Work area in 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
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
Meeting Minutes
2024.04.23
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+), link
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)
2024.06.05
Our call today was recorded. Please refer to:
https://pistoiaalliance-org.zoom.us/rec/share/EjY3A6mpVo4ve-t6vq-rZajJ4-SetbsI-imjvevXBpAbrgtwE-YZJFC9eTVVWx5C.4u6u6mqZC7i7kEHL
Passcode: vHt^5Au3
Main discussion points:
Sridevi wrote a paper on use cases in AI: https://globalforum.diaglobal.org/issue/june-2024/demystifying-ai-in-healthcare-common-challenges-ai-can-help-solve/
Prioritize use cases
Do not build solutions
Input from users most important, and we should seek additional project contributors among colleagues who can add to the understanding of business needs
Assign business value to use cases
Determine enabling technologies that drive many use cases
Holistic outlook at the global regulatory acceptance for AI
Think ahead of the regulatory groups because regulatory agencies need our input
Sridevi: should we organize a f2f workshop with whiteboarding?
Cannot wait for the PA Fall conference, it would be too late. Ideally, meet in the summer, brainstorm, and use the Fall conference only to report the findings
VM + JA to create agenda for this (New action item)
Tim to organize logistics (Another new action item)
A kind reminder about our other action items:
Tim Hoctor to share links to publications by regulatory agencies that seek responses and comments; we can use these to write a collective response
Collective action item: identify and involve additional people
Webinars related to this topic
Other organizations
