Centre of Regulatory Excellence

What are the requirements for clinical data to meet regulatory standards? ? Today, participants at the Graduate Certificate for Clinical Studies and Evaluation of Health Products will explore regulatory requirements to support market approvals of pharmaceuticals, medical devices and technologies. From understanding standards and processes for submitting an application to evaluating the benefit-risk profile of a health product, the course will break down what it takes to ensure quality, safety and efficacy of the products. ? Missed the registration for the workshop? Save your seat now for upcoming courses at https://lnkd.in/gF8GzG-s

Successful AI deployment is all about people, processes, and partnerships! This was the key message unpacked from the panel on “Last-Mile Adoption of AI in Healthcare” at the AI Health World Summit, where Prof John Lim, CoRE’s Executive Director, along with other experts discussed the real-world challenges of integrating AI into clinical practice. The discussion emphasised that technology alone isn’t enough—building trust, ensuring seamless workflow integration, and demonstrating real-world value are essential for adoption. A big thank you to moderator Prof Alex Sia, co-panellists Prof Ernst Kuipers, Dr Jeffrey Goldberg, and Prof Aymeric Lim, and the engaged audience for the insightful exchange. Continuing this conversation, CoRE’s Asst Prof Dr. Kavitha Palaniappan will moderate a session on “Trust in the Time of Healthcare AI: What do Doctors and Patients Need?” on 21st March (Friday) from 2.55pm to 3.40pm at L1S1, Academia. Do join and be part of this important discussion. CoRE looks forward to advancing agile regulations to bridge the gap between AI innovation and impactful implementation!

Join us for an insightful panel discussion on “Trust in the Time of Healthcare AI: What do Doctors and Patients Need?” as a parallel track to the main conference at the AI Health World Summit on 21st March (Friday) 2025 from 2.55pm to 3.40pm at L1S1, Academia. This panel discussion moderated by Asst Prof Dr. Kavitha Palaniappan from CoRE aims to explore how AI is transforming healthcare and what it takes to build trust among patients and clinicians. Dr Qi Wei Fong and Dr Rachel Lim will share their experiences on AI in practice – opportunities, challenges and ethical considerations, while Mr Ellil Mathiyan Lakshmanan and Mr Rajakanth R will highlight what truly matters to patients in an AI-driven healthcare system. Don’t miss this engaging conversation – Register here: https://healthsummit.ai/

The?three-part explainer series?Vaccine Manufacturing and Regulatory Systems Strengthening, produced jointly by CoRE and the Asian Development Bank (ADB), is now available on?CoRE’s platform -- https://lnkd.in/ddSrFmAb?and?Development Asia, ADB’s knowledge collaboration platform.?--?https://lnkd.in/d9Hk6qkg ? 1.???Enhancing Vaccine Regulation for Pandemic Preparedness?proposes cooperative strategies to?facilitate vaccine approval and distribution in?Asia and the Pacific. — https://lnkd.in/gFv6_P8Q ? 2.???Building Sustainable Vaccine Practices in Lower-Resourced Settings examines challenges?in the sustainability of vaccine manufacturing and policy actions to overcome barriers.?— https://lnkd.in/dQ68E8SS ? 3.???Ensuring?Sustainable, Locally Relevant Vaccine Research and Development in Resource-Limited Settings?discusses?R&D investments in various platforms and factors that determine vaccine development success in resource-limited countries.?—?https://lnkd.in/dgTYPVAS ? Delve deeper by reading the ADB-CoRE Vaccine Regulation?Project Highlights and Recommendations?(https://lnkd.in/dmZ25zPG)?and?Regional Vaccine Regulatory Landscape Analysis and Recommendations?(https://lnkd.in/dJkRZTKw) These publications and in-country capacity building workshops reflect a collaborative effort under the leadership and guidance of Prof?John Lim,?Dr Eduardo Banzon, Prof?Silke Vogel,?and?Dr Dr Dinesh Arora as well as the support of Asst Prof Wei Chuen Tan-Koi, Dr Jae Kyoun Kim, Jessalyn Chan, Dr Ye Xu, Asst Prof Yoong Khean Khoo, Dr Ben Coghlan, Asst Prof James Leong, Dr Uttara Soumyanarayanan, Ph.D.,?Asst. Prof Rukie de Alwis,?Asst?Prof Anne-Claire Stona, MD, MSc,?Assoc Prof Taufique Joarder, Serene Ng, michelle apostol, Sheela Myla O. Rances, Cecilia C. Bantugon, Ma Antoniette Bihis,?Dr Sungsup Ra and Dr Patrick Osewe Development Asia

?? Register now! ?? CoRE invites you to a new workshop on “Good Manufacturing and Laboratory Practices for Pharmaceutical, Biotech, and Medical Devices: Operational Excellence from R&D to GMP Compliance”. ?? Date: 27 - 28 March 2025 (Session 1) and 3 - 4 April 2025 (Session 2) ?? Location: Duke-NUS Medical School, 5C This in-depth workshop is designed for professionals in the pharmaceutical, biotech, and medical device sectors who are seeking to enhance their understanding and operational knowledge of GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices). The workshop will be conducted over two sessions, with experienced speakers from SeerPharma. Equip yourself with the operational aspects of GMP compliance for health products, focusing on the key operational challenges that arise as companies transition from R&D to GMP-compliant environments. Secure your spot today: https://lnkd.in/g2p3-7Xw #GoodManufacturingPractices #GoodLaboratoryPractices #GMPCompliance #CoRE #DukeNUS #Pharmaceuticals #Biotech #MedicalDevice

To our incredible women team members of CoRE — we celebrate your achievements, impact and excellence. Here’s to honoring your contributions today and every day! Silke Vogel Sherna Wadia Dr. Kavitha Palaniappan Wei Chuen Tan-Koi Stefanie Tan Rathi Saravanan Fan Y. Chandrani Ghosh Anne-Claire Stona, MD, MSc Huay Ee Cheng Devaki Sundram Faith Tan. Jessalyn Chan Elaine Lin Uttara Soumyanarayanan, Ph.D. Natasha Amalina Sabiha Khan Serene Ng Nur Bazilah Abu Baker #IWD2025 #AccelerateAction #WomenInHealth #RegulatoryExcellence #CoRE

Today, we co-hosted a seminar with the Centre for Outbreak Preparedness, where Prof Suerie Moon shared findings from her five-year research on alternative R&D models. She examined how these models can overcome the limitations of traditional models and drive innovation and equitable access, particularly in Asia. Prof John Lim provided insights on regulatory cooperative networks, the role of enabling regulations, and opportunities for alternative R&D models in ASEAN and the Global South. This sparked a dynamic discussion on how new models in Asia could offer fresh, innovative approaches to pharmaceutical R&D, skillfully moderated by our CoRE colleague, Asst Prof Wei Chuen Tan-Koi #CoRe #DukeNUS #GlobalHealth

?? The "Value of USP Biologics Standards" workshop today was an insightful exploration of the future of biologics, focusing on US Pharmacopeia's (USP) efforts to develop quality standards for cell and gene therapy products. ?? Attendees learned about the challenges in CAR T manufacturing and how USP standards and reference materials are shaping the next generation of biologics. The session also opened exciting opportunities for collaboration and innovation across stakeholders. ?? Thank you to everyone who participated and contributed to making this workshop a success! #USP #CoRE #Biologics #GeneTherapy #CARtherapy #AAVSolutions #PharmacopeialStandards

Join Prof Suerie Moon as she presents key insights from a five-year study on alternative innovation models, highlighting case studies on neglected diseases, rare diseases, and antibiotics. Prof John Lim will also share perspectives from Singapore and ASEAN on regulatory frameworks that enable innovation. Don't miss out, Register now:?https://lnkd.in/gmbUMTTx Elyssa L. Wei Chuen Tan-Koi Yimei Sun #CoRE #DukeNUS #GlobalHealth

How can we rethink medical innovation to tackle critical health challenges? Join Prof Suerie Moon to discover insights from a five-year study on alternative innovation models and case studies on neglected diseases, rare diseases and antibiotics. Prof John Lim, Executive Director of Duke-NUS Centre of Regulatory Excellence, will also share lessons from Singapore and ASEAN on regulatory frameworks that support innovation. ? Register here:?https://lnkd.in/gmbUMTTx ? #DukeNUS #DukeNUSCOP #GlobalHealth ? Elyssa L. Wei Chuen Tan-Koi Yimei Sun