CREATInG Initiative Regulatory Functional Training November 2025

DH RegSys participated in the CREATInG Initiative Regulatory Functional Training programme, focused on Regulatory Frameworks and Requirements for in-vitro diagnostics (IVDs). The 3-day course was co-launched by the Duke-NUS Medical School Centre of Regulatory Excellence (CoRE) and Duke Kunshan University as part of the CREATInG Initiative funded by the Gates Foundation.

Grounded in real-world case studies, the programme was enriched with insights from regulatory experts from Singapore’s Health Sciences Authority, the WHO Prequalification IVD Assessment Team, CoRE, and DH RegSys. Participants were guided through key international regulatory frameworks, including the US FDA, EU, and ASEAN systems.

The training also featured interactive case discussions on product risk classifications and go-to-market strategies, enabling participants to apply their learning by developing their own regulatory filing strategies.

GHWP 2024

DH RegSys participated in the 28th Global Harmonization Working Party’s (GHWP) Annual Meeting at Kuala Lumpur. It was held between the 9th to the 12th of December 2024.
Hwee Ee, a member of Work Group (WG) 7 – Quality Management System, attended the WG7’s meeting.

More information on GHWP and workgroup activities can be found at www.ahwp.info.

AusMedtech 2024

DH RegSys participated in AusMedtech, Australia’s premier medical technology conference.
With the support of the organiser, we conducted a pre-conference workshop on “ASEAN medical device regulations”. 

Hwee Ee was also a panel speaker on the topic “How to Navigate MDR, why is the EU different now?”.

AusMedtech 2023

DH RegSys participated in AusMedtech, Australia’s premier medical technology conference.

Hwee Ee was also a panel speaker on the topic “Global Convergence of Regulations – Fact or Fiction”.

ASGH 2023

DH RegSys participated in Asia Summit on Global Health (ASGH), Asia’s premier event on health innovation and investment.