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Vladimir Makarov

Vladimir Makarov

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Work area in Google drive: https://drive.google.com/drive/folders/121fs44l87YyUTkLKDXFCLJZAXwbaKiAV?usp=drive_link MS Sharepoint: Regulatory

Range of ideas

  • Generate Common Technical Documents with LLMs, GenAI, and ontologies

    • Common requirements and technology evaluation

    • Rapid draft of comprehensive and compliant communications tailored to key
      stakeholders including regulatory bodies, healthcare professionals and patients

  • Industry-wide common submission of recommendations to the regulatory authorities in response to their requests for comments

  • Automated monitoring of changes in regulatory guidelines reducing the risk of
    non-compliance

  • Automated Q&A on regulatory topics derived from regulatory texts and precedents

    • Leading to planning of regulatory strategy and automated competitive intelligence
      research

  • Labelling and Packaging drafting and compliance

  • Education and Lifecycle Management: Highly efficient knowledge transfer of regulatory
    history and rationale to professionals assuming responsibility for existing products

  • Key to success: Regulatory Compliance Ontology

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