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