2024 DIA Singapore Annual Conference Session on New Regulatory Fields and Trends
Finny Liu, at
“2024 DIA Singapore Annual Conference Session 3: New Regulatory Fields and Trends. It’s a great pleasure to chair this session together with Jack Wang.
We have very diversified topics in this session but all are very interesting topics.
Kwan Ling from HSA shared the regulatory framework for AI products in Singapore. She gave us a clear picture of how AI is regulated and the relevant guidelines available.
Greg shared AI in Action and the real world regulations from Industry perspective. Risk of AI is real as well as Benefit is real. Industry regulates AI not just regulators.
Jeffery shared the Accumulus Synergy & Regulatory Innovation in the Cloud. Cloud-based technology can improve the way regulators and drug developers interact. 37 NRAs have used the Accumulus platform in a CMC post-approval change reliance pilot. Accumulus is focused on broadening stakeholder engagements worldwide.
Jack shared the background, scope, opportunities & challenges, and tips of the Guangdong-Hong Kong-Macao Greater Bay Area Pathway, which permits designated healthcare institutions in the GBA to utilize urgently needed drugs and medical devices.
Christine shared Emerging Evidence-Based Longevity Medicine and Products. The regulatory strategy starts from Recognizing aging as a treatable condition, followed by Flexible clinical trial design, Public-private partnerships, Harmonization of international regulations, Encouraging RWE with digital health technologies, and finally Collaboration with ethical and legal experts.
Kai Yin shared the Continuous Manufacturing Overview, Advantages, Current Regulatory Landscape and Future Considerations.
Currently, for small molecules at least 13 countries approved products with CM, but no end to end CM process in biological products have been approved. However, about 20 biological products manufactured in perfusion processes have been approved by the US FDA.
Thanks to all speakers for sharing with us such great insights on these topics.”
Source: Finny Liu/LinkedIn