MedTech industry has become significantly more complex and diverse with the arrival and addition of new technologies. This poses formidable challenges to the regulatory authorities to be constantly equipped with the required expertise to assess and regulate each of these different technologies.
The MedTech regulatory systems have seen a paradigm shift which presents an opportunity to bridge the growing gap between quality, safety and efficacy, and access through cooperation and capacity building.
There is also a need for better access to innovative technologies, best highlighted during the recent pandemic where regulatory authorities are required to be more agile and rely on their successful counterparts to expedite access to essential medical technologies.
Regulatory Transformation Symposium is an amalgamation of two key strategic concepts:
1. Showcase regulatory reliance as a pragmatic and effective tool to accelerate patient access to medical devices without compromising on safety and performance of the product.
2. Highlight effective deployment of Capability and Capacity building to build a robust, future-ready MedTech workforce.
Regulatory reliance partners, Singapore Health Sciences Authority (HSA) and Thai Food and Drug Administration (Thai FDA), share the key achievements and takeaways from their successful regulatory reliance project.
Hear from other agencies such as Philippines FDA, USFDA and many more who have adopted regulatory reliance and have begun to see its benefits.
Developed through sound fundamentals and dynamic research process, Regulators Curriculum White Paper provides latest insights and recommendations on the knowledge gaps, future trends, topics and comprehensive course outlines and learning objectives for regulators.
Through this Report, ASEAN markets have been studied in detail through advanced qualitative and quantitative research methods.
GHWP along with APACMed envisages to present an impartial view of the benefits of regulatory reliance and create awareness in APAC so that more jurisdictions will join the regulatory reliance bandwagon.
Launch and Presentation of Regulators Curriculum White Paper
Presentation of APACMed e-Learning Hub
Launch & Presentation of Regulatory Reliance Assessment Report
Case Study Presentations
Vote of Thanks
Lance Little became the Managing Director, Region Asia Pacific for Roche Diagnostics in 2012. Prior to that, he was the Managing Director of Roche Diagnostics India (including the Indian sub-region). His experience as Managing Director extends to both Roche Diagnostics Thailand and Roche Diagnostics New Zealand.
Lance joined Roche in New Zealand in 1995 in the technical support and management division of Boehringer Mannheim’s Clinical Chemistry portfolio, before moving on to sales and marketing roles. He was appointed Managing Director of Roche Diagnostics Thailand in 2008 before returning to New Zealand to take up the role of Managing Director in 2009.
Lance started his career as a Medical Laboratory Scientist, specializing in Biochemistry at Auckland Hospital Laboratory in New Zealand. Following that, he spent some time managing the Automation Laboratory at Diagnostic Laboratories in Auckland.
Dr Adelheid Schneider earned her Doctor of Science in cell biology and immunology from the University of Hohenheim/Germany and the Fraunhofer-Institute for Surface Technology.
With a background of biotechnology and cell biology Adelheid joined Roche in 1995. Within Roche, she worked in the field of research and development in protein chemistry and enzymology, quality assurance, quality control, documentation and regulatory affairs operation and policy. Adelheid is currently based in Singapore as Regional Head for Regulatory and Quality for Roche Diagnostics and has oversight of all outreach activities with global health authorities, industry associations and scientific organizations.
Dr. Schneider has
– 25+ years working experience in the healthcare and life science industry globally
– Solid scientific, regulatory and quality background
– Extensive experience working with global regulatory agencies to support development and resolution of complex regulatory situations
– is a successful leader in supporting product regulatory clearances globally
Dr. Schneider is the Vice Chair of APAC Med Regulatory Affairs Committee and Sponsor of Capacity Building and IVD working group. She is also an active member of APAC Med Regulatory Intelligence Group and the SEA Center of Excellence group. . Recently Dr. Schneider was appointed as Visiting Expert of the Duke Core Centre of Regulatory Excellence. Additionally she is leading several projects in the AHWP/GHWP IVD working group 2.
Miang is a Pharmacist, MBA. She has more than 25 years of regulatory affairs experience with numbers of Medical devices and Pharmaceutical companies. Her current position at Cardinal Health is the Regional head of Commercial quality and Regulatory Affairs, Asia Pacific.
Miang has a board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific including Japan. Prior to Cardinal Health, Miang worked for numbers of healthcare companies (Takeda, Boston Scientific, JNJ, Actelion, Cochlear, Bausch & Lomb, Zimmer Biomet and Alcon) in different locations (Bangkok, Hong Kong, Sydney and Singapore). In addition to her current job, she has been heavily involved with numbers of harmonization activities including GHTF, AHWP, APEC RHSC and ACCSQ. She was one of the members of GHTF SG02 (Postmarket Surveillance) and Co-chair of AHWP TC 2 terms.
Currently, she is a chair of APACMED Regulatory Affairs group and an industry secretariat of AHWP TC.
Mrs. Agnes Sitta Kijo, is a Pharmacist and holds a Master of Science (MSc) in Pharmaceutical Technology. She has over 21 years of experience in regulation of medicines and medical devices including in vitro diagnostics at the national and and international level.
She is currently working as a a Technical Officer, at the Facilitated Products Introduction (FPI) Team in WHO-HQ, Geneva, Switzerland. She is responsible for the Collaborative Registration Procedure for in vitro diagnostics and medical devices.
Mrs. Kijo has an extensive experience in medical devices regulation and regulatory harmonization initiatives for medical devices. During her career she held different technical, advisory and leadership roles which allow her to provide sound and relevant guidance/advice to regulators and regional harmonization initiatives globally. Mrs. Kijo was previously the Manager for medical devices registration in Tanzania and the first Chair of the African Medical Devices Forum (AMDF). It was during that time when major milestones were recorded. Her recent experience with the Collaborative Registration Procedure (CRP) has equipped her with knowledge and skills on how to guide countries in the implementation of the reliance concept.
Debmalya is a Managing Director in Accenture’s Life Sciences practice and leads the Medical Technology sector out of Accenture’s Singapore office.
He has over 18 years of consulting experience in the Life Sciences sector. His experience spans across multiple areas such as supply chain and manufacturing operations, business model transformations and market entry and commercial excellence. In his current role, Debmalya is leading discussions with global and regional medical technology companies in APAC on digital transformation enabled growth strategies focused on supply chain, distribution and customer excellence. Debmalya also works regularly with APACMed on industry topics such as regulatory capability building and cyber-security of connected Medical Devices.
Prior to consulting, Debmalya worked with J&J Medical in US and India with responsibilities in Supply Chain and Commercial Operations.
Debmalya has an MBA from Kellogg School of Management.
A seasoned management executive and astute medical professional, offering 22+ years of excellence in hospital management, comprehensive regulatory compliance and medical technology. Proffering expert advice and detailed clinical engineering strategies for high-end projects, including protocol development, study design, regulatory strategy and submission and study execution strategies.
Initiated savings of SR multimillions through efficient purchasing of medical equipment as Director of Clinical Engineering.
My extensive experience leading international work groups as Chair of Global Harmonization Working Party Technical Committee (GHWP- TC) and then elected as Chair of Global Harmonization Working Party (GHWP) that has equipped me to professionally approach multi-cultural institutions and associations to improve their processes and procedures, manufacturing technology, quality management, regulatory requirements. Additionally, I have been involved internationally in the industry of medical device technology with knowledge of IVD regulations and lead Medical Devices harmonization and convergence approach internationally.
Mr Dalaan currently holds the position of Vice Executive president, Medical Devices in Saudi FDA. The Saudi Food and Drug Authority (SFDA) is an independent body corporate that directly reports to The President of Council of Ministers. Its objective is to ensure safety of food and drug for man & animal, and safety of biological & chemical substance as well as electronic products. He is also the Chair at Global Harmonization Working Party (GHWP). GHWP is a non-profit organization, its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions.
Professor John CW Lim is founding Executive Director of the Centre of Regulatory Excellence (CoRE) at the Duke-National University of Singapore Medical School (Duke-NUS), inaugural Chairman of the Consortium for Clinical Research & Innovation Singapore (CRIS), Senior Advisor at Singapore’s Ministry of Health (MOH), and Policy Core Lead at the SingHealth Duke-NUS Global Health Institute (SDGHI). He is Professor of Practice at Duke-NUS and the NUS Saw Swee Hock School of Public Health.
Formerly Chief Executive Officer of Singapore’s Health Sciences Authority and Deputy Director of Medical Services (Industry & Research Matters) in MOH, Professor Lim has also held other senior positions in Singapore’s Health and Education ministries. His current roles promote capacity building and scientific excellence for health products regulation, health policies and systems in Southeast Asia and the Asia-Pacific.
Professor Lim is a member of the Singapore Food Agency Board, APEC Life Sciences Innovation Forum’s Executive Board, Davos Alzheimer’s Collaborative Leadership Group, US Pharmacopoeia (USP) Council of the Convention as Asia-Pacific Chapter Chair, USP Quality Institute’s Advisory Group, Centre for Innovation in Regulatory Science’s Scientific Advisory Council, and St Andrew’s Mission Hospital Board.
In 2018, Professor Lim received the Drug Information Association’s Global Connector Inspire Award for leadership in promoting global collaboration to advance healthcare products to patients, and the Regulatory Affairs Professional Society’s highest Founder’s Award recognising substantial sustained impact in shaping regulatory practice and policy over the course of his career.
Ms Salbiah Yaakop has more than 30 years of working experience, and is currently the Director of Policy, International Affairs and Industry Facilitation Division of the Medical Device Authority, Ministry of Health Malaysia. Here, her main functions are development of policies; regulatory documents; guidance documents and guidelines; managing international affairs and inter-agency agenda; industry facilitation; events and specific projects; performing registration and licensing evaluations and verifications; and giving trainings and consultancy. She often represents MDA in other government and non-government meetings and programs and initiatives.
She is currently the Global Harmonization Working Party (GHWP) Technical Committee Chair, GHWP Working Group 8 Chair on Standards for Medical Devices, Convener for ISO/TC 210/WG 7 on Good Engineering Maintenance Management, and Chairperson of various Guidance Document Development Committees in the Medical Device Authority. She is also a member of various National Standards Committees, Technical Committees and Working Groups related to medical devices in the national standards system.
Prior to her current field of work, she has almost 10 years of working experience in the automotive industry, working in the fields of mechanical, industrial and process engineering, and procurement.
Ms Salbiah Yaakop graduated with a BSc in Biomedical Engineering from Marquette University, USA.
Bryan So is the Managing Director, Business Development of the Multi-Scale Medical Robotics Center Limited under The Chinese University of Hong Kong (CUHK). He is the Senior Manager of the Chow Yuk Ho Technology Centre for Innovative Medicine, Faculty of Medicine, CUHK which aims to improve clinical care for patients through innovation and development by interdisciplinary collaboration of engineering and medicine as well as the transfer of medical technologies into clinical practice. Prior to joining CUHK Medicine, Bryan was the Deputy General Manager and Principal Consultant of the Hong Kong Productivity Council, responsible for medical technology development, precision machining, advanced optics and smart health business. As a Registered Professional Engineer & Adjunct Associate Professor in biomedical engineering, Bryan served as co-principal investigator and investigator in various Medtech R&D projects, covering the sub-specialties of orthopedics, dermatology, prosthodontic and surgery, through Innovation Technology Fund of the Hong Kong SAR government and industrial funding.
As a pioneer in technology R&D, Bryan has won various recognitions & awards, including the Grand Prize of the Hong Kong Institution of Engineers (HKIE) Young Engineer of the Year Award, Grand Prize of HKIE Innovation Awards for Young Members; HKPC Award for Distinguished Achievement, Most Valuable Person, Outstanding Supervisor; Gold Medals with Congratulations of Jury in the International Exhibition of Inventions Geneva in 2017 and 2018.
Bryan is a consultant in ISO13485 and GMP, highly experienced in medical device quality management, risk management systems and regulatory affairs consultancy. He has served the Global Harmonization Working Party (GHWP) [formerly AHWP] since 2008 and currently serves as the Executive Secretary General of GHWP to facilitate the medical device regulatory convergence for 32 member countries and regions. As an expert in medicinal product regulations, Bryan has developed the pilot schemes of medical device risk management & pharmaceutical product good distribution practice in Hong Kong.
With over 20 years of professional experience in technology R&D, engineering, and consultancy in senior executive positions, Bryan has strong network with the industries and professional sectors. Bryan is the Founding Committee Member of the Engineering in Medicine & Biology Society-HK-Macau Joint Chapter, The Institute of Electrical and Electronics Engineers (IEEE EMBS), he also served in the Advisory Peer Group and Departmental Advisory Committee in the universities in Hong Kong. Bryan has built the industry best practices and enabled the technology upgrade for various industry sectors, including electronics, opto-mechatronics, critical components and the medical & healthcare device industries through BUD and SME development funds. Bryan is a professional assessor of Biomedical Discipline, and member of the Biomedical Discipline Advisory Panel of HKIE; he is the led in promoting professional upgrade for biomedical engineering, pediatric dermatology, optical engineering through various support funds of the HKSAR government.
Bryan obtained his Bachelor of Engineering with honors in Mechanical and Automation Engineering, minor in Computer Science from the Chinese University of Hong Kong (CUHK); Master of Science in Engineering in Industrial Engineering and Engineering Management from the University of Hong Kong (HKU); and completed the Consortium Program under the School of Business and Management of the Hong Kong University of Science and Technology (HKUST).
Kazuhisa Senshu assumed the position of CRAO (Chief Clinical and Regulatory Affairs Officer) in 2017. In 2015, he was assigned as a general manager of clinical and regulatory affairs as global HQ function in Japan. From 2009 to 2015, he worked in Terumo Europe located in Leuven, Belgium as scientific and clinical manager to execute clinical investigations in Europe and/or global for the purpose of regulatory approval in Japan. CE marking was one of his educational program during this period.
Hiiti Sillo is the current Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until late 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS) within the Regulation and Safety Unit. In his current capacity, he is responsible for coordinating WHO strategies for strengthening national and regional regulatory capacities, promoting regulatory networks, convergence, work-sharing and reliance as well as strengthening safety monitoring and addressing the global problem of substandard and falsified medical products.
Before joining WHO in 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA), the position he held since 2010 after serving on several technical and managerial positions within the TFDA and its predecessor, the Pharmacy Board of Tanzania. He also championed regulatory harmonization initiatives in Africa and particularly the launch of the African Medicines Regulatory Harmonization (AMRH) for the East African Community, the AMRH show-case.
Mr Sillo is a Pharmacist and holds Master of Science in Pharmaceutical Services and Medicines Control.
Michael Flood began his career in medical devices in the late seventies with qualifications in Engineering.
Over in excess of forty years, he has work in all facets of the medical devices industry, within manufacturing, health care delivery, regulation of medical devices and now acts as a consultant to all three sectors.
He is –
Tracey Duffy is the First Assistant Secretary of the Medical Devices and Product Quality Division in the Therapeutic Goods Administration (TGA). The TGA is part of the Australian Government Department of Health. Her Division’s responsibilities include medical device regulation, good manufacturing practice and laboratory testing. Tracey has held a number of senior policy, program and regulatory roles within the Department of Health.
Dr Rama is the Director, Medical Devices Branch, Health Sciences Authority (HSA). She oversees the pre-market registration and the post-market controls for medical devices in Singapore. She also oversees the device development consultation that aims to support safe innovation in medical technologies locally. She has been working in the area of Medical Device Regulations for over 12 years now.
Prior to joining the HSA, she was involved in Research on chronic pain and neuropathic pain at the National University of Singapore, identifying novel biomarkers related to pain and developing novel diagnostic methods using principles of chemistry in analysis of biological samples.
Dr Rama currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF).
She has been in the Pharmaceutical and Medical Device industry for over 20 years. She has held Asia Pacific regional positions in Pharma companies such as Eli Lilly & GSK and was the Director of Clinical & Regulatory Affairs at Johnson &Johnson Medical Asia Pacific, pioneering premarket registration work on breakthrough technology in Medical Device. She was the Vice President of Quality Assurance & Regulatory Affairs for Asia Pacific and Greater China regions at GE Healthcare serving combined business size of $3.6B and Vice President of Regulatory Affairs at APACMed, sitting at the table with government and policy makers, advocating for a significant number of global MNC and local SME. Prior to joining Baxter, she was the Vice President, Regulatory & Government Affairs and Quality Assurance at Align Technology, Asia Pacific. She has built the QA/RA/GA team of the first Greenfield manufacturing plant in Asia. Led the team in setting up QMS from ground up and successfully obtained the product registration approval within one year.
Quan is currently the Vice Chair of Global Harmonization Working Party, an organization of 32 member economies and regions of Regulators and Industry in Asia, Middle East, Africa, USA and South America. She also leads the GHWP Capacity Building initiatives contributing in the global effort of Medical Device Regulatory harmonization and convergence.
She holds a Master of Science in Clinical Pharmacy from The London School of Pharmacy, UK.
Mr Ahmad Shariff Hambali is the current Chief Executive of Medical Device Authority (MDA) Malaysia. He received his BSc (Physics) degree from University of Science Malaysia in 1988 and later Master of Medical Physics from University of Malaya in 2003. He joined the Malaysian government service in 1993 as an assistant director at the Engineering Services Division, Ministry of Health Malaysia. During his time at the Engineering Services Division, Ministry of Health Malaysia, Mr Ahmad was attached to the Radiation Health and Safety Unit which was entrusted to regulate radiation usage for medical purposes. Mr Ahmad was one of the pioneers, who has been very instrumental in the development of the medical device regulatory framework in Malaysia. The regulatory framework, which was based on international standards and best practices, was subsequently gazetted as the Medical Device Act in 2012. When MDA was established in 2013, Mr Ahmad was one of the pioneers who joined MDA to lead the Registration, Licensing & Enforcement Division at MDA before being appointed as Chief Executive of MDA in 2018.
Current Position : Director of Medical Devices Policy Division, Medical Devices Safety Bureau, Ministry of Food and Drug Safety
M.S.(1994.3~1996.2) : Master degree of Pharmacy, Chungnam National University
B.S.(1989.3 ~ 1994.2): Bachler degree of Manufacturing Pharmacy, Chungnam National University
2015 – 2022
Medical Device Evaluator,Ministry of Health, Indonesia
Scientific Communication Officer, PT. Dexa Medica
Indonesia University, Master of Public Health
Gadjah Mada University, Bachelor of Pharmacy
2019 Analysis of Preparedness for the Implementation of Simplified System and Permission Process in the Development of Medical Devices
2012 Immunomodulatory Effects of Hexane Insoluble Fraction of Ficus septica Burm. F. in Doxorubicin-treated Rats
Fikri is a Senior Medical Device Reviewer in the Ministry of Health of the Republic of Indonesia. After finished his Master of Public Health at The University of Melbourne under the Australia Awards Scholarship Program, he is now responsible for Medical Device Local Production Initiative in Indonesia as part of the Center for Health System and Strategies. With his extensive experiences in regulatory framework, policy and analysis, he spearheaded various health administrative initiatives through managing projects and performing analysis for improving health outcomes towards efficient health policies. He is keen for opportunities and further collaboration that will enhance the nation’s objectives and take his experience beyond academic and policy horizons to become future leaders who are needed in this society – Global Public Health Leader.
Harjit was appointed CEO of APACMed in February 2019. Founded in 2014, the Asia Pacific Medical Technology Association is the only regional association to provide a unified voice for the medical technology industry in Asia Pacific.
She was formerly EVP and CEO of Philips ASEAN & Pacific until October 2015. In this role, she managed a team of 10,000 people in 10 countries across its Healthcare, Lighting and Consumer Lifestyle sectors. Harjit spent over two decades with Philips holding a variety of international roles in General Management in England, Holland, Singapore, Dubai and Hong Kong.
Passionate about innovation and healthcare reform, she holds concurrent positions on several prestigious boards:
• Board Member, ResMed, a pioneer in cloud connected, innovative solutions, for people with sleep apnea, COPD, and other chronic respiratory diseases
• Board Member, MAS Holdings, South East Asia’s largest manufacturer of apparel and textiles
• Board Member, Apollo Education, a leading English Education provider in Vietnam
• Advisor, Delmedica, an innovative Singapore-based company that has developed the X-Halo, the world’s first breath thermometer for managing respiratory diseases.
She is a former Singapore Chapter Chair of the Young Presidents Organisation, the premier leadership organisation of Chief Executives in the world, and former Board member of the SICC, National University of Singapore Entrepreneurship Committee and World Economic Forum Global Agenda Council on South East Asia. Harjit has spoken at several global leadership platforms including the World Economic Forum, INSEAD and IMC on Innovation and Healthcare.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 75,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. bd.com
ConvaTec is a FTSE 250 global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care. We have more than 10,000 colleagues and sell our products and services in over 100 countries. Our vision is Pioneering trusted medical solutions to improve the lives we touch. Our products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. Group revenues in 2021 were over $2 billion.
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and a pioneer of robotic-assisted surgery. At Intuitive, our mission statement is we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures, and markets the da Vinci surgical system and the Ion endoluminal system.
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive and more personalized.
Roche established a presence in the Asia Pacific in 1925. Today, we operate in 16 locations across the Asia Pacific region from Pakistan to Australia and New Zealand, supported by more than 5,700 employees. With the industry’s most comprehensive diagnostics portfolio, we are committed to innovate diagnostics, shaping healthcare and changing lives. Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience.
Founded in 1921, Terumo has worked to rapidly bring medical settings the advanced products that they need, based on our unchanging group mission of “Contributing to Society through Healthcare.” Because of our strong desire to contribute to the advancement of healthcare—not only in Japan, but throughout the world—we have taken on the challenges of a variety of clinical environment to now do business in over 160 countries and regions.
Sponsors receive the exclusive opportunity to physically attend the Symposiums at our event venue.
For sponsorship opportunities, please contact Gabriel Sim.
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