Finny Liu is the APAC Regional Regulatory Policy Lead, Product Development Regulatory, at Roche based in Singapore, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in APAC. Previously, she was the Head of APAC International Operations at Roche located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for Roche products to ensure right first-time submissions to Health Authorities during Aug. 2013 to June 2016.

James is in charge of identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region, and establishing education roadmaps, priorities and deliverables. In this role, he actively conducts discussions with regulatory affairs professionals across Asia Pacific, and develops training workshops to enhance regulatory competencies, He is involved in regional and global initiatives for regulatory systems strengthening. James draws his experiences as a regulator in Singapore’s Health Sciences Authority, hospital pharmacist, and his PhD on benefit-risk decisions and innovation in regulatory affairs.

Audrey is the Head of Business Development at Clinical Research Malaysia (CRM). She has over 10 years of experience in the clinical research field, with cross-functional roles in marketing, project management, stakeholder management, corporate communication, and medical writing. At CRM, she is responsible for growing industry-sponsored research in the country. Her role includes strategizing and executing the organization’s business plan, working closely with stakeholders and industry players to create a thriving clinical research ecosystem, and contributing to national policies, frameworks and guidelines to catalyze clinical trials in the country.

Dorothee Grimald has been leading the Regulatory Policy activities for Asia Pacific at MSD (Merck Sharp & Dohme) for the past 7.5 years. She held this position in Singapore, while she has now relocated to Europe. Mrs Grimald has over 20 years of experience in the Life Science Industry, mainly in the Regulatory Affairs and Policy fields. She is an active representative in several regional and international industry collaboration platforms, including the DIA Singapore Annual Meeting since its launch 5 years ago. Before moving back to Europe, Dorothee worked in Singapore, China, France and in the UK. Dorothee Grimald is French and Pharmacist by training with a degree in Business Management.

•Founder of Asia Regulatory Professionals Association (ARPA) with more than 7000 members •Author of Medical Regulatory Affairs Handbook (3rd Edition now) •Adjunct Professor/Lecturer in Chinese University of Hong Kong, National University of Singapore and Tohoku University Japan •CEO of RNAscence (a Biotech startup spin off from Nanyang Technological University and National Skin Center Singapore) •More than 26 years experience in Pharma and MedTech sector

Dr. Senthil Sockalingam is Head of IQVIA Biotech in Japan-Asia Pacific as well as Chief Medical Officer (CMO) for IQVIA Asia Pacific based in Singapore. Senthil is a physician by training, acquiring a MBBS degree from the University of Malaya and practicing in Malaysia prior to joining the industry. In his current role, he leads IQVIA’s specialized clinical development services for the Biotech sector across Japan-Asia Pacific. In addition, he is overall responsible for the safety and ethics of IQVIA clinical development projects in the Asia Pacific region. Prior to joining IQVIA, Senthil led clinical development and medical affairs for several pharmaceutical companies in the region.

Thean Soo Lo is a Regulatory Affairs Management Consultant specializing in the design and development of a robust, efficient, forward looking regulatory department within the organization to provide optimal support to the business, through optimal and expeditious product registration and product license maintenance within the organization. Thean Soo Lo is a pharmacist by training, with a B. Pharmacy (Hons) degree, and a MSc degree on comparative analytical methodology and pharmacokinetics of drugs in biological fluids. Prior to his current role, Thean Soo Lo had prior experience as the AP Lead for regulatory policy & intelligence, and AP Regulatory Affairs Head in Janssen Pharmaceuticals, J&J.

Vicky offers more than 17 years of leadership and management experience including the operational oversight of multi-therapeutic, global Phase I-III trials as well as early clinical development operational strategy. She is currently overseeing and managing multi-compound portfolios across multiple therapeutic areas at global level. She is responsible and accountable for the operational delivery for APAC Biotech Business Unit for the studies conducted regionally and globally. She also drives the Cross-Business Service Units collaborations at programs / accounts level cross the regions.

Yasha Huang is currently the Head of Regulatory Policy Asia Pacific at Roche Diagnostics. She was most recently the Regulatory Affairs Director at APACMed, the region’s first and only MedTech industry association. Yasha also worked as a regulator for 7+ years with the China FDA, where she was actively involved in global governance and stakeholder engagement, with international organizations, government agencies, NGOs, etc. She authored papers on regulatory competency framework, acceptance of overseas clinical performance evaluation, regulatory agility during pandemic, IVDR impact on Asia Pacific markets, etc. She is currently Chair of IVD Working Group within APACMed RA Committee.

Mr. Jin is currently Head, Regulatory Competency Center Asia Pacific, Middle East and Africa (APMA) at Sandoz Asia Pacific Pharmaceutical Pte. Ltd. He is responsible for all regulatory related activities in Asia Pacific, Middle East and Africa (APMA). Mr. Jin has been working in regulatory affairs field in pharmaceutical industry for more than 20 years. He has extensive expertise in regulatory affairs and in the drug development in the region. Prior to joining Sandoz, he worked in Abbott, AbbVie, Takeda, Parexel and GE Healthcare. Mr. Jin is trained as a pharmacist with business degree.

Dr Yeo Jing Ping has more than 25 years of experience in Clinical Research in the Pharmaceutical and CRO industries. She was previously the Vice President and Head of Asia Pacific in Cytel, responsible for leading the growth of Cytel. Prior to Cytel, she was the Research Director, leading the compliance and IRB matters, ensuring all research at the institutions/hospitals were conducted according to legislative requirements, ethical principles and standards. She was previously the Corporate Vice President for PAREXEL International CRO, leading the global biopharmaceutical unit in project delivery and for providing strategic consultancy to the biopharma companies.

Kum Cheun (KC) is Head of Asia Pacific Regulatory & Development Policy for Novartis, leads in the development of regulatory and development policy, and regulatory intelligence for Asia Pacific. He is Co-Chair of Singapore Association of Pharmaceutical Industries (SAPI) Regulatory Affairs Committee, Chair of EFPIA ASEAN Regulatory Network, ASEAN Pharmaceutical Research Industry Association (APRIA) and active member of EFPIA International Regulatory Expert Group (IREG), EFPIA regional regulatory networks (India, Korea-Taiwan), DIA Steering Committee of Singapore, DIA Asia Labelling Community member, ISPE Asia Pacific Focus Group, Steering Committee of APAC, member of APAC RA-EWG, member of APACRM and CoRE Duke-NUS Visiting Expert.

Fengyun (Vicky) Han, the Senior Director, Head of Asia Pacific Regulatory Policy, Global Regulatory Affairs, Johnson & Johnson Vicky has more than 25 years regulatory experience in pharmaceutical industry mainly in GSK ang J&J with various roles in China, Belgium, UK, and Singapore, encompassing a wide range of products, including chemical and biological products, vaccines, biosimilars, and generics. In recent year, she has been involving in many policy areas discussion such as MRCT & ICH E17, RWE, Digital/AL/ML, Cell & Gene Therapy, Orphan Drug, Regulatory Reliance etc.Vicky is the Chair of EFPIA Japan Network, and Vice-Chair of EFPIA China Network.

Professor John CW Lim is founding Executive Director of the Duke-NUS Centre of Regulatory Excellence (CoRE), inaugural Chairman of the Consortium for Clinical Research & Innovation Singapore, Senior Advisor at Singapore’s Ministry of Health (MOH), and Policy Core Lead at the SingHealth Duke-NUS Global Health Institute. Formerly Chief Executive Officer of Singapore’s Health Sciences Authority and Deputy Director of Medical Services in MOH, Professor Lim has also held other senior positions in Singapore’s Health and Education ministries.

Aparajeeta Priyadarasini has over 14 years of experience in the healthcare and life sciences industry. She has held various roles in global pharmaceutical companies and contract research organizations, covering clinical research, biotechnology, medical devices.She was responsible for clinical operation of different study phases for Sanofi Aventis, Asia-Pacific Regional HQ prior to Medidata. In her current role, Aparajeeta provides consulting to the pharmaceutical, biotech and CRO companies on clinical operations process and technologies.

Adj A/Prof (Dr) Raymond Chua is a Registered Medical Practitioner and Public Health Specialist. He is currently the Deputy Director of Medical Services, Health Regulation Group to oversee the regulations of healthcare services and premises in Singapore, so as to safeguard public health and enable healthcare innovations. He is concurrently designated by Cyber Security Agency of Singapore (CSA) as the Assistant Commissioner for Cybersecurity in Healthcare, to assist CSA in tracking and enhancing the cybersecurity posture of the Critical Information Infrastructure (CIIs) in the healthcare sector.

Pramod Pratap has over a decade of rich and varied experience in marketing and digital communications - spanning across both corporate houses & digital agencies. He currently heads Marketing for Healthcare, Insurance and Life Sciences verticals at Infosys. With a portfolio of $1B revenue, Pramod drives demand generation and account-based marketing via multiple outreach channels of events, media, analyst relations, digital marketing among others. His marketing campaigns & solution launches for the unit business have won several awards from leading industry organizations.

A seasoned management executive and astute medical professional, offering 20+ 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.Championed providing guidance and advice on regulatory functions within Medical Device sector. Trusted leader, strategic thinker, and technical innovator specifically in the areas of radiology, biomedical engineering, and clinical engineering.

Jerome is currently leading the Asia Clinical Development & Operations Strategy group. In this role, he has under his leadership the Decentralized trials COE and the Patient Recruitment Solutions, enabling the deployment of Patient Centric approaches. His group also includes the Therapeutic Strategy Leads & Feasibility groups, the Cell and Gene Therapy COE and the Clinical Trial Educators oversight. Prior to his current role at IQVIA, Jerome held various positions in legacy Quintiles both in the France and Singapore offices, In Ventiv Health, in Parexel, and as a freelancer. Jerome holds a Master Degree in Molecular Biology and Applied Genetic from University of Toulouse III, France.

JESUSA JOYCE N. CIRUNAY is a Registered Pharmacist (cum laude). She is currently the Director IV of the Center for Drug Regulation and Research at the Food and Drug Administration Philippines. Her government service began at the Product Services Division (PSD) covering Marketing Authorizations as Pharmaceutical Researcher then as Senior Drug Evaluator including New Drug Applications and Vaccines. Before her current post, she was assigned to head several key offices of the Agency at various timelines, i.e., Field Cluster Director in various parts of the Philippines, as Head of the GMP Inspectorate; as Head of the Distribution Inspectorate and as Head of the Marketing Authorization.

Dr. Wen-Yi Hung joined TFDA in 2012 after she acquired her PhD degree in Pharmacology from National Yang Ming University. She is now Senior Reviewer in the Section of New Drugs and works on the development of regulations for new drugs, including regenerative medicinal products. Her working experience also includes regulatory affairs regarding clinical trials, bioequivalence studies and GCP inspections.

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.

Stephen has two decades of experience as a strategic advisor and leads L.E.K.’s Digital Health practice in Asia. He has advised on organic and digital growth investments as well as partnering and M&A situations, working with some of the largest investors and most complex multinational healthcare enterprises in the world, as well as smaller innovative startups. He also works with governments and industry associations. He has been invited to share his perspectives on Asia’s healthcare industry development at various industry gatherings including Healthcare Business International and Healthcare Capital and Connections Summit, as well as published in various journals including In Vivo, Bioworld, Orthoknow, Medtech Dive and MedTech Strategist.

Audrey is known for revitalizing the computer languages Perl and Haskell, as well as building the online spreadsheet system EtherCalc in collaboration with Dan Bricklin. In the public sector, Audrey served on Taiwan national development council’s open data committee and the 12-year basic education curriculum committee; and led the country’s first e-Rulemaking project. In the private sector, Audrey worked as a consultant with Apple on computational linguistics, with Oxford University Press on crowd lexicography, and with Socialtext on social interaction design. In the social sector, Audrey actively contributes to g0v (“gov zero”), a vibrant community focusing on creating tools for the civil society, with the call to “fork the government.”

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international level to facilitate and accelerate the introduction of priority medical products in countries. Before joining the WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

Charles Warne is a biostatistician with >15 years’ experience in the life sciences setting, of which the past 10 have been spent as a clinical trial biostatistician in the pharmaceutical and biotechnology sectors. He is experienced across early and late phases of drug development in multiple therapeutic areas including oncology (solid and hematologic malignancies), inflammation, infectious diseases, central nervous system and metabolic disorders. Prior to joining Cytel, Charles was Director of Biostatistics at Tessa Therapeutics (Singapore), and prior to that worked in biostatistical roles at Roche Products and PAREXEL International in the UK, and in medical research organisations in Australia.

Karen Alparce-Villanueva has over 30 years experience in communications & policy work in various industries: consumer, insurance, travel and pharmaceuticals, the latter of which she spent the last 20 years. Karen left her corporate job 7 years ago to devote her long experience in health advocacy to advancing patient rights through her support of the Philippine Alliance of Patient Organizations (PAPO) where she currently serves as President. She also sits as Board Member of the Philippine Tuberculosis Society Inc. (PTSI) and is also a Governing Board Member of the International Alliance of Patient Organizations’ Patients for Patient Safety (IAPO P4PS).

Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development. Prior to joining Roche, Ralf held roles of increasing responsibility in technical R&D at Merck KGaA and Novartis. He has a PhD in pharmaceutical technology from the Philipp University Marburg, Germany.

Nathan A. Carrington (Nate) is the Head of Digital Health and Innovation for the Global Regulatory Policy and Intelligence team at Roche Diagnostics, located in Indianapolis, USA. In this role, Nate collaborates with internal and external stakeholders to develop and execute strategies related to a number of regulatory policy initiatives. His current areas of focus include Digital Health-related topics such as software qualification, SaMD classification, software clinical evidence requirements, requirements for AI-Based SaMD products, and Real World Evidence. Nate received his Ph.D. in Analytical Chemistry from the University of Tennessee and began work at Roche Diagnostics in 2007 as a Principal Scientist.

Serena Chan has over 19 years’ experience in the pharmaceutical and CRO industry starting as a clinical/community pharmacist, then moving into Clinical Research. During her 7 years at Syneos Health, Serena has been empowered to be an agent of change, collaborate with diverse networks and drive unification across APAC.

Jey is a recognized Digital Health Strategist on addressing the challenges facing the global Healthcare & Life Sciences industry and prospects for improving patient outcomes through better use of data and information. Jey brings his 20 plus years of broad consulting experience with Healthcare Providers, Public Health & Pharmaceutical R&D that spans biotech, pharma and CRO. He is the President of the Healthcare Information and Management Systems Society (HIMSS) India chapter. He was the member of the drafting committee for Digital Health Standards, National Accreditation Board for Hospitals & Healthcare Providers (NABH) in India.

Seasoned Global Healthcare Leader, Anh Bourcet (Nguyen) has a 15-year track record of driving excellence and transformation in Market Access for pharmaceuticals, medical devices and diagnostics. Known for establishing strategic multi-stakeholder partnerships, Anh has shaped access policies, built the Market Access function from the ground up, transformed clinical practices, for earlier/optimised patient access to innovations. Anh held leadership positions in Abbott and Johnson & Johnson in APAC, and at the French Health Safety Agency (ANSM). She is currently Strategic Advisor for APACMed (Asia-Pacific Medical Technology Association).

Raj has 20 years of experience in healthcare advocacy, policy and governance. As Executive Director of Rainbow Across Borders, he has created and led specific illness patient access programmes and campaigns. He has also initiated and built an extensive network comprising policy makers, industry players, healthcare professionals and patients with regional and loca platforms. As Principal Consultant at Manifeste LLP, Raj has been creating solutions for multiple stakeholders in economically and culturally diverse countries in the Asia Pacific region. He has been able to revitalise strategies to overcome a multitude of challenges in the healthcare sector.

As part of Medtronic's global regulatory policy team located in Washington DC, Fatemeh is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance Medtronic's goal of helping patients access safe and innovative therapies. Fatemeh was previously the head of U.S. regulatory policy in BD. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). Fatemeh received her B.S. in biomedical engineering and M.S. in electrical engineering from George Washington University.

Daniela holds a PhD in Chemistry from The University of Adelaide, South Australia, and has a strong research background having worked in cardiovascular and heart-disease related drug development research for over 8 years. Daniela has over 16 years’ experience in the clinical trial industry joining Pfizer Pharmaceuticals in 2006 before moving to Novotech Health Holdings in 2009. Since joining Novotech Health Holdings, Daniela has held several positions within the Clinical Operations function with the most recent appointment as Senior Director Clinical Services and Innovation.

Dr. Shinichi Okudaira is Division Director of Division of International Cooperation, Office of International Programs at Pharmaceuticals and Medical Devices Agency (PMDA). Dr. Okudaira joined PMDA in 2013 and has about 10 years' experience as a reviewer of new oncology drugs, biosimilars, cell and gene therapy products befor he moved to current division in 2023. Before joining to PMDA, Dr. Okudaira was an assistant professor in Graduate School of Pharmaceutical Sciences, Tohoku University. Dr. Okudaira holds a PhD in Pharmaceutical Sciences from Graduate School of Pharmaceutical Sciences, The University of Tokyo.

Dr Andrew Pengilley is a Public Health Physician currently working as the Senior Medical Advisor for the Therapeutic Goods Administration’s (TGA) International Regulation Branch. He has over 20 years experience as a regulator, and has been the head of the TGAs clinical assessment units for cardiovascular and cancer therapeutics. Outside of TGA, Dr Pengilley has worked as the deputy head of the local ACT public health unit, and as a senior medical advisor for the Australian Department of Health in pandemic and other emergency response planning.

Dr. Sornaraja Thasma serves as Director of Business and Quality Assurance, leading the integrated teams within ProRelixResearch committed to delivering exceptional clinical development services and flexible support to Pharmaceutical/Biotech and medical device clients.Dr.Thasma has over 2 decade of clinical research experience both within the pharmaceutical and CRO sectors. During this time he has worked at all levels and across operational and commercial functions within the industry. Dr.Thasma has held roles including Global Head of the Clinical Research Division at ProRelixResearch. Within each role he has made significant contributions to the successful growth and development of the company through his strategic business plans.

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 and maintenance of regulatory documents; managing international affairs and inter-agency agenda; development of policies, guidance documents and guidelines; industry facilitation; managing events; provide trainings and consultancy and perform other specific projects. She also performed quality management system audits; medical device registration and licensing evaluations and verifications prior to her current role.

Martin Lim, based in Singapore, is a managing consultant at NNIT, a Copenhagen-based Life Sciences IT consulting firm and has over 20 years of experience in healthcare software product management, clinical research site management and co-founding a digital clinical research start-up. Martin is passionate about digitalizing and building capacity/capability for clinical research in ASEAN. Martin holds an BS in Biology from UC Irvine, MS in Physiology from Georgetown University and an MBA from UCLA.

Neil Smith is the Director of Clinical Operations for ObvioHealth based in Melbourne, Australia and is responsible for the oversight of the company’s regional APAC studies. He brings 25 years’ experience in clinical research to this new role, having led and/or supported all phases of regional and global clinical trials from start up to close out. Neil built his CV at Novartis, IQVIA, PPD and Parexel Pharmaceutical across a broad range of roles and responsibilities. His first monitoring role in the industry was to bring “Telfast” to the world. Later in his career , he worked on more complex clinical trials in HIV, Oncology and Hematology in both South Africa and Australia.

Dr. Sherry WANG is the Head of Regulatory Commercial Services in IQVIA, overseeing all regulatory efforts covering JAPAC; leading pre-market regulatory strategies, advisory, dossiers preparation, market authorization approval; post-market license renewals in products LCM, and setting up regulatory departments for partners.

With more than 25 years of experience within the life science industry, Franciska has worked for numerous Life Science organizations and technology vendors, supporting customers on their strategic digitalization journeys across clinical operations and data management. Franciska now leads the Global Clinical Advisory & Consulting program for NNIT – providing domain and IT services to Life Science organizations around the world..

Yu currently holds the position of Associate Director, Regulatory CMC APAC at MSD. He is part of the Technical Advocacy and Policy group for APAC, advocating for topics including reliance and agility, PACMP and ICH Q12. He is a member of the IFPMA ICH M4Q(R2) EWG representing Singapore through SAPI. Yu holds a master’s degree in Pharmaceutical Sciences from Université de Montréal and a bachelor’s degree in Pharmacology from Université de Sherbrooke in Canada.

Gurdeep is AVP and Portfolio Head in the Life Science sector. He also leads Infosys Digital Health Platform solution and services business. For ~25 years, he has been part of Infosys providing IT solutions and consulting services across Digital, Automation, Analytics, IoT, Security, Cloud Transformation, Connected Health, and more. He has personally led deals and managed execution for a variety of initiatives including nationwide data aggregation and reporting capabilities, sales and marketing portfolio management, digital marketing factory, software + services solutions, digital manufacturing initiatives, advanced analytics solutions, information security services, ecommerce solutions, and a variety of digital health solutions.