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Virtual

Jul 07, 2021 8:45 AM - Jul 08, 2021 5:40 PM

(Singapore Standard Time)

DIA-CoRE Singapore Annual Meeting 2021

Speakers

Dorothee  Grimald, PharmD

Dorothee Grimald, PharmD

Director, Global Regulatory Policy , Merck Sharp & Dohme (MSD), Germany

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.

James  Leong, PhD, MPharm

James Leong, PhD, MPharm

Head,Health Products & Regulatory Science Centre of Regulatory Excellence (CoRE), Duke NUS Medical School, Singapore

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  Ooi, MSc

Audrey Ooi, MSc

Head- Business Development, Clinical Research Malaysia, Malaysia

Audrey Ooi is 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 engagement, corporate communication and medical writing. At CRM, she is responsible for growing sponsored-research in the country, working with various stakeholders to enable a robust and thriving clinical research ecosystem. One of her key contribution is in developing the country’s capabilities in early phase clinical research.

Finny  Liu, MSc, RPh

Finny Liu, MSc, RPh

APAC Regional Regulatory Policy Lead, Roche, Singapore

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 Jun. 2016. She holds a Master Degree in Pharmaceutical Technology and a Bachelor Degree in Pharmacy, both from the National Taiwan University, Medical College.

Jack  Wong

Jack Wong

Founder, ARPA (Asia Regulatory Professionals Association) , Singapore

Over 25 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Nutritional, Pharmaceuticals, Medical Devices, Consumer Healthcare and Biological products.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 3800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professionals Associations) since 2010 with over 4800 members. Wrote the first Asia Regulatory Book, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.

Mei  Ding

Mei Ding

JAPAC Regional Lead, Policy & Intelligence, Abbvie Pte. Ltd., Singapore

Mei Ding is broadly involving in advocacy and policy activities in Japan, China, Korea, Taiwan and ASEAN region. Mei is a pharmaceutical professional with extensive experience in regulatory affairs across several therapeutical areas and geographical regions. Before joined AbbVie, Mei worked with several MNC pharmaceutical companies, including global regulatory strategy role for entire emerging markets and regional regulatory strategy role for Asia and Middle-east regions at Boehringer Ingelheim based in Germany and Singapore as well as China RA role at Eisai, Grunenthal, Wyeth and Novartis based in China. Before Mei joined Industry, she worked with China Regulatory Agency.Mei holds a Bachelor’s degree in China Pharmaceutical University.

Thean Soo  Lo

Thean Soo Lo

, Regulatory Affairs Management Consultant, Singapore

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  Hsu

Vicky Hsu

Senior Vice President, Head of Project Leadership and Biotech Operations Asia, Parexel International, Singapore

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

Yasha Huang

Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence, Roche Diagnostics, Singapore

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.

Senthil  Sockalingam

Senthil Sockalingam

M.D, Head of IQVIA Biotech, JAPAC, Chief Medical Officer, IQVIA, APAC, IQVIA, Singapore

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.

Shun  Jin, MBA

Shun Jin, MBA

Head, Regulatory Affairs, APMA, Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore

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.

Kum Cheun  Wong, PharmD

Kum Cheun Wong, PharmD

Head Asia Pacific Regulatory & Development Policy, Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore

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.

Jing Ping  Yeo, PhD

Jing Ping Yeo, PhD

Head - Transformation, George Clinical, Singapore

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.

Fengyun(Vicky)  Han

Fengyun(Vicky) Han

Senior Director, Head of Regulatory Policy for Asia Pacific, Johnson & Johnson Pte. Ltd., Singapore

Vicky Han is Senior Director at Janssen Pharmaceuticals and head up the Asia Pacific Regulatory Policy since 2016. Her experiences span Asia & Europe and cross pharmaceutical, biological, vaccines, and generics. She dedicated 18 years of her career to GSK where she held several positions in various countries. She led the RA team in pharmaceuticals and vaccines in GSK China before moving to GSK vaccines headquarters in Belgium in 2008. In GSK Vaccine, she led the cross-product regulatory affairs team to deal directly with the European Medicines Agency (EMA) regarding vaccine registration. In 2011, she relocated to GSK Pharmaceuticals headquarters in London as the Senior Director to oversee the regulatory strategies in China/Asia.

Nicholas J Diamond

Nicholas J Diamond

Director, C & M International, United States

Nicholas Diamond is a Director and leads the Global Health Practice at C&M International, the global policy and regulatory affairs affiliate of Crowell & Moring LLP, in the Washington, D.C., office. He also serves as a part-time law professor at the Georgetown University Law Center, also in Washington, D.C.

Swapna  Kondapuram

Swapna Kondapuram

Principal Global R&D/ RWE , IQVIA Consumer Health, Singapore

Based in Singapore leading Consumer health Clinical & Real World Evidence, Claims Substantiation and Regulatory Strategy across multiple categories particularly OTC, VMS & Nutrition. Engaging R&D, Innovation and Medical affairs leaders for clinical & claims substantiation programs linked to new product development, registration & new claim development.Consumer health category expertise in OTC, VMS Topicals, brand extension & innovation in Europe & Asia with leading CH MNCs such as Sanofi, Novartis & GSK Consumer Health.

Cheng Leng  Chan, PharmD

Cheng Leng Chan, PharmD

Group Director, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore

Associate Professor Chan Cheng Leng is the Group Director, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore. She has extensive and deep work experience in the area of health products regulation and safety monitoring. She plays a leading role in developing and implementing national policies and directing the operations with the objective of safeguarding and advancing public health. Under her leadership, HSA became the first National Regulatory Authority in the world in January 2022 to achieve Maturity Level 4 for medicines regulation, the highest level of attainment of regulatory excellence conferred by the World Health Organisation for operating at an advanced level of performance and continuous improvement.

Serene  Ong

Serene Ong

Vice President, Commercial Operations APAC, Marken LLP, Singapore

Serene Ong has 20 years of business development, healthcare and clinical trial experience with start-up companies, pharma, venture capital, hospital and major global clinical trial organizations in US, Europe and Singapore. She holds the dual role of VP of Global Sales Operations and VP of Commercial Operations, Asia Pacific for Marken.Having worked extensively in the clinical research side of the business she brings a unique perspective of the supply chain to her position. She is a Singaporean trained pharmacist, based in Singapore. She completed her EMBA at INSEAD in 2018. She also graduated with a Masters of Science (Pharmacy) from the National University of Singapore and a Minor in Technopreneurship from Stanford University.

Kevin  Wightman

Kevin Wightman

Senior Director, Business and Corporate Development Asia Pacific , Illingworth Research , Australia

With more than 25 years working in the clinical trials industry in a number of leading Pharma, CRO, Phase 1 and industries, in Australia, NZ and the UK, Kevin is passionate about improving the way clinical trials are delivered to better meet patients’ needs. He is an experienced Board Director and a member of the Australian Institute of Company Directors. His role leading Illingworth’s Business expansion in the Asia Pacific region, enables him to follow his passion as a real “patient pioneer”, working to make clinical trials more accessible and less burdensome for patients and their families and carers, while focusing on providing sponsors, CROs and Sites with innovative and robust patient centric solutions to support their studies.

Jesusa Joyce  N Cirunay

Jesusa Joyce N Cirunay

Director IV , Center for Drug Regulation and Research (CDRR), Food and Drug Administration Philippines, Philippines

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.

Yanfang  LIU

Yanfang LIU

Senior Director Global Real World Evidence, Johnson & Johnson, Singapore

Dr. Liu Yanfang is Senior Director of Epidemiology Asia Pacific at Janssen Research & Development. She has over 20 years’ experience in clinical medicine and pharmacoepidemiology. Her research focuses on post-authorization safety studies and comparative safety and effectiveness of medications/vaccines in real-world settings. She severs as a core member of the Asia Pacific Protocol Review Committee.

Yuta  Maeda

Yuta Maeda

Coordinator, Division of Asia II, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

I joined PMDA in 2009. I’ve belonged to office of medical devices and office of new drugs at PMDA as a reviewer. Since 2020, I belong to Office of International Programs at PMDA. I’m now in charge of the contact between Asian countries and PMDA.

George  Mavromaras

George Mavromaras

Lead Product Manager, Digital Health Technologies (DHT), , Product Development, Personalized Healthcare (PDP), Genentech Inc, United States

Today, George Mavro is a serial entrepreneur, featured in the Dallas Morning News, HealthcareITNews, and MobiHealthNews. He has also contributed to online articles found on Mashable, INC.com, and Under 30 CEO through his involvement in the Young Entrepreneur Council (YES).He serves as a Lead Product Manager at Genentech Inc. working on Remote Vision Monitor. He joined Genentech Inc. in 2018 through the acquisition of the myVisionTrack® startup whereby he acted as the Chief Marketing Officer. Additionally, he led the branding, UI/UX and customer requirements for the product, specifically focusing his efforts around commercialization. He graduated with honors from the University of Texas at Dallas (UTD) majoring in Biology.

Roberta  Sarno

Roberta Sarno

Head Digital Health Committee, APAC Med, Singapore

Roberta joined APACMed in December 2019 to lead the new Digital Health Committee. She supports the association’s members to establish a digital health ecosystem, build knowledge and advocate for optimal policies that help digital health innovation in APAC. Prior to joining APACMed, Roberta worked as senior consultant and business development manager at Alcimed in Paris and Marseille, France, where she supported clients in the healthcare sector on innovation and strategy projects. Before that, she worked as genetic engineering researcher at Curie Institute, in collaboration with the French startup Meiogenix.She holds a PhD in genetics (Curie Institute, Paris), a master of business foundations (INSEAD) and lives in Singapore.

Sunitha  Shanmugam

Sunitha Shanmugam

Senior Regulatory Affairs Director SEAT , GSK Consumer Health , Singapore

Based in Singapore leading Consumer health Regulatory for GSK in SEA and Taiwan.She is working with GSK for 22 years and managing the regulatory portfolio for 19 years.Products supported are Consumer Healthcare products which include OTC Medicines, Health Supplements, Medical Devices, Cosmetics and Food products. Expertise/knowledge in Consumer Healthcare/Food regulatory management and facilitate in various Regulatory/Technical Working Groups in the industry associations with top priority to focus on strategic regulatory work working with the various Regulatory agencies across ASEAN, Hong Kong & Taiwan. This includes This includes Environment Modification – i.e. Switch, Advertising efforts and in the Harmonization work.

Nidhi  Swarup

Nidhi Swarup

Founder & President, Crohn’s & Colitis Society of Singapore , Singapore

Nidhi Swarup is the Founder and President of the Crohn’s & Colitis Society of Singapore (CCSS). Since 2012 the organization has focussed on creating public awareness, patient education, providing relief through support programmes for patients and their family members, promoting research into causes, prevention, and treatment of Crohn’s Disease, Ulcerative Colitis, and related inflammatory bowel diseases (IBD). She has facilitated the formation of IBD Patient Support Groups in Thailand, Malaysia, Philippines, and currently in India. As a key opinion leader, she has represented CCSS as a panelist, speaker and moderator at various local, regional, and global conferences, and seminars.

Steven  Tucker

Steven Tucker

Founder, Tucker Medical Singapore, Singapore

Dr. Steven Tucker is a Health Futurist and Preventive Oncologist. He is the Founder and Medical Director of Tucker Medical, a Singapore-based multi-specialty practice that combines both primary care and sub-specialty medicine in Singapore and to patients across South East Asia.He was Chief Medical Officer at CXA and previously held consulting and strategic roles at MetLife Asia, the Lumen Lab Innovation Center, and was the founding Global Health Advisor at Singtel. He is a Senior Health Advisor at Beyond Limits AI and a faculty member at the MIT - Singapore Alliance for Research and Technology (SMART) teaching medical innovation, design thinking, and entrepreneurship.

Chiyun  Yang

Chiyun Yang

Account Manager, Business Development, PRAHealthSciences , Singapore

Chiyun Yang, PhD, Business Development Account Manager, has 4+ years of Contract Research Organization (CRO) experience in commercial roles.

Hishamuddin  Badaruddin

Hishamuddin Badaruddin

Adj Asst Prof Hishamuddin Badaruddin, Duke-NUS Graduate Medical School, Singapore

Dr Hishamuddin Badaruddin is a public health specialist who has over 20 years’ experience in senior-level policymaking and healthcare management. He studied medicine at the University of Nottingham, UK, and worked in emergency medicine in various hospitals in the UK and Brunei before pursuing Public Health and Epidemiology. He subsequently obtained his Master of Public Health from Emory University, USA, as a Fulbright Scholar. He is a Fellow of the Academy of Medicine Singapore and an Adjunct Assistant Professor at both Duke-NUS Graduate Medical School, Singapore, and Penn State Medical College, USA. He has worked with the Ministry of Health in Brunei and Singapore and consulted for WHO, UNICEF and ASEAN.

Janie  Heywood

Janie Heywood

APAC Head of Regulatory Affairs , Bayer Consumer Health, Australia

Janie is based in Sydney, Australia leading an APAC Regulatory Affairs team providing strategic input to regulatory strategies, advise on market authorization processes and approval; to post-market license renewals. Driving competitive claims across health foods, cosmetics, OTC and general products. She has more than 21 years of global regulatory, medical leadership in consumer health. Co-chair of Health Authority / Regulatory Authority Liaison Meeting held quarterly in Australia. Mentor / coach for Bayer R&D Future Innovators program and Regulatory & Medical Future leaders.

Mei-Chen  Huang

Mei-Chen Huang

Section Chief, Division of Medicinal Products, TFDA, Taiwan

Ms. Mei-Chen Huang received her Bachelor Science degree from Department of Pharmacy, College of Medicine, National Taiwan University in 2004, and Master Science degree from Biochemistry and Molecular Biology, College of Medicine, National Taiwan University in 2006. She joined Taiwan Food and Drug Administration (TFDA) in 2010. In TFDA, she had experiences in new drugs, biological products applications, clinical trials applications, GCP inspections, regulatory science, APEC and ICH related international affairs.Since July 2020, she serves as the Section Chief of New Drug. She is responsible for new drugs, biological products, regenerative medicine registrations, emergency use authorization of COVID-19 vaccines and therapeutic drugs.

Jessie  Lee, MA

Jessie Lee, MA

Director & Head, Patient Recruitment Solutions & Clinical Trial Educator, , IQVIA Asia-Pac, IQVIA, Singapore

Jessie Lee has been in the biopharmaceutical and clinical research industry for 15 years, specifically focused on patient engagement, recruitment, and retention across a wide variety of therapeutic areas since 2015. Jessie leads a team focused on developing data-driven innovations to support accelerated recruitment on trials in Asia-Pacific, while improving site engagement and patient experience working with field-based Clinical Trial Educators.

Aparajeeta  Priyadarasini

Aparajeeta Priyadarasini

Manager Solution Consulting, Medidata, Singapore

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.

Rama  Sethuraman

Rama Sethuraman

Director, Medical Devices, Health Sciences Authority, Singapore

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 10 years now. She received her PhD from the School of Medicine in NUS in 2006. She holds the Professional certification for Regulatory Affairs on Global regulations from the Regulatory Affairs Professional Society (RAPS). She currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF).

Daniel  Tan, MD, MBA

Daniel Tan, MD, MBA

Director, Policy Legislation and Operations, Health Products Regulation Group , Health Sciences Authority, Singapore

Dr Tan is the Director of Policy, Legislation and Regulatory Operations in the Health Sciences Authority Singapore. this encompasses responsibilities in planning and implementing regulatory policies that affect all therapeutic health products in Singapore. He has a MD from University College London.

Varun  Veigas

Varun Veigas

Leader- Policy and Strategic Partnerships, Health Policy and Patient Access,, Roche Diagnostics Asia Pacific Pte. Ltd, Singapore

Varun Veigas is the Regional Regulatory Affairs & Policy Lead, Asia Pacific, Roche Diagnostics, located in Singapore.He is the Chair of the Regulatory Working Group - Digital Health Committee and the China Centre of Excellence- Digital Health Committee at APACMed. A regulatory policy specialist with passion for Digital Health with extensive experience in Medical Devices, In-Vitro Diagnostics, Pharmaceuticals, Biologicals and Vaccines.He interfaces with Ministries of Healthcare, Government Institutions, Regulatory Bodies, Industry Associations, and other key stakeholders for Roche Diagnostics in the Asia Pacific region.

Elodie Baumfeld Andre

Elodie Baumfeld Andre

Head of Real-World Data , Roche, United States

Elodie Baumfeld Andre is the Head of Real-World Data at Roche Information Solutions where she leads a team of quantitative scientists to support the diagnostic product portfolio. Elodie has a PhD in pharmacoepidemiology from the Université de Montréal in Canada, as well as a Master’s in pharmacology and Bachelor’s degree in Physics from UFR Sciences et Techniques in France.

Rosliza  binti Lajis

Rosliza binti Lajis

Head of New Drug Product Section Centre of Product & Cosmetic Evaluation NPRA, Ministry of Health Malaysia, Malaysia

Rosliza Lajis received her pharmacy undergraduate training from the Bandung Institute of Technology, Indonesia in 2001 under Public Service Department Scholarship. Her subsequent higher qualifications were Master in International Health Economics and Pharmacoeconomics from Cardiff University, UK in 2011. She has been servicing the government departments under the Ministry of Health (MoH) for 19 years.In March 2020, she has been appointed as the Head of New Chemical Entity Section in National Pharmaceutical Regulatory Agency (NPRA) Malaysia.

Nina S. Cauchon, PhD, RAC

Nina S. Cauchon, PhD, RAC

Director Regulatory Affairs CMC, Amgen, United States

Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations. Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for ISPE, CASSS, PQRI, AAPS, IQ, and DIA. She is a member of the ISPE International Board of Directors, the PhRMA Global Quality and Manufacturing group, and the ICH Q2(R2)/Q14 Expert Working Group.

Dominique  Lagrave, PharmD

Dominique Lagrave, PharmD

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory Innovation in early 2022 coming from Amgen where he was heading Global Regulatory Operations. As part of his role at Accumulus, Dominique is supporting global Accumulus platform adoption from Health Authorities and Biopharmaceutical organizations. Dominique is also a Board Member of IRISS Forum since 2021 Dominique holds a Pharm D and a master’s in International Regulatory Affairs from the University of Paris.

Mike  Suga

Mike Suga

Senior Staff Director, Business Development – Asia Pacific & Executive Director,, Business Development, CMIC Asia Pacific Pte Ltd, Singapore

Mike is responsible for CMIC’s business development in non-clinical CRO and biologics CDMO areas around Asia Pacific Region. He has been leading CMIC’s corporate partnership with DEVELOPMENT CENTER FOR BIOTECHNOLOGY, Taiwan’s non-profit-organization, for bio-process as well as non-clinical testing collaboration. Mike joined CMIC in 2015 originally to grow its Chicago lab, and after five years in U.S., he is now based in Tokyo at CMIC’s global headquarters. Before joining CMIC, Mike had more than 25 years of R&D and business experience in the life sciences industry at a global medical device company as well as at a Japanese pharma/biotech company.

Miang  Tanakasemsub

Miang Tanakasemsub

Regional head of Commercial quality and Regulatory Affairs, Asia Pacific, Cardinal Health, Singapore

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. She has a board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific including Japan.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.

Jeff  Ten

Jeff Ten

Director Project Management & Delivery Regional Head, Paraxel, United States

Over 18 years of progressive experience in health sciences and Clinical Research Industry. With a significant part of my career in the laboratories from discovery, medical, central to bioanalytical laboratories and project management. Currently oversees and lead the Operation for Clinical Trial Supplies and Logistics team in Asia Pacific. Where we strategize, design and execute the sourcing, packaging, labelling and distribution of Clinical Trial materials. With our own network of GMP certified depots we believe that success to your trial begins with the development of a logistics solution that expedites the delivery of the required supplies to and from your sites, optimizing on the cost, time and effectiveness

John  Richard Thornback

John Richard Thornback

Chief Operating Officer, , Diagnostics Development Hub, Singapore

Currently holds the position of Chief Operating Officer of the Diagnostics Development Hub, the Singapore government initiative focused on driving the growth of the medical diagnostics industry in Singapore. Additionally, he is Chief Quality Officer and Biosafety Officer for the Stronghold Diagnostics Laboratory, a dedicated Covid testing laboratory established by the Singapore Government and Chair of the Centre for Probe Development and Commercialisation, a Canadian National Centre of Excellence, based at McMaster University, Ontario.

Sherry  Wang

Sherry Wang

Principal and Head of Regulatory Commercial Services , IQVIA, Singapore

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.

Matt  Bellgard

Matt Bellgard

Director eResearch, Division of Research and Innovation, Queensland University of Technology, Australia

Professor Bellgard has been awarded >$46m in research funding, co-inventor of patents, and led the design and development of digital health solutions for government, industry and academia. He is Chair of the APEC Rare Disease Network, through multisectoral partnerships to support the ~200 million individuals living with a rare disease.

Suchart  Chongprasert

Suchart Chongprasert

Director, Medicines Regulation Division formerly known as Bureau of Drug Control, Food and Drug Administration (THAILAND), Thailand

Dr. Suchart Chongprasert was graduated his bachelor’s degree science in pharmacy from Chulalongkorn University. He was then as awarded a Royal Thai Government scholarship and earned his doctorate degree from School of Pharmacy, Purdue University, US. He began his professional career in the Food and Drug Administration, Thailand (Thai FDA). He had served several positions in the Thai FDA before he has been promoted to Director, Medicines Regulation Division (formerly known as Bureau of Drug Control) since 1 October 2017.He served as Chairperson of the ACCSQ/PPWG in 2018 and simultaneously has served as Chairperson of the Implementation Working Group under the ACCSQ/PPQG since 2018.

Manan  Hathi

Manan Hathi

Senior Manager, Regulatory Affairs, Styker, United States

Mr. Hathi is a Sr. Regulatory Affairs Manager with responsibility for software and digital health at Stryker. He has over 17 years of experience in the Medical Device space in various roles including Research, Product Development and Regulatory Affairs, with a heavy focus on software based medical devices. He also serves and the software regulatory lead on the corporate product security core team, and plays an important role in the establishment, maintenance and governance of product security policies and procedures for all of Stryker Corporation. Mr. Hathi holds a Master of Science degree in Biomedical Engineering and is Regulatory Affairs Certified (RAC-US) by the Regulatory Affairs Professional Society (RAPS).

Nora  Kleinman

Nora Kleinman

Associate Principal, Real World Solutions, Database Analytics – APAC, IQVIA, United States

Epidemiologist with over a decade of experience across regions and disease areas. Currently leads IQVIA’s regional database analytics team in APAC. Prior, led Evidence Generation for Amgen JAPAC, co-founded a HealthTech startup on diabetes management, and conducted HIV research for US-CDC.

Priscilla  Koh

Priscilla Koh

Director, Regulatory Affairs (Southeast Asia) , Janssen Pharmaceuticals, Medical Devices and Consumer Health, Singapore

Priscilla Koh is the Chairperson of Asia Pacific Medical Technology Association (APACMed) Southeast Asia Center of Excellence, leading country workstreams for each of the 10 ASEAN markets and is the group’s leadership team sponsor for their work in promoting regulatory reliance in the region Trained and registered as a practising pharmacist, Priscilla has over 15 years of experience in healthcare with roles spanning clinical care, regulatory affairs, quality assurance, quality audit and marketing for medical devices, pharmaceuticals and consumer health.

Alicia  Staley, MBA, MS

Alicia Staley, MBA, MS

Vice President, Patient Engagement, Medidata, a Dassault Systèmes Company, United States

Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways. She is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she's applied her engineering background to improve the patient experience for those dealing with cancer.

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