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avatar for Emily Gebbia

Emily Gebbia

FDA, United States
Associate Director for Regulatory Development, OSI, OC, CDER
avatar for Patrick Gee

Patrick Gee

iAdvocate, United States
Chief Executive Hope Dealer & Founder
avatar for Victoria Gemme

Victoria Gemme

National Organization for Rare Disorders, United States
Director, Policy and Regulatory Affairs
avatar for Lincy George

Lincy George

Sanofi, United States
Vice President, Oncology Global Regulatory Affairs
avatar for Ellyn Getz

Ellyn Getz

CSL Behring, United States
Director, R&D Partnerships
avatar for Kenneth Getz

Kenneth Getz

Tufts University School of Medicine, United States
Tufts Center for the Study of Drug Development
avatar for Alicia Gilsenan

Alicia Gilsenan

RTI Health Solutions, United States
Vice President, Epidemiology
avatar for Richard Gliklich

Richard Gliklich

OM1, United States
Founder & Chief Executive Officer
avatar for Sarah Golding

Sarah Golding

Therapeutics Goods Administration, Australia
Senior Medical Officer - Oncology and Malignant Haematology Clinical...
avatar for Katharina Goldner

Katharina Goldner

Bayer AG, Germany
Regional Regulatory Affairs Manager
avatar for Gretchen Goller

Gretchen Goller

Pfizer, United States
Head, Recruitment and Retention
avatar for Julien Nunes Goncalves

Julien Nunes Goncalves

Cyntegrity, South Africa
Head of Growth
MP

Mercedes Perez Gonzalez

WHO, Switzerland
Technical officer
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Johnson & Johnosn Innovative Medicines, United States
Director, Biostatistics
RG

Ryan Gough

Woodberry Associates and PACH, United States
Partner, Senior Vice President, Public Affairs
avatar for Heidi Grabenstatter

Heidi Grabenstatter

Critical Path Institute, United States
Scientific Director, RDCA-DAP
avatar for Cheryl Grandinetti

Cheryl Grandinetti

FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
avatar for Courtney Granville

Courtney Granville

GO2 For Lung Cancer, United States
Chief Scientific Officer
avatar for Hannah Graunke

Hannah Graunke

Duke-Margolis Institute For Health Policy, United States
Senior Policy Analyst
avatar for Dionna Green

Dionna Green

FDA, United States
Director, Office of Pediatric Therapeutics
avatar for Catherine Gregor

Catherine Gregor

Florence Healthcare, United States
Chief Clinical Trial Officer
avatar for Susan Gregurick

Susan Gregurick

National Institute of Health, United States
Associate Director, Data Science and Director, NIH ODSS
avatar for Vinita Grover

Vinita Grover

Microsoft, United States
avatar for Anthony Gulotta

Anthony Gulotta

Leal Health, United States
Head of Sales and Strategic Partnerships
avatar for Tanvi Gupte

Tanvi Gupte

University of Maryland, United States
Student
avatar for Michelle Gyzen

Michelle Gyzen

IQVIA, United States
Senior Director, Regulatory Innovation & Technology
avatar for Ann Marie Hake

Ann Marie Hake

Eli Lilly and Company, United States
Executive Director, Medical – Digital Health
avatar for Hilmar Hamann

Hilmar Hamann

European Medicines Agency, Netherlands
Head of Information Management
avatar for Tarek Hammad

Tarek Hammad

Takeda, United States
Vice President, Head of Medical Safety, Marketed Products &...
avatar for Gerrit Hamre

Gerrit Hamre

Duke-Margolis Institute For Health Policy (DMI), United States
Research Director
avatar for Jackson Hanf

Jackson Hanf

University of Southern California, United States
Student
avatar for Morgan Hanger

Morgan Hanger

Clinical Trials Transformation Initiative (CTTI), United States
Executive Director
avatar for Magdalena Harrington

Magdalena Harrington

Pfizer, United States
Senior Director, Patient-Centered Outcomes Assessment (PCOA) Team Lead
avatar for Meghann Hartnett

Meghann Hartnett

DIA, United States
Associate Director, Global Products
avatar for Fadhilah Hasbullah

Fadhilah Hasbullah

National Pharmaceutical Regulatory Agency (NPRA) Malaysia, Malaysia
GCP Inspector
avatar for Sema Hashemi

Sema Hashemi

FDA, United States
Senior International Policy Advisor
avatar for Lani Hashimoto

Lani Hashimoto

Hashimoto Consulting Services, United States
Consultant, Patient Experience
avatar for Kristin Hatcher

Kristin Hatcher

Global Liver Institute/Alpha One Patient, United States
Director of Pediatric and Rare Disease/ Alpha One Lived Experience...
avatar for Brett Hauber

Brett Hauber

Pfizer Inc, United States
Patient Preference Evidence Integration Lead
RH

Reina Hayashi

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
avatar for Melissa Heidelberg

Melissa Heidelberg

Takeda, United States
Director, Global Bioethics and Technology Ethics Lead
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Research Director, Real-World Evidence
avatar for Nicole Herk

Nicole Herk

Medtronic, United States
Analytics Director
MP

Melissa Pauline Herman

Lundbeck A/S, Denmark
Senior Specialist, Patient Insights
avatar for Adrian Hernandez

Adrian Hernandez

Duke Clinical Research Institute , United States
Professor of Medicine; Executive Director
avatar for Ralf Herold

Ralf Herold

European Medicines Agency, Netherlands
Head of Regulatory Science and Academia Workstream
avatar for Christopher Herrick

Christopher Herrick

Mass General Brigham (MGB), United States
VP of Research Systems and Technology
LH

Leanne Hickman

Eli Lilly and Company, United States
Senior Vice President, Global Quality Analytical Sciences & QC...
avatar for Amber Hill

Amber Hill

R.grid, United Kingdom
Founder & CEO
avatar for Amber Hill

Amber Hill

R.grid, United Kingdom
Founder & CEO
avatar for Hideki Hiraoka

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 Kowid Ho

Kowid Ho

F. Hoffmann-La Roche Ltd, Switzerland
Pharma Technical Regulatory Policy
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, MBA USP/Esalq, Brazil
Pharmacovigilance Specialist
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 Brett Howard

Brett Howard

USP, United States
Senior Director, US Regulatory Policy
avatar for Endang Hoyaranda

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, United States
VP, Biostatistics
avatar for Li Huang

Li Huang

Phastar, United States
Principal Biostatistician
avatar for Sheilyn Huang

Sheilyn Huang

FDA, United States
Consumer Safety Officer, Pharmacovigilance Compliance Team
avatar for Tse-Yin Huang

Tse-Yin Huang

Center for Drug Evaluation, Taiwan, Taiwan
Reviewer
avatar for Wei-I Huang

Wei-I Huang

Taiwan Drug Relief Foundation, Taiwan
Director, Division of Drug Safety
avatar for Lisa Hubbard

Lisa Hubbard

Opus Regulatory, Inc., United States
Principal Consultant, Regulatory Advertising and Promotion
avatar for Melissa Hunt

Melissa Hunt

Health Canada, Canada
Director
BH

Brian Hunter

CNS Healthcare / Sitecentric, United States
VP / Chief Operating Officer
BH

Brian Hunter

SiteCentric, United States
Chief Operating Officer
avatar for Robert Huntington

Robert Huntington

ROTHWELL, FIGG, ERNST & MANBECK, P.C. , United States
Lawyer
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Parexel, United States
Chief Patient Officer
avatar for Campbell Hutton

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
avatar for Anna Hyde

Anna Hyde

Arthritis Foundation, United States
Vice President of Advocacy & Access
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
avatar for Taruna Ikrar

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
avatar for Elizabeth Iorns

Elizabeth Iorns

CEO and Co-Founder, United States
Science Exchange
MI

Maxwell Isaacoff

Elevance Health, Inc, United States
Director, Federal & External Affairs
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of PMDA, Washington D.C. Office
avatar for Md Rashedul Islam

Md Rashedul Islam

Queensborough Community College, United States
Student, Undergraduate Research Scholar
avatar for David Isom

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
Senior Corporate Counsel
CJ

Charles Jaffe

HL7, United States
Chief Executive Officer
avatar for Nabeela Jahangeer

Nabeela Jahangeer

University of Southern California, United States
Student
RJ

Ritesh Jain

EMD Serono, United States
Senior Director
avatar for Sid Jain

Sid Jain

Recursion, United States
Senior Vice President, Clinical Development and Data Science
avatar for Linda Jeng

Linda Jeng

FDA, United States
Associate Director for Biomedical Informatics
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

LifeSciHub , United States
Drug Development Multi-Functionalist
avatar for Xiangxiang Jiang

Xiangxiang Jiang

University of South Carolina, United States
PhD student
avatar for Tony Johnson

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

Kenneth Wiley. Jr.

National Center For Advancing Translational Sciences, United States
Section Chief
avatar for Tom Julian

Tom Julian

Gilead Sciences, United States
Assoc. Director Design and Innovation
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Pfizer Inc, United States
Clinical Lead
avatar for Patricia Jumelle

Patricia Jumelle

University of Southern California, United States
Student
avatar for HYUN JOO JUNG

HYUN JOO JUNG

Korea Institute of Drug Safety & Risk Management, Korea, Republic of
Departiment of Drug Safty Information
avatar for Tae Hyun Jung

Tae Hyun Jung

FDA, United States
Senior Statistical Reviewer, CDER
EJ

Elizabeth Jungman

United States
Former FDA Chief of Staff
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 Lisa Kammerman

Lisa Kammerman

Kammerman Consulting, LLC, United States
Regulatory Statistics and PRO Consultant
avatar for Joseph Kannarkat

Joseph Kannarkat

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

Chris Karlovich

Frederick National Laboratory for Cancer Research, United States
Director, Molecular Characterization Laboratory
avatar for Stephen Karpen

Stephen Karpen

Breakthrough T1D, United States
Senior Director, Regulatory Affairs
avatar for Elaine Katrivanos

Elaine Katrivanos

Tempus AI, United States
Vice President 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
avatar for Una Kessi

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
avatar for Warren Kibbe

Warren Kibbe

National Cancer Institute, United States
Deputy Director, Data Science and Strategy
avatar for Emma Kikerkov

Emma Kikerkov

Eshelman School of Pharmacy, United States
Pharmacy and MPH Student
avatar for Bonggi Kim

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 Sabina Kineen

Sabina Kineen

Rare Disease Patient Advocacy, United States
Lived Experience Expert
avatar for Ray Kirchmier

Ray Kirchmier

Deloitte, United States
Manager
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

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

Teppei KIUCHI

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

Jesper Kjaer

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

Matthew Klein

PTC Theraputics, United States
CEO
avatar for Holly Kleinschrodt

Holly Kleinschrodt

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

Timothy Kline

GSK, United States
Senior Director, Global Regulatory Affairs
avatar for Nobutaka Kobayashi

Nobutaka Kobayashi

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

Toshitatsu Kobayashi

Otsuka Pharmaceutical Co., Ltd., Japan
Senior Regulatory Expert
avatar for Marina Kobiashvili

Marina Kobiashvili

Independent Consultant, United States
AK

Armin Koch

Hannover Medical School, Germany
Head, Institute of Biometry
avatar for Chaitanya Koduri

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
avatar for Daisuke Koide

Daisuke Koide

Graduate School of Medicine, The University of Tokyo, Japan
Project Professor, Department of Biostatistics and Bioinformatics
avatar for Evdokia Korakianiti

Evdokia Korakianiti

European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
avatar for Hema Kothari

Hema Kothari

Bristol Myers Squibb, United States
Scientific Writer II
avatar for Namita Kothary

Namita Kothary

FDA, United States
Associate Director, DEPS, OSI, OC, CDER
avatar for Sandra Krogulski

Sandra Krogulski

Bristol Myers Squibb, United States
Director, GRSO Innovation and Business Operations Lead
avatar for Andrea Kurz

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
avatar for Melissa Laitner

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
avatar for Robyn Langham

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 Tony Lawler

Tony Lawler

Australian Department of Health and Aged Care, Australia
Deputy Secretary, Health Products Regulation Group
avatar for Agathe Le Lay

Agathe Le Lay

H. Lundbeck A/S, Denmark
Global Head of Value Evidence & Patient Insights
avatar for Lauren Le

Lauren Le

Butler University, United States
Student
avatar for Charles Lee

Charles Lee

AstraZeneca, United States
Executive Regulatory Science Director
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
avatar for Kerry Jo Lee

Kerry Jo Lee

FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare...
avatar for Kevin Lee

Kevin Lee

Clinvia, United States
Data Scientist
avatar for Sue Lee

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
avatar for Patty Leuchten

Patty Leuchten

Diligent Pharma, United States
Founder and CEO
PL

Patrick Leung

Faro Health Inc. , United States
Chief Technology Officer
avatar for Bennett Levitan

Bennett Levitan

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

Jie Li

FDA, United States
Associate Director for RWE, OSE, CDER
avatar for Ye Li

Ye Li

FDA, United States
Mathematical Statistician, OTS, CDER
avatar for Dun Liang

Dun Liang

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

Franca Ligas

European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
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
PL

Patrick Loerch

Gilead Sciences, Inc., United States
Senior Vice President, Clinical Data Science
avatar for Katherine Van Loon

Katherine Van Loon

UCSF Helen Diller Family Comprehensive Cancer Center, United States
Director, Global Cancer Program
avatar for James Lovett

James Lovett

Myonex, United States
CEO
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
BM

Bei Ma

The Pinea Group, LLC, United States
Founder and CEO
BM

Bo Maach-Møller

Novo Nordisk A/S, Denmark
Vice President, Risk Based Quality Management
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 Christina Mack

Christina Mack

IQVIA, United States
Chief Scientific Officer, Real-World Solutions
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, United States
Executive Director US Regulatory Policy & Intelligence
avatar for Stephen Mahoney

Stephen Mahoney

Gilead Sciences, United States
Head of Quality Policy and Advocacy
avatar for Madhurima Majumder

Madhurima Majumder

Bayer US LLC, United States
Associate Director, Clinical Statistics and Analytics
avatar for Tariro Makadzange

Tariro Makadzange

Zimbabwe Clinical Research Center, United States
Executive Director, Founder
avatar for Martin Makary

Martin Makary

FDA, United States
Commissioner
avatar for Ritika Malik

Ritika Malik

Temple University, United States
Student
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