Work area in Google drive: https://drive.google.com/drive/folders/121fs44l87YyUTkLKDXFCLJZAXwbaKiAV?usp=drive_link
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-complianceAutomated 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 productsKey to success: Regulatory Compliance Ontology
Meeting Minutes
2024.05.15
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
2021.07.28 Challenges in the regulation of AI Software as a Medical Device
2022.08.03 Trustworthy AI
2024.01.23 Emerging Regulations of AI – Impact on Pharma R&D
Other organizations
Society for Digital Pathology is also citing regulatory materials and organizing surveys in this space