobeStock_521314530_Editorial_Use_Only

    NHS app opens access to trials for UK patients

    2025-06-23T09:44:00+01:00

  • TOPRA FAMHP Podcast 800x533px (6.4 ratio) V1

    RegRapPod − InConversation with Hugues Malonne

    2025-06-18T16:55:00+01:00

  • TRUST final

    Sandbox of trust: Regulated AI for health promotion and disease prevention

    2025-06-06T14:07:00+01:00

  • FDAPLAT final

    ​Navigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers

    2025-05-02T13:42:00+01:00

  • AIFORPV_final image

    Prescribing efficiency: Using generative artificial intelligence for pharmacovigilance

    2025-05-02T13:42:00+01:00

  • ODD licensed image

    Navigating orphan drug designation in the EU

    2025-05-02T13:42:00+01:00

  • 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

  • 6. cover image idea 6

    Advanced therapies: A maturing regulatory framework

    2025-05-02T13:40:00+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

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