Year in Review The best of 2022 featuring CoRE SCIENTIFIC CONFERENCE PATIENTS AS PARTNERS FOR HEALTH: CO-CREATING EQUITABLE ACCESS TO HEALTH PRODUCTS AND SERVICES SIR ALASDAIR BRECKENRIDGE LECTURE LAUNCH OF EXECUTIVE CERTIFICATE CoRE CONVERSATION WITH DR PETER HONIG MOU WITH CIOMS ..and more
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1 - Centre of Regulatory Excellence (CoRE) Message from Executive Director Professor John Lim Advisory Board and Leadership 2 - Education 10 12 14 16 18 20 22 3 - Think Tank 20 6 8 24 26 28 30 Strengthening Regulatory Systems Through Education Launch of Executive Certificate Graduate Certificate in Health Products Regulation Supporting Tomorrow’s Leaders Education in Numbers CoRE Conversation with Dr Peter Honig Thank you for your continued and unwavering support Sir Alasdair Breckenridge Lecture and Graduation Ceremony Accelerating Patient Engagement Collaboration with the Singapore Ministry of Health (MOH) Health Regulation Group (HRG) 32nd European Partnership Of Supervisory Organisations in Health Services and Social Care (EPSO) Conference Regulatory Approaches in Digital Health Health and Regulatory Systems Strengthening 22 4 - Partnership Memorandum of Understanding (MOU) with the Council for International Organizations of Medical Sciences (CIOMS) CoRE Campaign Opportunities to Collaborate in 2023 and Beyond International Partnerships 5 - People 32 34 36 38 40 42 44 46 48 50 52 54 59 Faculty Appointments Visiting Experts CoRE Team Contact Us Click to read 4 5 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
“Forward-looking” has been a resonating theme throughout this year in many of the dialogues CoRE and our stakeholders have had. As health services and health products innovation and associated regulation converge, the science and art of facilitating access to innovative technologies of good quality, safety, and efficacy in supportive health ecosystems have become more challenging and also exciting. In this increasingly complex and interconnected world, CoRE continues to serve as a neutral platform for stakeholder engagement for regulatory capacity building and policy innovation in AsiaPacific. CoRE has seen huge interest in better understanding and implanting good regulation from innovators, healthcare professionals, and policymakers. We must distil the successes the global regulatory community has achieved in the past few years, hard-earned and learned during the COVID-19 pandemic, and translate the key learning points to enhance regulation of rapidly developing areas that include digital health and advanced therapies. Executive Director CoRE Prof John Lim Core Lead (Policy) SingHealth Duke-NUS Global Health Institute Senior Advisor Ministry of Health, Singapore Chairman Consortium for Clinical Research & Innovation, Singapore (CRIS) We actively contributed our voice and perspectives on regulating innovative health products and health services to collectively address developments at local, regional and global platforms. This year, CoRE established new partnerships and strengthened existing ones. We began collaborating with the Health Regulation Group (HRG) of Singapore’s Ministry of Health (MOH) to promote best practices in healthcare services regulation across the region. As an initial step, CoRE co-hosted the 32nd European Partnership of Supervisory Organisations in Health Services and Social Care (EPSO) Conference with a focus on Asia-Pacific (APAC) this year. CoRE also signed a memorandum of understanding with the Council for International Organizations of Medical Sciences (CIOMS) to work together in mutual areas of interest. Other highlights of 2022 included hosting the CoRE Scientific Conference on the theme of “Patients as Partners for Health: Co-creating Equitable Access to Health Products and Services”. This brought together local and global partners of the Coalition to Accelerate Patient Engagement (CAPE) in Asia-Pacific to continue sharing patient engagement initiatives to help stakeholders adopt or adapt these in their respective patient engagement journeys. More than thirty speakers and two hundred participants in leadership roles from across eighteen economies attended the event, mainly in person. The conference concluded with a conference statement among the stakeholders to serve as a working document to clarify guiding principles to move APAC patient engagement forward. As we take stock of our many experiences from the past three pandemic years, we can appreciate that we have all been changed at individual, organisational and societal levels in ways big and small as we move into the era of a new normal. Having successfully pivoted to delivering our educational and think-tank programmes virtually in 2020, we are now moving through a transitional hybrid phase back to predominantly in-person events in 2023. What has not changed and has in fact been strengthened is CoRE’s commitment to nurturing well-connected, future-ready regulatory professionals and providing thought leadership to stimulate enhanced health products and systems regulation and policy innovation in the years ahead. I hope you find this Annual Report an interesting read and I look forward to continuing our partnership in advocating and nurturing regulatory science excellence. 6 7 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
We would like to express our appreciation to the visionary members of our Advisory Board and our Special Advisors. Their strategic guidance and unceasing support have contributed significantly to CoRE’s vision, mission, and success. Dr Mimi Choong Prof Guido Rasi Dr Peter Honig Dr Joseph Scheeren Mr Michael Gropp Dr Paul Huckle Special Advisor Adj Prof John Skerritt Special Advisor Dr Yasuhiro Fujiwara Special Advisor Mr Jean-Luc Butel Chief Executive Officer Health Sciences Authority Singapore VISION Former Executive Director European Medicines Agency Board Member Sesen Bio Former Senior Vice President Global Regulatory Affairs Pfizer To be a leading Centre enhancing regulatory capability and scientific excellence for health products and systems in Asia. Chair Founder Scheeren HealthCare LLC Special Advisor, Former President & Chief Executive Officer Critical Path Institute (C-Path) Dr Margaret Hamburg Former Commissioner U.S. Food And Drug Administration MISSION Former Chair RAPS Global Advisory Council Former Chief Regulatory Officer & Senior Vice President GlaxoSmithKline To establish regional platforms and networks to grow competencies, enhance collaboration and promote thought leadership in innovative regulatory science and health policy. Deputy Secretary Health Products Regulation Australian Department of Health and Aged Care Chief Executive Pharmaceuticals and Medical Devices Agency Japan President K8 Global New Advisory Board Member Adj A/Prof Raymond Chua We are delighted to welcome Adjunct Associate Professor Raymond Chua as an Advisory Board member. Professor Chua began his medical career after graduating from the Faculty of Medicine at the National University of Singapore in 1997. He became certified as a Registered Public Health specialist and Fellow with the Academy of Medicine, Singapore in 2007. His career has spanned industry experience, Group Director of the Health Products Regulation Group (HPRG) at the Singapore Health Sciences Authority (HSA), and his current responsibilities as Deputy Director of Medical Services of the HRG at the MOH, Singapore. Deputy Director of Medical Services Health Regulation Group Assistant Commissioner Cybersecurity (Healthcare) Ministry of Health, Singapore 8 9 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
Strengthening Regulatory Systems Through Education Launch of Executive Certificate Graduate Certificate in Health Products Regulation Supporting Tomorrow’s Leaders Education in Numbers CoRE Conversation with Dr Peter Honig Click to read 10 11 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
" Asst Prof James Leong Head Health Products & Regulatory Science Centre of Regulatory Excellence Duke-NUS Medical School The COVID-19 pandemic highlighted the importance of preparedness in addressing public health needs and areas where system strengthening should be prioritised. As countries begin their journeys to living with COVID-19, it is now vital to review gaps in the regulatory systems that warrant our attention, especially those that had been side-lined by the pandemic in the past three years, and address these to better tackle future public health emergencies and equitable peacetime health access. The efforts to improve regulatory systems through education must be continual; it is an ongoing journey to facilitate good regulatory practices that marries science and regulations. Recognising the need for continuity in efforts toward stronger regulatory systems, CoRE continues to provide quality training accessible by regulatory professionals in ASEAN and Asia- Pacific. These courses address contemporary issues and levelling up of baseline competencies in regulatory decision-making. New online courses are being developed to complement and expand on the well-received existing offerings under our Graduate Certificate and new Executive Certificate programmes. " The current momentum to enhance healthcare systems has provided strategic platforms for CoRE to further engage regulatory authorities and industry organisations. We have sought a better understanding of training needs and forged partnerships to optimise the delivery and practical relevance of our education offerings. CoRE believes that our relentless approach and commitment to regulatory systems strengthening is a key tool to developing professionals and impacting patients for the better. 12 13 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
In expanding the options for individuals pursuing career development, CoRE launched two Executive Certificates in In Vitro Diagnostic Devices (IVD) and Software as Medical Devices (SaMD), in collaboration with Diagnostics Development Hub (DxD Hub) of Singapore’s Agency for Science, Technology and Research (A*STAR). These programmes consist of 2-day short courses to accommodate the schedules of working professionals. The Executive Certificates can also be stacked towards the Graduate Certificate, facilitating participants’ journey in their professional development. " Product Development and Manufacturing Regulation of IVD and SaMD With the projected sustained growth and increasing utilisation of IVD, many are interested in bringing their IVD innovations to the market. This course will highlight essential thought processes, considerations and insights for a successful translation of an IVD concept to a product launch. Dr Siti Sarah Daud Head Research & Development (R&D) Cell ID Pte Ltd Singapore Regulatory Requirements of IVD and SaMD Failure to meet regulatory requirements can be a significant barrier to timely access of healthcare products for patients. To help reduce the inadequacies of a regulatory submission, this course helps to acquaint participants of the regulatory requirements for market approvals of IVD and SaMD, and the principles behind the practices. The regulation of SaMD and IVD courses conducted by CoRE are indeed a valuable resource platform for industry professionals to increase knowledge on essential regulatory requirements and to obtain holistic reviews of interaction between key standards that help to address product development needs of connected medical devices. The case studies from both workshops are very effective, paired with guidance documents and the panel discussion has given me better perspective on the magnitude of change management challenges in IVD and medical device markets impacted by the new EU regulation. 14 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People " 15
The Graduate Certificate Programme was introduced to focus on end-to-end regulatory activities across the life cycle of healthcare products. Using this platform, CoRE increased the access to training materials to professionals to build a strong foundation in regulatory decision-making and obtain a formal academic certificate in recognition of their new competency. The courses cover both breadth and depth of regulatory requirements across the life cycle of a variety of health products encompassing pharmaceuticals, biotherapeutics, advanced therapies and medical devices. In particular, this year’s workshop for advanced therapies highlighted and supported the release of Singapore’s dedicated regulatory framework for cell, tissue and gene therapies. This forms part of the background for capacity-building in the ASEAN region, with these innovative therapies promising to become increasingly significant in the near future. Leveraging on the flexible approach for developing the curriculum, CoRE incorporated essential training elements with current issues faced in the regulatory environment. Topics like regulatory cooperation, lessons from the COVID-19 pandemic, evaluation of vaccines and IVD, have been included across workshops and deemed extremely valuable as part of training healthcare professionals for future outbreak preparedness. Our distinguished faculty and regulatory experts from across the globe have been instrumental in the success of the workshops, and have shared immensely valuable knowledge with the participants. Together with this growing pool of knowledge domain leaders and supportive participants, CoRE continues to fulfil our goals of building regulatory capacities in ASEAN and contributing to strengthening regulatory systems. 16 17 1 CoRE 2 Education 3 Think Tank 4 Partnership 5 People
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