Symposium 8: Post-market surveillance of medicines,vaccines and medical devices across the Asia-Pacificregion: The next 10 Years
Moderators
Edward Chia-Cheng Lai, National Cheng Kung University, Taiwan
Dr. Edward Lai is an Assistant Professor for School of Pharmacy, Instituteof Clinical Pharmacy and Pharmaceutical Sciences, at National Cheng
Kung University in Taiwan. His research interests include drug safety,
comparative
effectivenessandinternational
multi-databases
pharmacoepidemiologic studies. He was a chair of the Asian
Pharmacoepidemiology Network, and currently works on international
projects for psychiatric medications, biologic agents as well as oncologictreatments. He receives governmental grants for developing
pharmacoepidemiologic and analytic methods to protect data privacy for
multiple databases studies. He is also working with Taiwan Drug Relief Foundation to improvedrug safety, signal detection and post-marketing surveillance using electronic healthcare
databases.
Nam-Kyong Choi, Ewha Womans University, South Korea
Nam-Kyong Choi is an Associate Professor of the Department of HealthConvergence, College of Science & Industry Convergence at Ewha
Womans University in Seoul, South Korea. She received her B.S. in
Pharmacy from Ewha Womans University and M.Sc. and Ph.D.
in Pharmacoepidemiology from the Seoul National University College ofMedicine. She had been worked as a Visiting Professor in the Division of
Pharmacoepidemiology Pharmacoeconomics, within the Department ofMedicine at Brigham and Women’s Hospital and Harvard Medical Schoolfrom 2015 to 2017.
She is a chair-elect of Asian Pharmacoepidemiology Network (AsPEN), a director of theInternational Cooperation Committee in Korean Society for Pharmacoepidemiology and Risk
Management, and a member of Editorial Board in Korean Academy of Social & Managed CarePharmacy. She has been an associate editor of Pharmacoepidemiology and Drug Safety, theofficial journal of ISPE since 2010. She is Advisory Committee Members of the Drug Safety
Evaluation and the Social Relief Scheme for Serious Adverse Drug Reactions for the Korea
Institute of Drug Safety and Risk Management.
Her area of research focuses on the development and application of epidemiologic andstatistical methods for evaluating the safety and comparative effectiveness of medical
products in large health databases.

Kenneth Man, University College London, UK; University of Hong Kong, Hong KongKenneth is currently a Maplethorpe Fellow at the Research Departmentof Practice and Policy, UCL School of Pharmacy, London. He is also
current chair of Asia Pharmacoepidemiology Network (AsPEN), acollaborative network on medication safety and pharmacoepidemiology
research across the Asia-Pacific region. With expertise in medication
research with electronic health care databases and novel epidemiologicalmethodologies, his work encompassed research in Paediatric andPsychiatric Pharmacoepidemiology in particular treatment forneurodevelopmental disorders. He receives the CW MaplethorpeFellowship in Pharmacy to investigate the safety of psychotropic medications use inpregnancy.

Speakers
Nam-Kyong Choi, Ewha Womans University, South Korea
Nam-Kyong Choi is an Associate Professor of the Department of HealthConvergence, College of Science & Industry Convergence at Ewha
Womans University in Seoul, South Korea. She received her B.S. in
Pharmacy from Ewha Womans University and M.Sc. and Ph.D.
in Pharmacoepidemiology from the Seoul National University College ofMedicine. She had been worked as a Visiting Professor in the Division ofPharmacoepidemiology Pharmacoeconomics, within the Department ofMedicine at Brigham and Women’s Hospital and Harvard Medical Schoolfrom 2015 to 2017.
She is a chair-elect of Asian Pharmacoepidemiology Network (AsPEN), a director of theInternational Cooperation Committee in Korean Society for Pharmacoepidemiology and Risk
Management, and a member of Editorial Board in Korean Academy of Social & Managed Care
Pharmacy. She has been an associate editor of Pharmacoepidemiology and Drug Safety, theofficial journal of ISPE since 2010. She is Advisory Committee Members of the Drug Safety
Evaluation and the Social Relief Scheme for Serious Adverse Drug Reactions for the KoreaInstitute of Drug Safety and Risk Management.
Her area of research focuses on the development and application of epidemiologic andstatistical methods for evaluating the safety and comparative effectiveness of medical
products in large health databases.
Ju-Young Shin, Sungkyunkwan University, South Korea
Dr. Ju-Young Shin is a current assistant professor at school of pharmacy,
SungKyunKwan University (SKKU). She also serves as an associate
editor of Pharmacoepidemiolgoy and Drug Safety (PDS). She received
her B.S. in pharmacy from Seoul National University, MPH in health policyand Ph.D. in pharmacoepidemiology from the Seoul National University
College of Medicine. She was a visiting fellow at university of South
Australia, and postdoctoral fellow at McGill University. She publishedmore than 90 peer-reviewed journal and published her study in British
Medical Journal (BMJ), twice, regarding the safety of antidepressants andADHD medication using 50 million Korean healthcare database. Her areaof research is a safety of psychotropic drugs, vaccine safety, methodology development, anddrug utilization review in the frail population. She is leading or co-leading several projects
sponsored by Korea Ministry of Food and Drug Safety, Ministry of Health and Welfare, Centerfor Disease Control and Prevention, National Research Foundations, and Pharmaceuticalcompanies. She was a past-team director at Korea Institute of Drug Safety and Risk
Management (KIDS) and led several epidemiological studies. She is now in charge of vicedirector in one of Korean regional pharmacovigilance center- pharmacist association. She also

serves as a consultant for several Korean governmental committee including national
evidence-based collaborating agency (NECA), and KIDS. She has been a member ofInternational Society for Pharmacoepidemiology (ISPE) since 2007, and is currently a memberof board of directors of Korea society of Pharmacoepidemiology and Risk Management(KoPERM), Korea society of epidemiology, and Korea academy of social and managed carepharmacy.
Nicole Pratt, University of South Australia, Australia
Dr Nicole Pratt is an Associate Professor and Deputy Director of theQuality Use of Medicines and Pharmacy Research Centre, Sansom
Institute, University of South Australia. She is a member of the Drug
Utilisation Subcommittee (DUSC) of the Australian Department of HealthPharmaceutical Benefits Advisory Committee (PBAC). Nicole leads theevaluation of the Department of Veterans Affairs, Veterans’ Medicines
Advice and Therapeutics Education Service (Veterans’ MATES) program
which uses administrative claims data to develop and evaluate
interventions to improve use of medicines in the veteran population inAustralia. She is a past-chair of the Asian Pharmacoepidemiology
Network (AsPEN) initiative (www.aspennet.asia) and a collaborator of Observational Health andData Sciences and Informatics (www.ohdsi.org) which aims to bring out the value of healthdata through large-scale analytics.
Gianluca Trifirò, University of Messina, ItalyGianluca Trifirò is MD, with Post-Gaduation Degree in ClinicalPharmacology (University of Messina, Italy), Master of Science in Clinical
Epidemiology (NIHES, NL) and PhD in Pharmacoepidemiology(Erasmus Medical Center, Rotterdam, NL). Associate Professor ofPharmacology (with qualification for Full professor) and ClinicalPharmacologist at the Academic Hospital of Messina. Scientificcoordinator of an Academic Master program on “Use of Real-world datafor evaluations in Pharmacovigilance, Pharmacoepidemiology andPharmacoeconomics” at University of Messina.
Clinical pharmacologist of Phase I Clinical Trial Unit of Bambino GesùPediatric Hospital of Rome (Italy).
Member of editorial board of Drug Safety and Pharmacoepidemiology and Drug Safety.
Member of Steering Group of European Network of Centres for Pharmacoepidemiology andPharmacovigilance (ENCePP®) at the European Medicine Agency. Chair of the WorkingGroup (WG) on methodological approaches for multisource studies of ENCePP. Chair of theLocal Organizing Committees for the mid-year meetings of ISPE (Florence, April 2011; Rome,April 2019) and component of Local Organizing Committee of the International Society ofPharmacovigilance annual meeting (Pisa, 2013). Chair of the Biologics/Biosimilar Special
Interest Group of ISPE. Member of Scientific Committee of Pharmacovigilance Office of ItalianDrug Agency; chair of Italian Society of Pharmacology WG on Pharmacovigilance andPharmacoepidemiology.
Mary-Beth Ritchey FISPE, RTI Health Solutions, USAMary Beth Ritchey is the Director, Epidemiology, Medical Devices & RealWorld Evidence at RTI-HS. In her role, Dr. Ritchey performs and oversees
the scientific, technical, and logistic aspects of projects, including conductof prospective and retrospective non-interventional safety, effectiveness,and utilization studies; registry governance and implementation;assessment of the regulatory landscape and study portfolio planning for
novel therapeutics and rare diseases; and consultation on timing, design,and practical application of methods for real-world studies. Prior to joining
RTI-HS, Dr. Ritchey’s career spanned government and industry. During

her tenure at the US FDA, she managed the device Postmarket Surveillance Studies program
and was involved with the Medical Device Epidemiology Network and Sentinel initiatives. At
Merck, she developed data strategy tools, collaborations, and a continuous learningorganization for Comparative and Outcomes Evidence. At Procter & Gamble, she enhanced
the signal and risk management programs to include synthesis and interpretation acrossmultiple disparate data sources. She obtained her masters and doctorate degrees in
Epidemiology from the UNC Gillings School of Global Public Health and holds an adjunctfaculty appointment in the Center for Pharmacoepidemiology and Treatment Science atRutgers University.