Wong Woei Jiuang is the Acting Assistant Group Director of Medical Devices Cluster, Health Products Regulation Group of Health Sciences Authority (HSA). The Cluster is responsible for the pre and post market regulation of medical devices as well as the pre-market consultation scheme that supports innovation and device development by ensuring devices are in line with regulatory requirements. She currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF) and is also the Chair of the ASEAN Medical Device Committee. She is a member of the working group that developed the WHO Global Model Regulatory Framework for medical devices.

Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Margolis Center for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care including payment reform, real-world evidence and more effective drug and device innovation. He is former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the U.S. Food and Drug Administration, where he developed and implemented major reforms in health policy. He was previously Senior Fellow at the Brookings Institution and a faculty member at Stanford University.

Korrapat Trisarnsri is currently the Director of Medical Device Control Division at Thai Food and Drug Administration, with over 30 years’ in medical device regulation in Thailand.

She holds a Master of Public Health from the Mahidol University and a Bachelor of Pharmaceutical Sciences degree from Chulalongkorn University.

Previously, she served as head of the pre-market control group, responsible for overseeing product approval, advertising and export certificate. Moreover, she is also a MIS ADMIN, developing information systems for medical devices.

Ir. Sasikala Devi Thangavelu holds a MSc in Biomedical Engineering and she is currently the Director of Policy, Code & Standard Division, Medical Device Authority, Ministry of Health Malaysia. She has 16 years of working experience in the Ministry of Information and Ministry of Telecommunication, Malaysia. Her career in the healthcare sector started in the year 1999 as a project engineer of healthcare facilities, Engineering Services Division, Ministry of Health, Malaysia. Her active involvement in medical device regulatory affairs started with her appointment in the Medical Device Core Team in 2005 to develop the Medical Device Regulatory Program for Malaysia. She is a member of numerous committees in the Industry Standard Committee (ISCR) which is responsible in developing Standards for medical devices and facilities for healthcare in Malaysia. She is the Malaysian Technical Committee representative and Work Group member in AHWP and the country representative for ACCSQ-AMDC.

Lupi Trilaksono is currently the Deputy Director of C and D Class Medical Devices, Directorate of Medical Devices Evaluation, Directorate General of Pharmaceutical and Medical Device, Ministry of Health Republic of Indonesia.

Lupi is Pharmacist and hold Master of Management degree from Gadjah Mada University in Indonesia. He started his career at the provincial healthcare office at Riau Islands Province. During his appointment at the Directorate of Medical Device Evaluation Ministry of Health of Republic Indonesia, he was a Head of Section-Inspection for production and distribution facility, and Head of Section-Standardization and Certification of Medical Devices and Household Health Products.

Since then, he has been involved in the regulatory framework and policy of medical device in Indonesia and regional. He also active and represent Indonesia in the ASEAN Medical Device Committee and ASEAN Medical Device Technical Committee, and also active in Harmonization and Convergence of Medical Device works in Global and Regional forum of AHWP, APEC- RHSC, WHO dan IMDRF

Dr Sangjin Park is Scientific Reviewer of Cardiovascular Devices Division, which performs scientific review and approval for marketing authorization of cardiovascular devices. Dr Park started his career at Korea Food and Drug Safety(former MFDS) in 2010. After assuming scientific reviewer of various medical device evaluation division, he has been scientific reviewer of cardiovascular division since 2017.

Dr Park has extensive experiences and expertise in medical device evaluation and and review of testing methods, research on establishment of national reference standards for IVDs.

Dr. Yokoyama graduated from Kanagawa Institute of Technology with a master degree in mechanical engineering. He studied the hemodynamics in cerebral arteries. He changed subject of study to develop a left ventricular assist device at Tokyo Medical and Dental University. In 2011, he received Ph.D. in medical engineering. He worked in Laboratory of Bioengineering in Tokyo Medical and Dental University from 2008 to 2011．Since 2011, he worked as medical device reviewer in Pharmaceutical and Medical Devices Agency. He worked for IMDRF Regulated Product Submission Working group from 2013 to 2015. He moved to Office of International Cooperation in 2017 and mainly works for international affair related to medical device regulation.

Professor John CW Lim is founding Executive Director of the Duke-NUS Centre of Regulatory Excellence (CoRE), Senior Advisor at the Singapore Ministry of Health (MOH), and Chairman of the Singapore Clinical Research Institute and National Health Innovation Centre. He is Professor of Practice at the Duke-National University of Singapore Medical School and the NUS Saw Swee Hock School of Public Health. He was formerly Chief Executive Officer of Singapore’s Health Sciences Authority from 2006 to 2014, and has held senior positions in MOH and the Ministry of Education.

Professor Lim is a medical graduate of NUS with Masters degrees in Public Health from NUS and Health Policy and Management from Harvard University. He is a Specialist in Public Health Medicine and a Fellow of the Singapore Academy of Medicine.

In CoRE, Professor Lim draws on his international experience and networks to enhance health regulatory and systems capacity and scientific excellence for national authorities and industry in the Asia-Pacific and South-East Asia. He is a member of the Executive Board of the APEC Life Sciences Innovation Forum, the Advisory Group of the US Pharmacopoeia’s Quality Institute, the Scientific Advisory Council of the UK Centre for Innovation in Regulatory Science, and the Board of St Andrew’s Mission Hospital in Singapore. Professor Lim received the international Drug Information Association’s 2018 Global Connector Inspire Award for leadership in promoting global collaboration to advance healthcare products to patients.

MedTech Europe (2012 - ) – Medical Technologies
Currently and for the last 6 years – CEO MedTech Europe.
Medtech Europe is the European association which represents the interest of the MedTech Industry in Brussels (Staff of 45 people - dealing with Brussels – EU institutions and Health stakeholders) and in Europe through the network of over 45 National trade Associations all members of MedTech Europe. MedTech Europe is composed of Medical device companies, IVD companies, National Associations and others which individual associations merged in December 2016.

Medtronic (2007 – 2012) – Medical Devices
President Medtronic France and Vice President Medtronic Europe – (5 years) (Paris, France)
President of APIDIM (trade association of US MedTech Companies in France) and Vice-president / treasurer of SITEM (French trade Association of MedTech).

Schering Plough (1998 – 2007) - Pharma
Vice President, Middle East Africa – Schering Plough (Pharma) (5 Years) - (Dubai, UAE)
8 affiliates reported into the function.
Director, BU Respiratory, Schering -Plough France – 4 years (Exec. Committee)

Johnson & Johnson – 17 years (1981 – 1998) - Pharma
Janssen-Cilag – Paris (France) (4 years)
Lead integration of Cilag & Janssen in France, BU Director, Sales Administration & Training Director. (Exec. Committee)
Cilag International – Zurich (Switzerland) (3 years):
International Business Development Director (Derm/Gynecology Franchises)
Ortho Pharmaceuticals – Derm Division – US (11 years):
Sales Rep, Mkt Research, product manager, Regional Sales manager, Marketing Director.

Background
Paris Business School – MBA (Paris)
American Graduate School of International Management (Thunderbird) – MIM – (Phoenix, Arizona)
Marrried - 4 kids!

Dominik Reterski, is the Vice President of Quality & Regulatory Affairs Asia Pacific.
In this role, he oversees all Quality and Regulatory operations in the Asia Pacific region.

Dominik has also been an active leader in industry trade groups and had served previously as the Chairman of the Emerging Markets Group at the European Medical Technology Association MedTech Europe; Chairman of the Regulatory Affairs Committee at MECOMED, the Middle East Medical Devices & Diagnostics Trade Association and currently serves as the Chairman of the Regulatory Affairs Committee at APACMed. 
He is also the Executive Sponsor of Medtronic Women's Network in Asia Pacific.

Dominik holds a M.Sc. degree in Pharmacy from the Medical University of Warsaw.

In 2012, Dr. Vogel joined Duke-NUS Medical School as Associate Professor to lead the Voice Annotated Presentation Project and to facilitate clinical research projects. Later that year, she took on the role as Assistant Dean and subsequently Associate Dean of the Office of Graduate Studies. Today, in her capacity as Senior Associate Dean, she manages the administrative, academic and educational affairs of the three PhD programs, advancing new programmes and initiatives, including the development of new accredited programs at Duke-NUS supporting life-long learning for professionals. In 2016, she was inducted as a new Fellow of the NUS Teaching Academy. The Academy consists of Fellows who are committed to improving teaching and learning and who can build a culture of high-quality teaching at NUS.

In 2014, with the creation of the Centre of Regulatory Excellence, she became the Deputy Director for Centre. Her role is to implement education and research initiatives and oversee the strategic management of CoRE.
Prior to her role at Duke NUS, Dr. Vogel worked at Columbia University. Upon completing her postdoctoral training at Columbia University, she was promoted to Assistant Professor (tenure track) and directed a research laboratory with a focus on understanding factors involved in the development of obesity and insulin resistance in the Department of Medicine at Columbia University. While on the faculty at Columbia University, she also taught Master of Science students and health care professionals in the Institute of Human Nutrition, and initiated the use of online learning resources in the classroom.

Educational Background
High School from Saint Gabriel's College
Bachelor Degree, Faculty of Pharmacy, Mahidol University
Master Degree , Marketing, Faculty of Business Administration, Sripathum University
Certificate of Financial Management Program, Chulalongkorn University
Advanced Certificate Course in Public Economics Management for Executives, King Prajadhipok’s Institute
Certificate of Business Management Development Program, Singapore Management  University (SMU )  , Singapore
Experience
President of Thai Medical Device Technology Industry Association ( THAIMED ) Year 2010-2018
Chairman of ASEAN Federation of Medical Device Industry ( ASEANMed) Year 2012- Year 2018
Executive Board of Thailand Center of Excellence for Life Sciences, Ministry of Science and Technology Year 2012-2016
ASEAN Country Manager of Edwards Lifesciences Year 2000- Year 2013
Expert of Medical Device Committee, Food and Drug Administration Thailand, Ministry of Public Health Year 2014-2017
Member of Medical Device Cluster Development Project Committee, Ministry of Industry
Expert member of International Trade Negotiations Committee Board of Trade of Thailand
Subcommittee of Board of Commissioner of Science and Health, The Senate , Royal Thai Government
Committee Member of Health Intervention and Technology Assessment Program, Ministry of Public Health
Advisor to Thai Medical Instrument Association and Board Director of Marketing Pharmacy Association of Thailand( MPAT )
Advisor to Committee on Economics ,Commerce and Industry ,Senate Standing Committee ,Royal Thai Government
Company Director /Board Director /Chief Operating Officer of Techno Medical PCL
Awards
Yr 2003 World cup Award – Edwards Lifesciences Best Country of the year Award
Yr 2004 Living our value Award –Edwards Lifesciences
Yr 2012 Marketing Pharmacist of the Year Award /Outstanding Performance
Marketing Pharmacists Association of Thailand
Yr 2015 Marketing Pharmacist of the Year Award /Outstanding Performance
The Pharmaceutical Association of Thailand under Royal Patronage

AT NISHITH DESAI ASSOCIATES
Dr. Milind Antani, a renowned surgeon turned lawyer, leads the Pharma & Healthcare practice at multi-skilled, research-based international law firm, Nishith Desai Associates where he represents high net-worth clients in matters allied to JVs, M&As, VC and Private Equity investments, Collaborations, Regulatory advice, IP, Licensing and Commercialization. He also leads the Social Sector Practice and represents various global and national foundations in India.

AREAS OF PROVEN EXPERTISE
He has authored and co-authored numerous articles and prestigious publications related to the Pharma and Healthcare industry. Various national as well as international publications such as Digital Health Legal, a Cecil Media Publication in UK continue to reach out to Dr. Antani for insights and have carried his word. A regular speaker at various prominent forums on Pharma, Medical Devices, Med-Tech & eHealth, Biotech, IP, Clinical trials, Healthcare, CSR and Social Impact investments, he is also a visiting faculty at premier institutions in Mumbai and Gujarat including the Institute of Rural Management, Anand (IRMA).

PUBLISHED AUTHOR
Dr. Antani has co-authored the magnum opus “Contract Research and Manufacturing Services (CRAMS) in India: The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors, a Woodhead Publishing Series in Biomedicine and Indian Pharma and Life Science Industry- Legal and Tax Framework published by CCH, A Walter Kluwer business.

OUT OF OFFICE
Dr. Antani is a firm believer in the adage, “Soft Skills are the Hard Skills,” by Amy Edmondson, professor of leadership and management at Harvard Business School (‘Doc’ has also successfully completed a certificate course in professional services marketing from Harvard) and to this extent is a certified Soft Skills trainer. A voracious reader, given his love for assimilating knowledge across fields and varied thought pools, he pegs ‘Jonathan Livingstone Seagull’ by Richard Bach, ‘See you at the Top’ by Zig Ziglar and ‘Na-Hanyate’ by Maitreyi Devi as his favorites. He also enjoys watching the good ole telly and is a fan of Gujrati plays.

Philip Desjardins is a Vice President, Global Regulatory Affairs Policy & Intelligence, Johnson & Johnson. In this role, Mr. Desjardins oversees Johnson & Johnson’s global medical device regulatory policy activities. Phil’s organization is responsible for creating a unified and consistent global policy voice across the Medical Device segment. He leads a global team of dedicated policy experts to direct, guide, and implement policy initiatives. His organization develops and fosters relationships with strategic leaders internal and external to J&J to enable effective product/pipeline development strategies, product introduction strategies, and overall business growth across Medical Devices.

Mr. Desjardins previously served as FDA’s Associate Director for Policy within the Center for Devices and Radiological Health, and practiced law that the Firm of Arnold & Porter in Washington DC. Throughout his career, Mr. Desjardins has counseled Industry and FDA leadership on regulatory issues and helped shape, draft and implement global regulatory policies for medical devices.

George has been in the medical device industry in a variety of roles for over 30 years including Sales, Marketing, Business Development, General Management, R&D, Clinical, Regulatory and Government Affairs. He has worked for Stryker in Australia, USA and across Asia.
George is a member of the MTAA Public Affairs Committee, Chair of the MTAA Regulatory Affairs Committee, member of the APACMed Regulatory Affairs Committee, Chair of the Advamed China Regulatory Committee, and member of the Orthopaedic Global Benchmarking Working Group.
He has published work on biomaterials and joint implants, lectures in Biomedical Engineering, and has recently completed a Masters of Clinical Research from Liverpool University in the UK.
George is currently Vice President of Regulatory and Government Affairs for Stryker South Pacific.

Jason Guo, APAC Director, International Regulatory Affairs, Abbott, was graduated from SJTU (Shanghai Jiao Tong University, China) and earned double-bachelor degrees from there; he also acquired master degree of International Business Administration from UBC (University of British Columbia, Canada). He is now working for Abbott and taking the position as RA Director for the APAC region to oversee the strategic planning and execution of international regulatory affairs function. Prior to joining Abbott, he had worked for several US and European medical device MNCs, where he accumulated rich experience in regulatory and quality area as manager, plant director and regional director. He is currently sitting in the vice chairperson position of RA Committee for APACMed, where he actively advocates regulatory convergence and collaboration between industry and regulators.

Mike is actively involved in numerous industry groups, including the Association for the Advancement of Medical Instrumentation (AAMI) where he served on the Board of Directors for sixteen years and was Chair from 2014-1016. Mike also serves on the AAMI Foundation Board of Directors.

He is co-Chair of the AAMI Sterilization Standards Committee which serves as the US Mirror Group for ISO/TC198 and is a past member of the Committee on Standards Strategy. Mike is the Convener of ISO TC198/WG7 on Medical Packaging, responsible for the globally harmonized standard EN ISO 11607-1 &-2 and guidance EN ISO TS 16775; a member of the editorial board for Pharmaceutical and Medical Packaging News; and a 30-year member of the American Society for Microbiology.

Mike has a diverse research background and is credited with six U.S. patents and more than 60 published papers and articles. Prior to joining DuPont in 1988, he was a tenured member of the faculty at the University of Memphis.

Mike earned a bachelor’s and master’s degree in microbiology from the University of Central Florida and was awarded the Ph.D. from North Carolina State University. In 1994 he received the Professional Alumni Achievement Award from UCF College of Health and Public Affairs. He was honored again in 2006 when he received the Alumni Professional Achievement Award from the Burnett College of Biomedical Sciences at the UCF. He received AAMI Standards Developer Awards in 2010 and 2015.

Mike and Muffy live in Elkton, Maryland and keep busy with golf, travel, and nine grandchildren from their four children.

Robin Newman joined Johnson & Johnson last fall as our new WW Vice President for Clinical R&D. Robin comes to us from the Food & Drug Administration where she served as the Director of the Office of Compliance at CDRH, and primary champion and leader for Dr. Jeff Shuren’s signature program, The Case for Quality.
Dr. Newman began her career in clinical research as an operating room nurse coordinating clinical trials. From there, she joined the University of Texas Southwestern Medical School as a Pediatric Nurse Practitioner and head of the clinical research program for Pediatric Cardiology. In the mid 90s, joining forces with a handful of other research nurses, Robin founded a clinical research and regulatory consulting firm in Dallas, Texas called MedTrials, where she served as EVP and head of medical device research services for 15 years. While obtaining her doctorate, she moved her career to industry, working as Vice President of Quality Management for Siemens. In this role, Dr. Newman managed a global multidisciplinary team of quality, regulatory, and clinical affairs professionals and functioned as the primary company representative to several industry and regulatory working groups. Robin holds a B.S. and M.S. in Nursing from the University of Texas, and an Ed.D. from The George Washington University’s Executive Leadership Program. Dr. Newman also holds certifications as a Pediatric Nurse Practitioner (CPNP - PNCB), in regulatory affairs (RAC -RAPS), as a quality auditor (CQA-ASQ) and as a clinical research associate (CCRA - ACRP).

Fredrik brings 30 years experience in the medical technology industry, 24 of which were spent in Asia-Pacific. He has worked across the region and lived in Singapore, Malaysia and Japan.

He has a background in both senior strategic consulting roles and in operational sales, marketing and general management positions.

Fredrik has also worked extensively with start-up medical technology companies both as advisor and as venture capitalist. He was most recently Senior Director and medical technology Practice Lead at Quintiles Consulting, based in Singapore.

He began his career in Asia with Ohmeda, now separate units of GE Healthcare, Becton Dickinson and Baxter.

Fredrik holds a BSc from Gothenburg University, Sweden, and an MBA from Henley Management College, UK.

Jesús heads the international affairs team. He continues to lead the regulatory debates that affect IVDs at EU level. Directly involved in the discussions on the revision and recast of the IVD Directive, he is also involved in the work at the international level acting as representative to WHO, ISO and as liaison to other associations on all regulatory matters.

Miang is a Pharmacist, MBA. She has more than 20 years of regulatory affairs experience with numbers of Medical devices and Pharmaceutical companies.

Her current position at Alcon is the Regional head of Regulatory Affairs, Asia Pacific & Russia. Miang has a board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific including Japan. Prior to Alcon, Miang worked for numbers of healthcare companies (Takeda, Boston Scientific, JNJ, Actelion, Cochlear, Bausch & Lomb and Zimmer) 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 co-chair of APACMED Regulatory Affairs group and an industry
secretariat of AHWP TC.

Katherine Wang is a partner in Ropes & Gray’s life sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, regulatory/GxP compliance, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the National Medical Products Administration (NMPA), the National Health Commission (NHC) and the State Administration of Market Regulation (SAMR), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China.

Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.

Over 20 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products. Received awards on improving process (reduced 20% in product launch time) and developing People (Watson Wyatt Survey to all direct reporting staff indicated that 100% of them able to contribute to their fullest ability).

Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 2800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with over 3600 members. Wrote the First Asia Regulatory Book in Asia, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.
Six Sigma Black Belt certified by IASSC

Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by BSI (British Standards Institution).