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AH

Amber Hill

R.grid, United Kingdom
Founder & CEO
HH

Hideki Hiraoka

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer
MH

Michal Hirsh-Vexberg

Israel Ministry of Health, Israel
Head of the Pharmaceuticals Registration Department, Medical...
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Uppsala Monitoring Centre, Sweden
Director/CEO
avatar for Martin Hodosi

Martin Hodosi

Kearney, United Kingdom
Partner, Healthcare and Life Sciences Practices
avatar for Eimy Honda

Eimy Honda

University of São Paulo - USP, Brazil
avatar for Cindy Hoots

Cindy Hoots

AstraZeneca, United States
Chief Digital Officer and Chief Information Officer
avatar for Paula Horowitz

Paula Horowitz

AbbVie, United States
Program Manager, QA, GCP Software Validation
avatar for Ryan Hoshi

Ryan Hoshi

AbbVie, United States
Director, Regulatory Policy and Intelligence
PH

Philip Hougaard

Lundbeck A/S, Denmark
Vice President, Biostatistics and Data Science
avatar for François Houyez

François Houyez

European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
avatar for Brett Howard

Brett Howard

USP, United States
Senior Director, US Regulatory Policy
EH

Endang Hoyaranda

Indonesian Association For the Study of Medicinals (IASMED), Indonesia
President
avatar for Alice Hsu

Alice Hsu

Amgen Inc., United States
Director Integrated Signal Management
avatar for Angela Hu

Angela Hu

PAREXEL International Inc., Taiwan
VP
avatar for Li Huang

Li Huang

Phastar, United States
Principal Biostatistician
avatar for Tse-Yin Huang

Tse-Yin Huang

Center for Drug Evaluation, Taiwan, Taiwan
Reviewer
WH

Wei-I Huang

Taiwan Drug Relief Foundation, Taiwan
Director, Division of Drug Safety
avatar for Laura Huggins

Laura Huggins

Merck KGaA (EMD Serono), Germany
VP & Head, Global Regulatory Affairs Oncology & CDx
avatar for Melissa Hunt

Melissa Hunt

Health Canada, Canada
Director
BH

Brian Hunter

CNS Healthcare, United States
Vice President of Contracts and Trial Management
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Parexel , United States
Chief Patient Officer
CH

Campbell Hutton

Breakthrough T1D, United States
Senior Vice President, Global Advocacy
avatar for Huong Huynh

Huong Huynh

Critical Path Institute, United States
Director of Regulatory Science
TH

Tran Huynh

Fortrea, United States
Director, Clinical Vendor Strategy
AH

Anna Hyde

Arthritis Foundation, United States
Vice President of Advocacy & Access
avatar for TAE HYUN

TAE HYUN

FDA, United States
Senior Statistical Reviewer, CDER
avatar for Edward Ian

Edward Ian

Mediscience Planning Inc., Japan
Head of Integrated Innovation Service Center
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Pfizer Inc, United States
Senior Director, Safety Risk Management Lead
SI

Sameera Ibrahim

Bristol Myers Squibb, United Kingdom
Head of Risk Governance & Operations, R&D Quality
KI

Kentaro Ichinose

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspector
TI

Taruna Ikrar

Indonesia Food and Drug Authority, Indonesia
Chairperson
avatar for William Illis

William Illis

Novartis , United States
Global Head, Collaboration/Technology Strategy, Clinical Development...
avatar for Anne Marie Inglis

Anne Marie Inglis

GSK, United States
Senior Director, Clinical Operations Asset Lead
EI

Elizabeth Iorns

CEO and Co-Founder, United States
Science Exchange
MI

Maxwell Isaacoff

Elevance Health, Inc, United States
Director, Federal & External Affairs
AI

Akihiro Ishiguro

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug III
avatar for Md Rashedul Islam

Md Rashedul Islam

Queensborough Community College, United States
Undergraduate Research Scholar
DI

David Isom

Pfizer Inc, United States
Senior Director, Global Regulatory Policy and Intelligence, Global...
avatar for Aarthi Iyer

Aarthi Iyer

Cogent Biosciences, Inc., United States
Corporate Counsel
CJ

Charles Jaffee

HL7, United States
Chief Executive Officer
avatar for Nabeela Jahangeer

Nabeela Jahangeer

University of Southern California, United States
Student
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

LifeSciHub , United States
Drug Development Multi-Functionalist
TJ

Tony Johnson

Mallinckrodt Pharmaceuticals, United States
Senior Director, Clinical Quality
avatar for Jeremy Jokinen

Jeremy Jokinen

Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
avatar for Brad Jordan

Brad Jordan

Eli Lilly and Company, United States
Associate Vice President, Regulatory Policy and Strategy
KW

Ken Wiley. Jr.

National Center For Advancing Translational Sciences, United States
Section Chief
TJ

Tom Julian

Gilead Sciences, United States
Assoc. Director Design and Innovation
ZJ

Zhanna Jumadilova

Pfizer Inc, United States
Clinical Lead
avatar for Patricia Jumelle

Patricia Jumelle

University of Southern California, United States
Student
HJ

HYUN JOO JUNG

Korea Institute of Drug Safety & Risk Management, Korea, Republic of
Departiment of Drug Safty Information
avatar for Andrea Jux

Andrea Jux

Genmab US, Inc., United States
Senior Director, Development Program Management
avatar for MIDHUN RAJ K

MIDHUN RAJ K

IQVIA, India
Manager, Signal Management
avatar for Rasika Kalamegham

Rasika Kalamegham

Genentech, A Member of the Roche Group, United States
Head, US Regulatory Policy
avatar for Linda Kalilani

Linda Kalilani

GlaxoSmithKline, United States
Senior Director and Head of Oncology Epidemiology
avatar for Joseph Kannarkat

Joseph Kannarkat

Johns Hopkins University School of Medicine, United States
Physician
avatar for Chris Karlovich

Chris Karlovich

Leidos Biomedical Research, United States
Director, Molecular Characterization Laboratory
SK

Stephen Karpen

Breakthrough T1D, United States
Senior Director, Regulatory Affairs
EK

Elaine Katrivanos

Tempus AI, United States
Senior Director Regulatory Affairs
avatar for Terry Katz

Terry Katz

Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional...
avatar for Melody Keel

Melody Keel

The Research Associate Group, Inc., United States
Founder, CEO and Consultant
avatar for Lindsay Kehoe

Lindsay Kehoe

Clinical Trials Transformation Initiative (CTTI), United States
Senior Project Manager, Lead Emerging Programs
avatar for Annie Kennedy

Annie Kennedy

EveryLife Foundation for Rare Diseases, United States
Chief of Policy, Advocacy, and Patient Engagement
avatar for Jo Kerwin

Jo Kerwin

Jo Ann Kerwin, United States
Senior Director Strategic Planning &. Operations
UK

Una Kessi

Oracle Health & Life Sciences, United Kingdom
Product Management Director, Safety and Pharmacovigilance
avatar for Madiha Khalid

Madiha Khalid

Larimar Therapeutics, United States
Senior Director, Medical Writing
avatar for Irfan Khan

Irfan Khan

Circuit Clinical, United States
Founder and Chief Executive Officer
WK

Warren Kibbe

National Cancer Institute, United States
Deputy Director, Data Science and Strategy
BK

Bonggi Kim

Korea Institute of Drug Safety and Risk Management, Korea, Republic of
Director
avatar for Jennifer Kim

Jennifer Kim

Tufts Center for the Study of Drug Development, United States
Research Associate Professor
avatar for Yoon Jeon (Jamey) Kim

Yoon Jeon (Jamey) Kim

Merck & Co., Inc., Rahway, NJ, USA, Panama
Director, Cluster Pharmacovigilance Lead
avatar for Ray Kirchmier

Ray Kirchmier

Deloitte, United States
Manager
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer Director, Office of Cellular and Tissue-based Products
avatar for Teppei KIUCHI

Teppei KIUCHI

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Jesper Kjaer

Jesper Kjaer

Novo Nordisk, Denmark
Global Director for Public, Private Partnerships, Strat Ops, Global...
HK

Holly Kleinschrodt

Astellas, United States
Head, Device & Operations Quality
avatar for Timothy Kline

Timothy Kline

GSK, United States
Senior Director, Global Regulatory Affairs
NK

Nobutaka Kobayashi

Mitsubishi Tanabe Pharma Corporation, Japan
Deputy Director
avatar for Toshitatsu Kobayashi

Toshitatsu Kobayashi

Otsuka Pharmaceutical Co., Ltd., Japan
Senior Regulatory Expert
MK

Marina Kobiashvili

Independent Consultant, United States
AK

Armin Koch

Hannover Medical School, Germany
Head, Institute of Biometry
avatar for Ulrike Kochendoerfer

Ulrike Kochendoerfer

Pfizer Inc, United States
Senior Director, Medical Writing
CK

Chaitanya Koduri

US Pharmacopeia, United States
Director, International Government and Regulatory Engagement
avatar for Daisuke Koga

Daisuke Koga

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of International Strategy and Planning
avatar for Isaac Kohane

Isaac Kohane

Harvard Medical School, United States
Chair, Department of Biomedical Informatics
HK

Hema Kothari

Bristol Myers Squibb, United States
Scientific Writer II
MK

Maria Koukounari

BMS, United Kingdom
Senior Director Therapeutic Area Quality
avatar for Sandra Krogulski

Sandra Krogulski

Bristol Myers Squibb, United States
Director, GRSO Innovation and Business Operations Lead
AK

Andrea Kurz

F. Hoffmann-La Roche Ltd, Switzerland
Senior Director, Lead External Advocacy Europe & Middle East
avatar for Dominique Lagrave

Dominique Lagrave

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

Melissa Laitner

National Academy of Medicine, United States
Director, Strategic Initiatives
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Tufts Center for the Study of Drug Development, United States
Director of Sponsored Research, Research Associate Professor
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Affairs – CMC
avatar for Jeff Lange

Jeff Lange

Amgen, Hong Kong
Director of Observational Research in Asia
RL

Robyn Langham

Australia Health Products Regulation Group, Australia
Chief Medical Adviser
LL

Laura Lasiter

Astrazeneca, United States
Regulatory Affairs Director- Digital Health
avatar for Marion Laumonier

Marion Laumonier

World Health Organization (WHO), Switzerland
Technical Officer, Regulatory Convergence and Networks
avatar for Agathe Le Lay

Agathe Le Lay

H. Lundbeck A/S, Denmark
Global Head of Value Evidence & Patient Insights
LL

Lauren Le

Butler University, United States
Student
avatar for Catherine Lee

Catherine Lee

Johnson and Johnson, United States
Associate Director - US Policy and Intelligence
IL

Iyn-Hyang Lee

College of Pharmacy, Yeungnam University, Korea, Republic of
Professor
avatar for Jeremiah Lee

Jeremiah Lee

University of Southern California, United States
Research Ambassador
KL

Kevin Lee

Clinvia, United States
Data Scientist
SL

Sue Lee

Takeda, United States
Director, Global Patient Safety Signal Management and Innovation
DL

Dianliang Lei

World Health Organization (WHO), Switzerland
Scientist of Technology, Standard and Norm
PL

Patty Leuchten

Diligent Pharma, United States
Founder and CEO
avatar for Bennett Levitan

Bennett Levitan

Johnson & Johnson, United States
Executive Director, Benefit-Risk Assessment / Epidemiology
YL

Ye Li

FDA, United States
Mathematical Statistician, OTS, CDER
DL

Dun Liang

Eli Lilly & Co., United States
Director, Global Regulatory Affairs, Diagnostics
ML

Marie Liles-Burden

Takeda, United States
Director, Pharmacovigilance Risk Management
avatar for Min-Jung Lim

Min-Jung Lim

MediSafe, Pharmacovigilance Services, Korea, Republic of
CEO & Senior Pharmacovigilance Consultant
avatar for Anran Liu

Anran Liu

U.S. Food and Drug Administration, United States
ORISE Postdoctoral Fellow
avatar for Hangyu (cedric) Liu

Hangyu (cedric) Liu

Biogen, United States
Associate Director, AI/ML
avatar for John Lockwood

John Lockwood

Cencora Pharmalex, United States
Sr. Director
KV

Katherine Van Loon

UCSF Helen Diller Family Comprehensive Cancer Center, United States
Director, Global Cancer Program
avatar for Kevin Lu

Kevin Lu

Taimei Technology, United States
CTO
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
avatar for Tyler Ludlow

Tyler Ludlow

Decision Skills Institute, United States
Founder and Chief Decision Scientist
NM

Nell Meosky Luo

Folia Health, United States
Chief Executive Officer
avatar for Sarah Lyons

Sarah Lyons

IQVIA, Canada
Head of Operations, Applied AI Science
avatar for Georgia Lytra

Georgia Lytra

Syneos Health , United States
Engagement Manager, R&D Advisory
avatar for Tara MacCannell

Tara MacCannell

Vertex Pharmaceuticals, United States
Global Head and Executive Director, RWE
avatar for Demetra Macheras

Demetra Macheras

AbbVie, United States
Director, Regulatory Policy and Intelligence - Regulatory Affairs
avatar for Subha Madhavan

Subha Madhavan

Pfizer Inc, United States
Vice President and Head of AI/ML, Global Biometrics and Data...
avatar for Nicole Mahoney

Nicole Mahoney

Novartis Pharmaceuticals Corporation, United States
Executive Director US Regulatory Policy & Intelligence
MM

Madhurima Majumder

Bayer US LLC, United States
Associate Director, Clinical Statistics and Analytics
TM

Tariro Makadzange

Zimbabwe Clinical Research Center, United States
Executive Director, Founder
RM

Ritika Malik

Temple University, United States
Student
avatar for Alison Maloney

Alison Maloney

Bayer , United States
Head of Regulatory Affairs North America
avatar for Shweta Maniar

Shweta Maniar

Google Cloud, United States
Director, Healthcare and Life Sciences Solutions
avatar for Kwaku Marfo

Kwaku Marfo

IQVIA, Ghana
Africa Market Development Specialist
JM

Joseph Markmann

United States
Principal Data Science Lead, Global Regulatory Affairs
KM

Kristi Martin

Camber Collective, United States
Director
avatar for Sarah Martin

Sarah Martin

Eli Lilly & Co., United States
Senior Director - Global Regulatory Policy (Oncology)
avatar for Christine Mayer-Nicolai

Christine Mayer-Nicolai

Merck Healthcare KGaA, Germany
Vice President, Regulatory and Scientific Policy
avatar for Christy Mazzarisi

Christy Mazzarisi

Network Partners Group, United States
Quality and Clinical COE Lead
avatar for Jennifer McCafferty

Jennifer McCafferty

Merck, United States
Senior Vice President, Regulatory CMC and Quality Assurance
avatar for Neil McCullough

Neil McCullough

IQVIA, United States
Executive Vice President, Clinical Quality and Compliance
avatar for Allison McDougall

Allison McDougall

G3, United States
Executive Vice President
avatar for Niamh McGuinness

Niamh McGuinness

IQVIA, United States
Director of Pharma Solutions, Applied AI Science Team
avatar for Kelly McKee

Kelly McKee

Evinova, An Astrazeneca Company, United States
Head of Innovative Patient Recruitment
avatar for Mark McKenzie

Mark McKenzie

EmVenio Research, United States
Chief Medical Officer
AM

Amanda McMannis

The Prostate Cancer Clinical Trials Consortium, United States
Associate Director, Clinical Operations
avatar for Lindsay McNair

Lindsay McNair

Equipoise Consulting, United States
Principal Consultant
avatar for Melodi McNeil

Melodi McNeil

AbbVie, United States
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early...
avatar for Carly McWilliams, MBA

Carly McWilliams, MBA

Roche Diagnostics, United States
Head of Regulatory Policy
CM

Christine Mears

Generate BioMedicines, United States
Executive Director, Portfolio Management
avatar for David Meats

David Meats

Certara, United States
Director, Regulatory Services & Medical Affairs Management
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and...
avatar for Doug Melton

Doug Melton

Vertex, United States
Distinguished Research Fellow
avatar for Angela Men

Angela Men

The Whiteoak Group, Inc, United States
Chief Executive Officer
avatar for Amber Meriwether

Amber Meriwether

Astellas Pharma, United States
Corporate Strategy
avatar for Danielle Metzger

Danielle Metzger

PharmaQ Consulting, United States
Principal Quality Consultant
AM

Anton Mihic

McKinsey & Company, United States
Partner
avatar for Alexis Miller

Alexis Miller

Merck & Co., Inc., United States
Acting Global Lead, Global Regulatory Policy and Intelligence
BM

Bruce Miller

COPD Foundation, United States
Chief Scientific Officer
avatar for Yuki Miyatake

Yuki Miyatake

Eli Lilly Japan, Japan
Sr Manager
DM

David Moeny

FDA, United States
Acting Deputy Director, Office of Pharmacovigilance and Epidemiology,...
KM

Korrey Monroe

North Carolina Community Health Center Association, United States
Program Manager
avatar for Carol Morales

Carol Morales

Astellas, United States
Lead, Quality Management and Capabilities
GM

Greg Morehouse

Abbvie, United States
Senior Manager, RA Device, Combination Products
MM

Marcelo Moreira

ANVISA, Brazil
GENERAL MANAGER
avatar for Toru Morishita

Toru Morishita

GlaxoSmithKline, United States
Manager, Global Regulatory Affairs
BM

Ben Moscovitch

Amazon Web Services, United States
Public Policy
TM

Taraneh Mousavi

University of Maryland, Baltimore, United States
PhD Student
FM

Florence Mowlem

Umotif, United Kingdom
Chief Scientific Officer
avatar for Katie Moy

Katie Moy

Acadia Pharmaceuticals, United States
Associate Director, Medical Information & Review
avatar for Willie Muehlhausen

Willie Muehlhausen

SAFIRA Clinical Research, Ireland
Co-Founder
avatar for David Mukanga

David Mukanga

Bill & Melinda Gates Foundation, United States
Deputy Director, Africa Regulatory Systems
avatar for Saurabh Mukhopadhyay

Saurabh Mukhopadhyay

Abbvie, United States
Research Fellow, Statistical Innovations
avatar for Theresa Mullin

Theresa Mullin

FDA, United States
Associate Center Director - Strategic Initiatives, CDER
avatar for Erin Mulrooney

Erin Mulrooney

Daiichi Sankyo, Inc, United States
Director, Portfolio Management
GM

Greeshma Mundayat

Maxisit, United States
Solution Owner
avatar for Ryan Murphy

Ryan Murphy

ICON, United States
Associate Outcomes Researcher
KM

Kiran Musunuru

University of Pennsylvania, United States
Professor of Medicine
avatar for Nancy Myers

Nancy Myers

Catalyst Healthcare Consulting, United States
CEO and Founder
avatar for Jane Myles

Jane Myles

Decentralized Trials and Research Alliance, United States
Program Director
avatar for Sridevi Nagarajan

Sridevi Nagarajan

Independent, United Kingdom
DIA Communities Lead for AI in Healthcare
avatar for Meera Nagaria

Meera Nagaria

Johnson & Johnson, United States
Senior Data Scientist
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Medidata Solutions, United States
Senior Director
avatar for Kenichi Nakamura

Kenichi Nakamura

National Cancer Center Hospital, Japan
Director, Department of International Clinical Development
SN

Sumati Nambiar

Johnson and Johnson, United States
Senior Director
avatar for Rohit Nambisan

Rohit Nambisan

Lokavant, United States
CEO & Co-Founder
SN

SRIVIDYA NARAYANAN

Northeastern University, United States
Student
avatar for Wassim Nashabeh

Wassim Nashabeh

Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Technical Regulatory Policy &...
avatar for Aliza Nathoo

Aliza Nathoo

F. Hoffmann-La Roche Ltd., Canada
Senior Director, Content Strategy
NN

Nancy Ngum

AUDA-NEPAD, South Africa
Public Health Officer
avatar for Christiane Niederlaender

Christiane Niederlaender

Parexel International, United Kingdom
Vice President, Technical
avatar for Shinichi Noda

Shinichi Noda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division Director, Division of Planning and Management, Office of...
avatar for Perla Nunes

Perla Nunes

Community Outreach and Clinical Research DEI Thought Leader, United States
Patient Advocate
JN

Jude Nwokike

USP, United States
Vice President and Director, PQM+
BO

Brendan O'Leary

United States
Consultant
SO

Sean Ogle

SEI Inc., United States
Senior Consultant
MO

Miyako Okayama

Otsuka Pharmaceutical, Co., Ltd., Japan
Regulatory Expert, Regulatory Technology & Operations Office,...
EO

Evon Okidi

Medidata Solutions, A Dassault Systemes Company, United States
Senior Data Scientist
avatar for Ebere Okpara

Ebere Okpara

University of Illinois Chicago, United States
Research Assitant
avatar for Jimi Olaghere

Jimi Olaghere

United States
Patient Advocate
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

ANVISA, Brazil
Health Regulation Expert
RO

Rosemary Orciari

Pfizer, United States
Senior Directory, Reg Intel, Policy and QMS Lead
avatar for Feisal Othman

Feisal Othman

Bristol Myers Squibb, United States
Benefit Risk Assessment Lead
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