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Vladimir Makarov

Vladimir Makarov

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Interest from many PA membersWork area in Google drive: https://drive.google.com/drive/folders/121fs44l87YyUTkLKDXFCLJZAXwbaKiAV?usp=drive_link

Range of ideas

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  • 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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Meeting Minutes

2024.05.15

  • Slides

  • Participants:

    • Beatriz & Gabriel, Vitality Tech Net

    • James Averback, PA

    • Loganathan Kumarasamy, Zifo

    • Joseph Mullen, ELS-CBH

    • Sridevi Nagarajan, AZ

    • Karin Schneider, J&J

    • Adarsh Srivastava, Roche

    • Tim Hoctor, PA

    • John Wise, PA

    • Vladimir Makarov (organizer), PA

  • Main discussion points:

    • Jim Averback has a detailed list of possible use cases (30+), the spreadsheet with this information will be posted online (Action item)

    • Karin has an in-house list of 400+ use cases

    • Tim Hoctor proposed writing a team response to the requests for comments by the regulatory authorities; Tim will share the links to relevant publications (Action item)

    • There is a desire on part of multiple group members to remove the “black box” image of AI, introduce recommendations for solutions for specific use cases (“Recommendation engine”)

    • There is also a desire on part of multiple group members to develop a common vision of the future (“How will the regulatory submissions look in X years?”), link known use cases to this strategic vision. This is also related to Tim’s proposal to create collective responses to regulators. A common vision may also help harmonize regional regulatory demands

    • Collective action item: identify and involve additional people (Action item)

    • Vladimir to send a poll to set-up another meeting in roughly 2 weeks time

Webinars related to this topic

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