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Type: 14: Posters clear filter
Monday, June 15
 

12:15pm EDT

#418 POS: Student Poster Session I
Monday June 15, 2026 12:15pm - 2:15pm EDT
Component Type: Session

Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
avatar for Kush Amin

Kush Amin

PharmD Candidate, Fairleigh Dickinson University, United States
Kush Amin is a PharmD candidate at Fairleigh Dickinson University College of Pharmacy & Health Sciences with a research focus in pharmacovigilance, managed care pharmacy, and real-world evidence generation. His work examines the intersection of drug safety, regulatory policy, and... Read More →
avatar for Evgeniia Artamonova

Evgeniia Artamonova

Master student, Technical University of Munich, Germany
Evgeniia Artamonova is a Master's student in Health Sciences (Health Prevention and Promotion) at the Technical University of Munich (TUM). She holds a degree in General Medicine (MD) and has a background in epidemiology, global health, biostatistics, and clinical research. Her Master's... Read More →
avatar for Faith Butta

Faith Butta

MS Clinical Research and Product Development, University of North Carolina Wilmington, United States
Faith Butta is a consultant who specializes in federally funded programs in regulatory compliance, program management, and programmatic cross-functional coordination. She has spend the past decade focusing on stakeholder engagement, data integrity, and process improvement. With her... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
TE

TEST Eisenhower

Sr. Exhibit, Sponsorship and Relationship Manager, DIA, United States
avatar for Ellie Froslan

Ellie Froslan

Student, University of Southern California, United States
Ellie Froslan is an undergraduate student at the University of Southern California pursuing a B.S. in Biopharmaceutical Sciences with a minor in Consumer Behavior, alongside a progressive M.S. in Healthcare Decision Analysis. She is a student researcher at the D.K. Kim International... Read More →
MG

Mansi Gupta

none, None, United States
Mansi Gupta is an MS Regulatory Affairs candidate at Northeastern University, Boston, MA, with a bachelor's in Biotechnology Engineering and 2+ years of experience working in QMS and regulatory compliance. At Tolmar Inc., she managed CAPA, deviations, change control, and document... Read More →
avatar for Jackson Hanf

Jackson Hanf

Student, University of Southern California, United States
Jackson Hanf is a B.S./M.S. candidate in Biochemistry and Management of Drug Development at the University of Southern California, where he conducts research in regulatory science and drug development. His work includes building data-driven tools to analyze facilitated regulatory... Read More →
avatar for Alex Juma Ismail

Alex Juma Ismail

PhD Student, University of Hertfordshire, United Kingdom
10+ years in African medicines regulation across national authorities, industry, and harmonisation. Led AUDA-NEPAD’s AMRH pilots on regulatory strengthening & harmonised frameworks. Currently Technical Officer at African Medicines Agency (AMA), supporting continental regulatory... Read More →
avatar for Ali Al Juboori

Ali Al Juboori

Medical Science Liaison, Azurity Pharmaceuticals, United States
TK

TzuYuan Kao

Student, University of Washington, United States
MK

Meghana Karnaty

masters in regulatory affairs, Northeastern University, United States
My name is Meghana Karnaty, and I am currently pursuing a Master of Science in Regulatory Affairs at Northeastern University in Boston, with a concentration in Clinical Research. My academic and professional journey has been shaped by a strong interest in healthcare, patient safety... Read More →
avatar for Bahar Lakeh

Bahar Lakeh

Student, Georgetown University School of Medicine, United States
avatar for Cezar Jr. Manansala

Cezar Jr. Manansala

Student, Centro Escolar University, Philippines
I am a registered Pharmacist who is in his last term of his Master of Science in Pharmacy Degree. I am a consultant to pharmaceutical and medical device companies in Japan. I am very passionate about research and would be very happy to collaborate with different organizations, profit... Read More →
JM

Julia Mauro

Project Specialist, DIA, United States
SP

Shreena Patel

Student Researcher, Massachusetts General Hospital, United States
avatar for Alex Raju

Alex Raju

Founder & Lead Researcher, Chatmedsafe | MS Candidate, LIU, United States
Alex Raju, PharmD, is a Pharmacovigilance (PV) scientist and researcher at the forefront of AI governance and global patient safety. Completing an MS in Drug Regulatory Affairs at Long Island University (LIU), his work leverages 8+ years of industry experience to focus on the compliant... Read More →
avatar for Ekaterina Shipilova

Ekaterina Shipilova

PhD Candidate, The Wistar Institute/The University of Bologna, United States
I am a PhD candidate at the Wistar Institute/University of Bologna joint program. I am a graduate of Pharmaceutical Biotechnology. Previously, I acquired a Bachelor's Degree in the Department of Natural Sciences, with a Major in Biology, a Minor in Physiology, and a thesis in Neurosciences... Read More →
avatar for Yuma Tsuboi

Yuma Tsuboi

PhD student, Waseda Univercity, Japan
Yuma Tsuboi is a regulatory science researcher and doctoral candidate at Waseda University's Cooperative Major in Advanced Biomedical Science. Regulatory science mediates three forces: translating cutting-edge technologies into measurable standards, enhancing predictability for safe... Read More →
avatar for ZIYU YE

ZIYU YE

Graduate Student, University of Macau, China
Ziyu Ye is a second-year master’s student in Medicinal Administration at the University of Macau. She received her bachelor’s degree from The Chinese University of Hong Kong, Shenzhen in 2024. With an interdisciplinary background, her research lies at the intersection of biomedical... Read More →
Monday June 15, 2026 12:15pm - 2:15pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session
 
Tuesday, June 16
 

11:30am EDT

#520 POS: Professional Poster Session II
Tuesday June 16, 2026 11:30am - 1:30pm EDT
Component Type: Session

Professional Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
MB

Melissa Bechtel

Director, Expanded Access Strategy and Process Standards, Pfizer, United States
Melissa Bechtel is Director of Expanded Access, overseeing strategy and process standards for global and local programs that provide timely access to patients with serious or life-threatening conditions. She has worked in Expanded Access since 2015 and continues to expand her exp... Read More →
avatar for Walter Bender

Walter Bender

Chief Scientific Officer, Sorcero, Inc., United States
avatar for Esther Borteye

Esther Borteye

Risk Management Fellow, United States
Esther Borteye, PharmD, is a graduate of the University of Tennessee and currently serves as a Risk Management Fellow at Pfizer. She supports pharmacovigilance activities and Risk Evaluation and Mitigation Strategies across therapeutic areas, including assessing safety data, contributing... Read More →
JC

Joan Cheung

Principal Consultant, Epista Life Science, United States
Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →
LC

Linda Chiou

Senior Manager Medical Information, LEO Pharma, United States
Linda Chiou is a Senior Medical Information Manager at LEO Pharma with more than 20 years of pharmaceutical industry experience. She is passionate about advancing Med Info through innovative uses of technology and AI to improve day-to-day operations, communication, and engagement... Read More →
AC

Adam Clarke

Innovation Manager, Bristol Myers Squibb, United States
Adam Clarke works on the Patient Safety Evolution team at Bristol Myers Squibb. He seeks to enhance collaboration, develop AI enabled safety, and develop digital health approaches that illuminate benefit–risk in new ways. He holds dual BS degrees in Chemistry and Biology and began... Read More →
avatar for Viviana Coppo

Viviana Coppo

IRB Principal Chair, WCG, United States
Viviana Coppo is a licensed pharmacist in the U.S. and Europe, with a Doctor of Pharmacy degree from the University of Turin. She has a strong background in the pharmaceutical industry, clinical research, and community pharmacy. She has over 20 years of experience in cross-functional... Read More →
avatar for Vamsidhara Dhulipala

Vamsidhara Dhulipala

Senior Director, Global Regulatory Affairs at GSK, GSK, United States
Vamsi currently works as a Senior Director, Regulatory Affairs at GSK. Prior to that Vamsi worked as a Director/Senior Director, Regulatory Affairs from 2013 to 2022 and as a toxicologist from 2004 o 2013 at Merck Research Labs. He has experience with all phases of drug development... Read More →
JD

John Diaz-Decaro

Founder, Black Swan Causal Labs, United States
John D. Diaz-Decaro, PhD, MS is a pharmacoepidemiologist and real-world evidence strategist with expertise in real-world evidence, observational study design, and AI-enabled evidence generation. He served as Senior Director and Lead Epidemiologist at ModernaTX, directing a global... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Principal Consultant, Decision Analytics, United States
Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory... Read More →
avatar for Karen Hinkle

Karen Hinkle

Associate Director, Medical Writing, Boehringer Ingelheim , United States
Karen Hinkle, Ph.D., is Associate Director of Medical Writing at Boehringer Ingelheim where she specializes in developing patient-facing regulatory documents for clinical trials, including Informed Consent Forms. She has a PhD in Physiology from the University of Michigan with a research... Read More →
avatar for Neda Jiveh

Neda Jiveh

Medical Information and Review Fellow, Pfizer, United States
avatar for MIDHUN RAJ K

MIDHUN RAJ K

Associate Director, Signal Management, IQVIA, India
Pharmacovigilance professional, with bachelor's in pharmacy and master's in data sciences with 15+ years of working experience in drug safety surveillance industry with a special focus on its quality management aspects. Worked with number of pharmaceutical, biological and medical... Read More →
RK

Rohit Kadam

Researcher, TCS ADD, TATA CONSULTANCY SERVICES LIMITED, INDIA, India
EK

Edward Kim

Analyst, FDA, United States
Edward is a clinical safety and surveillance research liaison and senior reviewer in the Office of Generic Drugs. He conducts and develops research and multifunctional projects to study drug safety and data-driven public health improvements. Prior to his nearly 17 years at FDA, Edward... Read More →
avatar for Hyeonmin Kwon

Hyeonmin Kwon

Assistant Manager, Korea Institute of Drug Safety and Risk Management (KIDS), Korea, Republic of
Hyeonmin Kwon is currently working at the Korea Institute of Drug Safety & Rist Management(KIDS) as a pharmacist. She earned a bachelor's degree in Pharmacy from Kangwon National University. Currently, she is part of the Office of ADR Relief, engaged in the causality assessment of... Read More →
avatar for Joseph Laudano

Joseph Laudano

Medical Director, IQVIA, United States
Joseph B. Laudano BS Pharm, Pharm D – Medical Director, IQVIA Inc. Joe has over 35 years’ experience in Pharma. Before joining IQVIA, he was VP, Medical Affairs at Pharmaspectra, VP Medical Affairs at Alliqua Biomedical and Senior Director of Medical Affairs & Global Head of Publication... Read More →
SL

SAMIR LEDADE

ASSOCIATE DIRECTOR, Alexion Pharmaceuticals, Canada
Samir Ledade is an Associate Director, Medical Writing Operations at Alexion Pharmaceuticals, based in Mississauga, Canada. He has over 16 years of experience in regulatory medical writing, clinical development, and pharmacovigilance within global pharmaceutical organizations. His... Read More →
PL

Po-Hung Lee

Associate Reviewer, Taiwan's Food and Drug Administration (TFDA), Taiwan
avatar for Ji Li

Ji Li

Reviewer, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Ji Li is a primary reviewer at the Division of Clinical Outcome Assessment at the U.S. FDA. Dr. Li reviews the use of clinical outcome assessments in IND/NDA/BLA applications that are intended to support labeling claims of medical product development programs. Dr. Li also reviews... Read More →
LL

Linghui Li

Associate Director, Takeda, United States
avatar for Anran Liu

Anran Liu

ORISE Postdoctoral Fellow, FDA, United States
Anran is a postdoctoral fellow at the U.S. FDA, CDER Office of Surveillance and Epidemiology, conducting research in pharmacovigilance and drug safety surveillance. She earned her PhD in Biostatistics from SUNY Buffalo in August 2024, where she developed approaches for adverse event... Read More →
avatar for ChiaPing Liu

ChiaPing Liu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Ms. Liu has received her bachelor degree in pharmacy from Taipei Medical University and later acquired her pharmacist certificate. She has received her master degree in Law from National Cheng Chi University. She has been serving in Taiwan Food and Drug Administration (TFDA) these... Read More →
KM

Kristi Malone

Lay Language & New Media Medical Writer, Boehringer Ingelheim, United States
Kristi is a lay language medical writer at Boehringer Ingelheim. She specializes in plain language regulatory writing including authoring informed consent documents. Kristi has more than 20 years of clinical trial experience in the pharmaceutical industry.
JM

Julia Mauro

Project Specialist, DIA, United States
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA, United States
Kristen Miller is a Health Scientist Policy Analyst with the Office of Medical Policy (OMP) at the U.S. Food and Drug Administration (FDA), where she manages Real-World Evidence (RWE) Analytics for the Center of Drug Evaluation and Research (CDER). She oversees public-private collaborations... Read More →
avatar for Namareq Musa

Namareq Musa

Post-Doctoral Fellow, Pfizer, United States
PharmD graduate and a first-year U.S. Medical Information Post-Doctoral Fellow at Pfizer in Heme/Onc
avatar for Carolina Navas

Carolina Navas

COA Manager, IQVIA, Spain
I am an oncology scientist with training as a medical veterinarian and a PhD in Biochemistry and Molecular Biology, with over a decade of experience across academia and industry in Europe and the United States. I have contributed to multiple high-impact publications in oncology and... Read More →
JN

Jonathan Norman

Director, Localization & Scale Management, YPrime Inc., United Kingdom
IN

Isaac Nyarko

Senior Manager, Regulatory Affairs, Advertising and Promotion, Merz Aesthetics, United States
Isaac Nyarko, MS, MPH, is a Senior Manager of Regulatory Affairs, Advertising and Promotion, specializing in ad-promo compliance for pharmaceuticals and medical devices in the U.S. and Canada. He is currently pursuing a Doctorate in Regulatory Science at the University of Southern... Read More →
avatar for Feisal Othman

Feisal Othman

Benefit Risk Assessment Lead, Bristol Myers Squibb, United States
Feisal Othman is a drug safety and benefit–risk assessment professional with over 15 years of experience across healthcare, patient safety, and regulatory science. He currently serves as a Benefit Risk Assessment Lead at Bristol Myers Squibb, where he leads the development and application... Read More →
avatar for Sahishnu Patel

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States
Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →
AP

Amit Patel

CEO, Octozi, United States
Amit Patel is the co-founder and CEO of Octozi, an AI company automating clinical data workflows for pharma sponsors. Previously he was a product leader at GoogleX and Meta developing new AI platforms. He is a graduate of Stanford University and lives in New York City.
avatar for Su Qiu

Su Qiu

Director, Head of Medical Translation, Beone Medicines, China
Dr. Su Qiu is Director and Head of Medical Translation at BeOne Medicines. With over 15 years of experience in medical translation, Dr. Su has delivered high-quality simultaneous interpretation at more than 2,000 international medical conferences. She built BeOne Medicines’ in-house... Read More →
avatar for Mohit Raizada

Mohit Raizada

Director - Signal Management Services, IQVIA, India
Dr. Mohit Raizada is the Director and Head of Signal Management Services in the Lifecycle Safety department at IQVIA, India. He is an expert in signal management and has successfully onboarded, led, executed, and completed complex signal management projects for various companies... Read More →
AR

Anuradha Roy

Senior Vice President, One Vector, United States
A seasoned leader with 25+ years of experience advising clients on creating value through business transformation leveraging technology while keeping focus on compliance and quality. Anu started her career as a product manager, collaborating with different departments on scaling up... Read More →
avatar for Takahiro Sakai

Takahiro Sakai

Chief, Clinical Research Coordinating Section, National Cancer Center Hospital, Japan
JOB EXPERIENCE: April/2011 to present National Cancer Center Hospital East JAPAN(NCCHE) /Clinical Trial Management Office/Clinical Research Coordinator(CRC), chief EDUCATION: Master of Pharmacy QUALIFICATIONS: Association of Clinical Research Professionals(ACRP) certified CRC
ST

Steven Thompson

Founder, Nextrial AI, Brazil
CU

Chansonida Uk

Post-Doctoral Medical Affairs Fellow, CSL Seqirus/Northeastern University, United States
Chansonida J. Uk, PharmD, is a Post-Doctoral Medical Affairs Fellow at CSL Seqirus with over three years of experience across Medical Affairs, public health, and HealthTech. She has a strong background in immunology and vaccine science, supporting Medical Information, publications... Read More →
avatar for Yukino Umeki

Yukino Umeki

Reviewer (Biostatistics), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
RV

Rishi Verma

Medical Director, Roche & Stethy, Australia
Rishi is a Physician and medical director who worked in the Life science industry. He has led and supervised various Clinical Trial programs across the world. Rishi is also the Director of Stethy an AI automation platform for the life science to improve safety and compliance across... Read More →
KY

Khaled Yahiaoui

Associate Director, Regulatory Affairs- Operations, Merck & Co., Inc., Canada
Khaled is Associate Director, Regulatory Operations at Merck Canada, with 16 years' experience in regulatory operations. He specializes in global electronic regulations, holds a Regulatory Affairs Certification from RAPS, and lectures on electronic submissions at the University of... Read More →
avatar for Takayuki Yasuda

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
Takayuki Yasuda has been serving as a Statistical Programmer in the Biometrics department at Chugai Pharmaceutical Co., Ltd. since 2020. He worked in the CRO industry from 2014 to 2020. Since 2024, he has been leading an initiative on implementing generative AI in the clinical development... Read More →
Tuesday June 16, 2026 11:30am - 1:30pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session
 
Wednesday, June 17
 

11:30am EDT

#617 POS: Professional Poster Session III
Wednesday June 17, 2026 11:30am - 1:30pm EDT
Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
SA

Sharad Adekar

Senior Medical Chair, WCG, United States
Sharad Adekar, MD, PhD, CIP, is a Senior Medical Chair at WCG. He is a physician scientist with clinical experience in family practice and pediatrics and research experience in immunology, oncology, cardiovascular diseases, infectious diseases, and neurology. Dr. Adekar has experience... Read More →
avatar for Anna-Marika Bauer

Anna-Marika Bauer

Regulatory Specialist II, Critical Path Institute, United States
Anna-Marika Bauer is a regulatory specialist with the Regulatory Science program at the Critical Path Institute (C-Path). She received her undergraduate degree in Neuroscience from Franklin & Marshall College and her Master of Regulatory Affairs from the University of Pennsylvania... Read More →
avatar for Priyanka Bobbili

Priyanka Bobbili

Vice President, Analysis Group, Inc., United States
Dr. Bobbili specializes in the application of statistical methods for the causal analysis of complex longitudinal data. She has a wide range of experience in epidemiology and outcomes research, including studies on causal methods, drug adherence and comparative-effectiveness, particularly... Read More →
avatar for Rose Chang

Rose Chang

Vice President, Analysis Group, Inc., United States
Dr. Chang is an epidemiologist specializing in outcomes research and the application of advanced methods to generate real-world evidence (RWE) on unmet medical need, treatment patterns, and drug safety and effectiveness. She has experience across therapeutic areas using diverse health... Read More →
avatar for Susan Chong

Susan Chong

Senior Manager, Global Regulatory Policy and Intelligence, Amgen, United States
Susan Chong is Senior Manager, Global Regulatory Policy and Intelligence at Amgen, where she is responsible for the global regulatory commenting process on draft guidance documents, proposed rules and legislation, and more. Prior to this role, she was a Senior Associate Regulatory... Read More →
avatar for Grace Collins

Grace Collins

Manager, Regulatory & Data Insights, Friends of Cancer Research, United States
Grace Collins is Manager of Regulatory & Data Insights at Friends of Cancer Research. She leads the development of public data dashboards that track trends in oncology drug development and clinical trials. Her work focuses on analyzing regulatory and policy trends to inform science... Read More →
avatar for Lorraine Danks

Lorraine Danks

Senior Program Officer, Gates Foundation, South Africa
After spending 22 years in the pharmaceutical industry in regulatory affairs, QA and PV roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, Lorraine Danks joined the South African medicines regulator, SAHPRA, in June 2020 to head up the organization’s... Read More →
avatar for Mei Sheng Duh

Mei Sheng Duh

Managing Principal, Analysis Group, Inc., United States
Dr. Mei Sheng Duh, M.P.H., Sc.D., is a Managing Principal and Chief Epidemiologist at Analysis Group. She specializes in decision-grade real-world evidence (RWE) to support product registration, post-approval safety and effectiveness studies, and health technology assessments of pharmaceuticals... Read More →
avatar for Motoki Fujii

Motoki Fujii

Exective Professional, EPS Group, Japan
[Expertise] Medical device regulatory consultant Support for the creation of medical device regulatory-related materials Strategy planning and support for face-to-face advice provided by PMDA Correspondence with overseas clients [Career] After joining EPS in 2008, engaged in consulting... Read More →
avatar for BI-KAI HSU

BI-KAI HSU

Senior Project Manager, Center For Drug Evaluation, Taiwan, Taiwan
I received my Master’s degree in Pharmacology from National Yang-Ming University, Taiwan. I began my career at the Taiwan Food and Drug Administration (TFDA) through alternative military service, where I gained foundational experience in regulatory review. I later worked in the... Read More →
KK

Kaili Kulbacki

Clinical Research Professional, Solaire Solutions, United States
HK

Houshen Kuo

reviewer, Taiwan Food and Drug Administration, Taiwan
avatar for Eui-Kyung Lee

Eui-Kyung Lee

Professor, School of Pharmacy, SKKU (sungkyunkwan University), Korea, Republic of
Dr. Eui-Kyung Lee is Professor of Pharmaceutical Policy and Outcomes Research at Sungkyunkwan University, South Korea. She served as Minister of the Ministry of Food and Drug Safety (2019–2020), leading emergency authorizations for COVID-19 diagnostics and fast-track approvals of... Read More →
avatar for Carmen Lin

Carmen Lin

Global Regulatory Affairs Content Strategist Specialist, Roche, Canada
Carmen is a Global Regulatory Content Specialist focusing on regulatory strategy at Roche. A graduate of the University of Toronto’s PharmD program (2023), she maintains her clinical expertise as a registered pharmacist. She has extensive experience in labeling, program management... Read More →
avatar for ChiaPing Liu

ChiaPing Liu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Ms. Liu has received her bachelor degree in pharmacy from Taipei Medical University and later acquired her pharmacist certificate. She has received her master degree in Law from National Cheng Chi University. She has been serving in Taiwan Food and Drug Administration (TFDA) these... Read More →
avatar for Arun Mathew

Arun Mathew

Director, AbbVie, United States
Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.
JM

Julia Mauro

Project Specialist, DIA, United States
avatar for Yuki Miyatake

Yuki Miyatake

Sr Group Manager, Eli Lilly and Company, Japan
Yuki Miyatake is a Senior Group Manager of Policy and Excellence at Eli Lilly Japan KK, specializing in regulatory policy strategy and intelligence. Driven by his personal experiences as a former patient, Yuki is passionate about fostering an innovative regulatory environment that... Read More →
avatar for Satchell Mede Pacheco

Satchell Mede Pacheco

Medical Affairs Strategy Fellow, Rutgers Univerity, United States
Satchell Mede Pacheco, PharmD is a Medical Affairs Strategy professional focused on roles at the intersection of scientific rigor, commercial insight, and patient impact. She is motivated by shaping strategies that expand access to innovation, strengthen evidence generation, and elevate... Read More →
VP

Vihanga Pahalawatta

Director Regulatory Affairs, AbbVie, United States
Vihanga Pahalawatta has over 10 years of industry experience related to In Vitro Diagnostic (IVD) products and Companion Diagnostics (CDx) in Research and Development and Regulatory Affairs. In her current role at AbbVie, Vihanga leads the CDx device regulatory group, guiding teams... Read More →
JP

Jami Peters

Associate Director, Gilead Sciences, United States
I’m a pharmacoepidemiologist with 13 years of experience in the biotechnology industry. My background includes five years in drug safety operations, which continues to strongly inform my current work. I bring hands-on experience with real-world evidence to support pharmacovigilance... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
avatar for Patrick Rodriguez

Patrick Rodriguez

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Patrick Rodriguez is a Policy Analyst at the Duke-Margolis Institute for Health Policy on the Biomedical Innovation team. He primarily supports projects under the FDA and Real-World Evidence portfolios. He holds a MA in Bioethics and Science Policy with concentrations in both technology... Read More →
GR

Gargi Roy

Regulatory Affairs Associate, Servier Canada, Canada
I am a Regulatory Affairs Professional with a Bachelor's degree in Pharmacy and a Masters in drug Development specializing in Regulatory Affairs. With over 4 years of experience in Regulatory affairs and previous experience in Quality Assurance, I have expertise in pharmaceutical... Read More →
HS

Harsh Shah

CoFounder and CEO, Clinplex, United States
Harsh Shah is Co-Founder and CEO of Clinplex, an AI regulatory intelligence company focused on continuous compliance assessment for pharmaceutical, biotech, and medical device organizations. He brings 16+ years of pharmaceutical Quality Assurance and Regulatory Affairs experience... Read More →
JS

Jennifer Shelton

Solution Executive, Actalent, United States
Clinical Operations and Solution Executive at Actalent with 16+ years of experience leading global Phase I–IV clinical trials across Oncology, CNS, Rare Disease, vaccines, Infectious and Dermatologic Diseases, CAR-T, Medical Device, and preventive and therapeutic programs. Partners... Read More →
avatar for Molly Shields

Molly Shields

Policy Analyst, Assistant, Duke-Margolis Institute For Health Policy, United States
Molly Shields is a Policy Analyst, Assistant on the Biomedical Innovation team at Duke-Margolis where she supports the Institute's work on clinical trials, real-world evidence, and U.S. Food and Drug Administration cooperative agreements. During her undergraduate career, she conducted... Read More →
avatar for Ayoub Suliman

Ayoub Suliman

Regulatory Health Project Manager, FDA, United States
I am a Regulatory Health Project Manager with FDA/CDER's Office of Medical Policy (OMP). In my current role, I support policy development activities for OMP's innovation portfolio including Digital Health Technologies, Real-World Evidence, and Artificial Intelligence programs. I also... Read More →
avatar for Amisha Tayal

Amisha Tayal

Regulatory Labeling & Advertising/Promotion Fellow, Pfizer, United States
Amisha Tayal, PharmD, MBA is a Regulatory Labeling and Advertising & Promotion Fellow at Pfizer through the Howard University postdoctoral fellowship program. In her role, she supports cross-functional stakeholders on U.S. labeling strategy, regulatory submissions, and advertising... Read More →
KB

Khim Boon Tee

Senior Principal Assistant Director, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Malaysia
Dr. Tee Khim Boon is a regulatory expert specializing in GCP and BE inspections. She contributes to Malaysia’s NPRA, ensuring data integrity across borders. Between 2014 and 2023, she led oversight missions in India, Taiwan, Thailand, Indonesia, and Romania . Over the past three... Read More →
avatar for Katherine Toran

Katherine Toran

Economist, FDA, United States
Katherine Toran serves as Economist at the Food and Drug Administration, specializing in prescription drugs. Katherine holds a PhD in Economics from University of Kentucky.
avatar for Apurva Uniyal

Apurva Uniyal

Regulatory Innovation Research Scientist, The DK Kim International Center, Department of Regulatory and Quality Sciences,, United States
Apurva Uniyal, MA, MS, is a Regulatory Innovation Research Scientist at the D.K. Kim International Center for Regulatory Science. With an MS from USC and over 20 years of experience in clinical and regulatory research, she brings both academic and practical expertise to her role... Read More →
JW

Jun-Fon Wang

Senior Clinical Reviewer, The Center For Drug Evaluation (CDE), Taiwan, Taiwan
Multidisciplinary pharmaceutical expert with a solid foundation in clinical pharmacy and extensive experience in regulatory strategy, clinical review, and global drug development. Specialized in benefit–risk assessment of NDA/BLA and IND submissions, post-approval efficacy/safety... Read More →
avatar for Mia Williams

Mia Williams

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
avatar for Meng-Hsiu Wu

Meng-Hsiu Wu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Wednesday June 17, 2026 11:30am - 1:30pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session
 
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