Interest from many PA members

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

• 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