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  • Regulatory Rapporteur - November 2026
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  • Regulatory Rapporteur - November 2026
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • AdobeStock_480758443 - main image
      The end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation
    • AdobeStock_225676932 - main image
      IDMP after the API: From one-time submission to living data governance
    • AdobeStock_1072348421- main image
      Mapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration
  • Veterinary
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      Latin America: From low-cost venue to strategic platform in veterinary clinical research
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      A lifecycle oversight of veterinary medicines regulation in Latin America
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      A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
    • Jana Schalansky
      November 2025 – Contents: Veterinary medicines sessions
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
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      The FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
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      China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
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      From regulation to implementation: Medical device serialisation and traceability in India
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      UK confirms indefinite recognition of CE-marked medical devices
    • FDA pilot accelerated IND image
      FDA introduces new pilot programme to accelerate early-stage clinical research
    • EMA pre-submission pilot 2
      EMA launches new pre-submission interactions model pilot
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      The Americas: Navigating regulatory convergence and divergence
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      Clinical trial design and real-world evidence: What happens to the evidence next?
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      RegRapPod − InConversation with TMC Pharma
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      The Olaratumab experience
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Pharmaceutical latest

  • Nov half cover_final hi res

    Regulatory Rapporteur November 2026 – Contents

    2026-11-10T12:30:00+00:00

  • AdobeStock_480758443 - main image

    The end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation

    2026-11-10T09:26:00+00:00

  • AdobeStock_225676932 - main image

    IDMP after the API: From one-time submission to living data governance

    2026-11-09T15:01:00+00:00

  • AdobeStock_1072348421- main image

    Mapping early and often FDA interaction in rare disease programmes: Building the path from discovery to registration

    2026-11-06T15:36:00+00:00

  • AdobeStock_459536022 - main image

    Navigating the fragmented US approach to AI governance: What FDA guidance, State legislation, and divergence from the EU AI Act mean for regulatory teams

    2026-11-04T17:24:00+00:00

  • AdobeStock_2034371404 - main image

    Colombia’s regulatory landscape: Opportunities and barriers

    2026-11-04T12:57:00+00:00



  • Final half cover image

    Regulatory Rapporteur October 2026 – Contents

    2026-10-07T14:29:00+01:00

  • ICH main image

    ICH Q6(R1): Harmonising specifications for chemical and biological products

    2026-10-07T10:14:00+01:00

  • DATA main image

    The compounding pharmaceutical data gap: The impact of structural under-representation on AI-augmented pharmacovigilance systems

    2026-10-07T08:48:00+01:00

  • PAEDIATRIC main image

    Moving towards one global paediatric development plan

    2026-10-06T15:07:00+01:00

  • COMBINE main image

    COMBINE EU pilots: Roche’s experience as first pilot participants

    2026-10-06T14:11:00+01:00

  • FINLAND main image

    Multistakeholder collaboration to translate the ICH GCP E6(R3) guideline into Finnish: Supporting clinical trial conduct in Finland

    2026-10-06T13:25:00+01:00

  • DIVERSITY main image

    Clinical trial diversity and regulatory decision-making: Implications for dosing, safety and global alignment

    2026-10-06T10:06:00+01:00

  • EVOLVE main image

    The evolving regulatory framework for clinical data management in the era of decentralised trials

    2026-10-05T15:11:00+01:00

  • LEAN main image

    Lean writing and disclosure-ready principles for clinical trial design and documents

    2026-10-05T14:18:00+01:00

  • FDA pilot accelerated IND image

    FDA introduces new pilot programme to accelerate early-stage clinical research

    2026-09-29T09:25:00+01:00

  • EMA pre-submission pilot 2

    EMA launches new pre-submission interactions model pilot

    2026-09-28T10:31:00+01:00

  • AdobeStock_1527594934

    FDA launches final guidance on therapeutic equivalence evaluations

    2026-09-17T14:05:00+01:00

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