CoRE2025HIGHLIGHTS
CONTENTS03MESSAGE FROM EXECUTIVE DIRECTOR04OUR YEAR IN NUMBERS06OUR PEOPLE07OUR PURPOSE22OUR PARTNERS24 ADVISORY BOARD26 LOOKING AHEAD
MESSAGE FROM EXECUTIVE DIRECTORPROFESSOR JOHN LIMSince CoRE’s establishment, our journey has been defined by ourpeople, our purpose, and our partners.We have grown from a bold idea into a trusted institution, unitingregulators, policymakers, industry, and academics in advancingregulatory science and health policy for the public good.The partnerships we have built and the diverse areas we haveadvanced reflect the unwavering commitment of our team and thetrust of our stakeholders.Together, we continue to drive CoRE’s leadership in shapingframeworks, strengthening systems, and fostering innovation intomeasurable impact that improves health outcomesacross Asia and beyond.3
OUR YEARIN NUMBERS 2Graduate CertificateProgrammes inPharmaceutical andMedical TechnologyRegulation70Local, regional andinternationalorganisationspartnered14,000+ *Participants since2014200+Local andInternationalfaculty members70+Think-tank activitiesfrom focus groupsand roundtables toseminars andconferencesImpact drives our work at CoRE, as we advance regulatoryexcellence and strengthen health systems. From cultivating skilledprofessionals to informing policy, driving thought leadership andfostering innovation, our initiatives catalyse transformativeimprovements across the health ecosystem.*Includes participants attending more than one module 4
EXCELLENCEOUR PEOPLEIMPACTOUR PURPOSECOLLABORATONOUR PARTNERS5
Powered by a community of professionals and experts committed to regulatory excellence andbetter health outcomes, our team brings together diverse knowledge, skills, and experience todrive innovation, collaboration, and practical solutions in healthcare regulation.OUR PEOPLE6
A capacity-building centre, offeringa comprehensive suite ofprogrammes delivered by leadingglobal experts.OUR PURPOSEShaping regulatory excellence across Asia-Pacific, our Centre has grown into a distinctorganisation with a threefold mission encompassing education, think tank initatives, and thoughtleadership. Through this integrated approach, we have become a global reference point forregulatory capacity building, policy innovation and a trusted advisory partner while continuing toadvance our vision to enhance regulatory capability and scientific excellence for health systemsand services.Education Experience Think Tank InitiativesThought LeadershipPerspectivesA think tank providing evidencebased insights that support informeddecision-making across diversedomains.A trusted advisory partner togovernments, regulators, and industrystakeholders through a robustinternational network.7
EDUCATIONEXPERIENCEAdvancing Capacity Building
“At the heart of CoRE’s impact is its educationarm, shaping the next generation of regulatoryleaders across Asia-Pacific.By equipping professionals with the knowledge,skills, and confidence to navigate evolvingregulatory landscapes, we are building afoundation for sustainable impact not onlywithin institutions, but across the wider healthecosystem.”— Professor Silke Vogel,Senior Advisor, CoRE9
CORE EDUCATIONPROGRAMMESOur education platform has become a cornerstone for developingskilled regulatory professionals, fostering knowledge exchange andsupporting health products innovation across the region.From the Graduate Certificate in Pharmaceutical Regulation to therecently launched Graduate Certificate in Medical TechnologyRegulation, as well as a suite of specialised and bespoke workshops, oureducation portfolio provides pathways for continuous learning andprofessional development.Accessible | Self-paced | Career-advancingEXECUTIVECERTIFICATEONLINEPROGRAMMESIN-COUNTRYAND BESPOKEWORKSHOPSGRADUATECERTIFICATES10
OUR IMPACT THROUGH EDUCATIONThrough a carefully designed portfolio that blendsacademic rigour with practical application, we equipprofessionals to meet the evolving demands ofregulation in a rapidly changing healthcare landscape.KEY ACHIEVEMENTS:A portfolio that developspractical regulatory skillsthrough team-basedlearning and casedriven exercisesA flexible curriculumthat adapts to emergingtopics such as digitalhealth, artificialintelligence, real-worlddata, vaccines and patientengagementAn integration ofexpertise fromregulatory authorities andindustry leaders to delivervalue-added knowledgeapplicable to real-lifescenariosA growing suite ofvirtual and in-persontraining offerings,enabling access to aglobal audience11
THINK TANKINITIATIVESStrengthening Health Systems
“CoRE is a unique and essential entity, helping ensure that science and innovation translate intoproducts that matter for people — influencing policy and strengthening health systems.”— Dr Margaret Hamburg, CoRE ChairpersonFormer US FDA CommissionerCoRE 10 Anniversary Celebratory Noteth
Through the ongoing strategic alliance between the Singapore MOH’s Health Regulation Group(HRG) and CoRE, we advance regulatory science, policy innovation, and system-level improvementsacross healthcare services and products. Working with a diverse network of internationalstakeholders, including the APAC Network of Healthcare Services Regulators, our RegulatoryAdvisory Panel, and the European Partnership for Supervisory Organisations (EPSO), wepromote regulatory excellence, transparency, and convergence across the region. Our currentpriorities focus on horizon scanning and building a repository of best practices in areas such as digitalhealth and artificial intelligence (AI), precision medicine and genetic testing, human biomedicalresearch, and outcome-based regulation, strengthening Singapore’s role as a regional leader infuture-ready healthcare regulation. With the consolidation of health services regulation and healthproducts regulation under HSA, we will continue to serve as a key academic regulatory partnersupporting both HSA and MOH.Health Regulation ProjectsRegulatory Systems StrengtheningThrough our think tank activities, we support regulatory system strengthening by working with arange of international partners to enhance capacity and leadership in health regulation.Commissioned by organisations such as the Gates Foundation, we support initiatives that expandaccess to quality and innovative diagnostics for global health needs. Through collaborations with theWHO and other stakeholders, we have advanced good regulatory practices and supported thedevelopment of digital health policy frameworks, ensuring that innovation remains aligned withpublic health priorities. Through partnerships with the ADB and other regional bodies, westrengthened regulatory resilience across developing member countries, promoting principles ofcollaboration, trust, and evidence-informed decision-making. Together, these efforts reflect our roleas a regional catalyst, building technical capacity while fostering responsible and effective healthregulation.Driving evidence-based regulation, shaping health policy,and enhancing the effectiveness of health systems acrossAsia, we at CoRE advance our think-tank and policyleadership activities as a core pillar of our mission.Through collaborations with partners such as Singapore’sMinistry of Health (MOH), the Health SciencesAuthority (HSA), the Gates Foundation, the AsianDevelopment Bank (ADB), the World HealthOrganization (WHO) and the International Council forHarmonisation, we have built a trusted platform for policydialogue and systems development. Through our research,partnerships, expert convenings, and advisory engagements,we support policymaking and contribute to the evolution ofregulatory frameworks in Singapore and across the region.Across these initiatives, we bridge regulatory practice andpolicy while promoting good governance, transparency andcollaboration across diverse healthcare domains.Standards Development Organisation (SDO)Appointed by Enterprise Singapore, CoRE-SDO spearheads the creation and promotion ofSingapore Standards that set the benchmark for biomedical and healthcare excellence.By supporting the Biomedical and Health Standards Committee and its technical groups, we advancecritical standards that position Singapore as a world-class biomedical hub, aligning with nationalpriorities such as Industry Transformation Maps and emerging areas in the RIE2025 plan, includingPrecision Medicine and AI in Healthcare.CoRE Think Tank14
“CoRE has been a valued partner in ourtransformation journey — providingexpertise, stakeholder engagement, andinnovative solutions that enhance ourregulatory standards while fosteringhealthcare innovation.”— Adj Professor Dr Raymond ChuaCEO, Health Sciences AuthorityDeputy Director-GeneralHealth Regulation GroupMinistry of Health, SingaporeCoRE’s 2024 Scientific Conference10 Anniversary Celebrations th15
HEALTH REGULATION PROJECTOver the past year, CoRE’s Health Regulation Project hascontinued to strengthen Singapore’s regulatoryecosystem by deepening research, broadening regionalcollaboration, and supporting policy development onemerging health technologies.To address the accelerating pace of AI innovation in healthcare, the team convened the third in a series ofclosed-door AI roundtables, focusing on operationalizing the AI in Healthcare Guidelines (AIHGLe)Version 2.0 for smaller, lower-resourced healthcare organisations. The aim was to develop a practicalbest-practices toolkit to support safe and sustainable AI adoption across the full AI lifecycle. Building oninsights from the first two roundtables in 2024 which established a shared understanding of AIgovernance challenges and translated principles into actionable frameworks, this discussionconcentrated specifically on implementation in resource-constrained settings.To enhance expert advice for the MOH, CoRE identified and convened a Regulatory Advisory Panel(RAP) comprising senior experts across multiple domains, such as Regulatory Transformation, DigitalHealth, Precision Medicine, Traditional Chinese Medicine, and Longevity Science. The RAP meetingsenable strategic discussion and provide guidance on emerging regulatory challenges andopportunities.In support of Singapore’s evolving regulatory architecture, the team also contributed to key policydevelopment efforts. This includes assisting MOH in drafting updated chapters on Genomics andGenetic Testing and Research, modernising the 2005 guidance to reflect advancements insequencing technologies, clinical interpretation, and data stewardship.At the regional level, CoRE contributed to the APAC Network of Healthcare Regulators by building acomprehensive repository of healthcare-related legislation, regulations, and guidelines across theregion. This growing resource supports cross-jurisdictional learning and fosters a more aligned,coherent regulatory landscape.The team additionally conducted background research into the Human Biomedical Research Act(HBRA), focusing on its scope, tissue banking considerations, and the patient consent process forresearch.Finally, the project analysed the deployment of outcome-based regulations under the HealthcareServices Act (HCSA), evaluating their current extent of use in Singapore and exploring how suchapproaches could be further leveraged to enable innovation while maintaining public safety.16
REGULATORY SYSTEM STRENGTHENINGPROJECT COMMISSIONED BY THEGATES FOUNDATIONOur Centre and the Duke Kunshan University embarked on a newlyestablished project on Enabling Access To In-Vitro Diagnostics forGlobal Health Needs, titled the CREATInG Initiative. Commissionedby the Gates Foundation, this project aims to accelerate access to invitro diagnostics (IVDs) for critical global health needs.The programme strengthens regulatory systems and buildsexecutive leadership through international conferences, training, andcapacity-building activities, particularly targeting low- and middleincome countries. By convening global and regional experts, industryleaders, and manufacturers, this initiative addresses both regulatoryand non-regulatory barriers to market access, promotes alignmentwith global standards, and enhances the efficiency of approvals.Early achievements include fostering strategic leadership, advancingregulatory functional skills among IVD manufacturers, andcontributing to more resilient and equitable health systems in theAsia-Pacific region.17
Standards Development Organisation2025 was a landmark year for us at CoRE-SDO, cementing Singapore’s leadership in biomedical and healthcare standardisation. Wedelivered 15 standard publications, including six in emerging domains such as Precision Medicine and Artificial Intelligence, advancing innovation and regulatory excellence across the ecosystem. Our influence extended globally with Singapore’s first proposedinternational biomedical standard for NGS-based oncology applications, formally endorsed at the ISO TC 212 meeting hosted inSingapore.By launching two transformative digital health standards—SS 719:2025 and SS 720:2025— we laid the foundation for patient datainteroperability and remote clinical monitoring, celebrated with a high-profile event attended by over 120 industry leaders. Beyondthese technical milestones, we strengthened public health with four impactful national standards on biosafety, infection control,supplement quality and medication delivery, engaging more than 230 participants through dynamic workshops. With over 500organisations influenced, 200 new partners onboarded, and a KPI compliance rate exceeding 100%, our CoRE-SDO team has not onlymet but surpassed expectations, positioning Singapore as a global reference point for health and biomedical standards.18
THOUGHT LEADERSHIPPERSPECTIVESPromoting Policy Innovation
“ Over the past decade, CoRE has played a crucial role inshaping the future of healthcare regulation, not just inSingapore, but across the region and beyond.As a hub for education, research and collaboration inregulatory science, CoRE has been instrumental inbuilding knowledge and skills necessary to navigate theincreasingly complex regulatory landscape.Through hard work and perseverance, CoRE hasbecome a beacon of excellence in regulatory science,fostering collaboration to address the challenges weface in the regulatory ecosystem. “P R O F K E N N E T H M A KD i r e c t o r - G e n e r a l o f H e a l t hM i n i s t r y o f H e a l t hS i n g a p o r eW e l c o m e s p e e c h a t C o R E ’ s 2 0 2 41 0 A n n i v e r s a r y N e t w o r k i n g D i n n e r &G r a d u a t i o n C e r e m o n yt h20
Advancing thought leadership in regulatory science and health policy, ourCentre leverages on a range of initiatives that convene experts, challengeassumptions, and shape new directions for the region. These platformsprovide trusted spaces for dialogue and insight, where regulators,policymakers, academics, and industry leaders exchange ideas and co-createsolutions to complex healthcare challenges.Major Initiatives:Sir Alasdair Breckenridge LectureAn inspiring evening of thought leadership and celebration featuredProfessor James Kingsland, OBE, University of Lancashire and Chair of theUK’s Digital Clinical Excellence Forum, delivering a compelling address titled“From Setbacks to Breakthroughs: The Development of Smart HealthcareRegulations,” with Professor Kenneth Mak, Singapore’s Director-General ofHealth, gracing the occasion as Guest-of-Honour. The event also celebratedthe CoRE Graduate Certificate Achievers and brought together professionalsand practitioners dedicated to advancing excellence in health regulation.CoRE ConversationFeaturing Dr Yasuhiro Fujiwara, Chief Executive of Japan’s PMDA and ViceChair of ICMRA, the CoRE Conversation highlighted his leadership, definingcareer moments, and regulatory stewardship, tracing his journey fromclinician and cancer researcher to national policy shaper and globalregulatory leader.Research and Policy CollaborationsThese collaboration advance work on digital health regulation, healthcareservices oversight, vaccine development, manufacturing and equitableaccess, horizon scanning, and emerging issues such as human challengestudies by offering evidence-based insights to anticipate regulatory trendsand facilitate innovation responsibly.Through these collective efforts, CoRE has cemented its reputation as atrusted policy partner and thought leader - informing national and regionalregulatory frameworks.21
OUR PARTNERSStrengthening regulatory partnerships, CoRE’s influence extends well beyond Singapore through sustainedcollaborations with leading organisations across the Asia-Pacific and globally. These collaborations reinforce ourrole as a trusted partner in advancing regulatory systems, governance, and regulatory science.22
HIGHLIGHTED PARTNERSHIPS ANDENGAGEMENTSRegional footprintacross more than 20economies inAsia-PacificMultiple jointinitiativeswith WHO, ADB, GatesFoundation and otherinternational partnersadvancing regulatoryexcellenceConsistentrecognitionfrom policymakers andindustry leaders forshaping the regulatoryscience ecosystemDriving impactful partnerships across regions, CoRE engaged the DNV Board on balancingregulatory rigour with innovation and explored collaboration opportunities in AI-enabledhealth technologies, adaptive clinical trials, and real-world evidence. Internationally, CoREheld a regulatory dialogue with European Medicines Agency Executive Director Ms EmerCooke on regulatory agility, scientific innovation, and international cooperation.Regionally, CoRE strengthened partnerships with Hong Kong SAR through discussions withthe Secretary for Health, Prof Lo Chung-Mau, focusing on regulatory convergence, capacitybuilding, and workforce development. Expanding collaboration across the Asia-Pacific, CoREparticipated in the 2025 APAC Health and Life Sciences Summit – Spotlight Indonesia,highlighting opportunities for cross-sector collaboration in the region’s evolving health andlife sciences landscape.WHY IT MATTERSThese engagements underscore CoRE’s role as a catalyst for excellence and a trustedconvener, connecting expertise across borders, disciplines, and institutions, and fosteringpartnerships that enhance regulatory capacity and drive innovation in health systems.23
Ms Emer CookeExecutive DirectorEuropean Medicines AgencyDr Lisa OoiAssistant Chief ExecutiveBiomedical Research CouncilA*STARMr Alok MishraCEOValue AdditionMr Jeffrey FrancerVice PresidentHead of Global RegulatoryPolicy and StrategyEli Lilly and CompanyADVISORY BOARDWe are delighted to welcome our new Advisory Board members, who join our globally recognised and visionary Boardmembers in advancing CoRE’s mission. Together, their expertise will further strengthen regulatory capability and scientificexcellence for health products and systems across Asia and the Pacific.ChairDr Margaret HamburgFormer CommissionerU.S Food and Drug AdministrationMembersDr Yasuhiro FujiwaraChief Executive Pharmaceutical andMedical Devices AgencyJapanAdj Prof Raymond ChuaChief Executive Officer, Health Sciences Authority,Deputy Director - General of HealthHealth RegulationMinistry of Health, SingaporeAdj Prof John SkerrittFormer Deputy SecretaryHealth Products RegulationAustraliaDepartment of Health and Aged CareProf James Kingsland, OBEChairpersonDigital Clinical ExcellenceForum (DiCE)Dr Peter HonigManaging DirectorBlackstone Life ServicesBoard MemberSesen Bio24
Thank youWe extend our heartfelt appreciation to our former Advisory Boardmembers for their years of service, leadership and commitment,which have been instrumental in advancing CoRE’s excellence,impact and partnerships.Dr Mimi ChoongFormer Chief Executive OfficerHealth Sciences AuthoritySingaporeProf Guido RasiFormer Executive DirectorEuropean Medicines AgencyDr Joseph Schreen FounderScheeren HealthCare LLCSpecial AdvisorFormer President andChief Executive OfficerCritical Path Institute (C-Path)Mr Michael GroppFormer ChairRAPSGlobal Advisory Council25
4 PHARMACEUTICALGRADUATE CERTIFICATECOURSES4 MEDICAL TECHNOLOGYGRADUATE CERTIFICATECOURSESUPCOMING 2026 EVENTSEXECUTIVE CERTIFICATECOURSEAPAC NETWORK ROUNDTABLE BESPOKE GATES FUNCTIONALTRAININGGOOD MANUFACTURING ANDLABORATORY PRACTICESWORKSHOPEPSO CONFERENCE REGULATORY ADVISORYPANEL MEETINGBuilding on a year of strong momentum and tangibleimpact, we enter 2026 with an ambitious slate of initiativesand events designed to expand learning opportunities,deepen collaboration, and amplify policy impact acrossAsia-Pacific.In doing so, we continue to advance our mission tostrengthen regulatory systems, inform policymaking, andpromote regional convergence.APEC RHSC CENTRE OFEXCELLENCE WORKSHOPClinical Development andEvaluation of AdvancedTherapies31st ISO/TC 212 Conference:Medical laboratories and invitro diagnostic systems26
DEAN THOMAS COFFMANThis year marks Professor Thomas Coffman’s retirement as Dean ofDuke-NUS Medical School. Over the past decade, his vision, guidance,and steadfast support have been integral to CoRE’s growth from a boldidea into a thriving Centre of excellence in regulatory science.Under his leadership, CoRE has leveraged its unique position as Asia’sfirst dedicated academic Centre for regulatory science, combining deepregulatory expertise, a wide Asia-Pacific network, and a commitmentto innovation. We are profoundly grateful for his transformative impacton Duke-NUS and CoRE.In appreciation ofThis short commemorative video celebrates DeanCoffman’s remarkable leadership27
PROF SILKE VOGELWe extend our heartfelt appreciation to Professor Silke Vogel for adecade of dedicated service as Deputy Director. She has played animportant role in building ur work within the regulatory ecosystemand ensuring the Centre’s impact.We are equally pleased to celebrate Professor Vogel’s appointmentas the inaugural Vice-Dean of the Office of Faculty Affairs at DukeNUS. With this new responsibility, she relinquishes her role asDeputy Director at CoRE and continues to support us in an advisorycapacity.Warm congratulations to Professor Vogel and we wish her everysuccess as she embarks on her new leadership role in Duke-NUS.Thank you& Congratulations28
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