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avatar for Martine Dehlinger-Kremer

Martine Dehlinger-Kremer

ICON Plc, Germany
Vice President Scientific Affairs, Pediatric Subject Matter Expert
PD

Paulla Dennis

Fortrea, United States
Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics
avatar for Mehul Desai

Mehul Desai

FDA, United States
Medical Reviewer, ORDPURM/DRDMG, OND, CDER
LD

Laura DiAngelo

AgencyIQ by POLITICO, United States
Research Director
avatar for Victoria DiBiaso

Victoria DiBiaso

Sanofi, France
Global Head, Patient Informed Development and Health Value Translation
avatar for John Dobbins

John Dobbins

Transcelerate Biopharma Inc., United States
Program Manager, Portfolio Change Management
RD

Rama Doddi

Northeastern University, United States
MS Regulatory Affairs Student
avatar for Victoria Dohnal

Victoria Dohnal

Johnson & Johnson Innovative Medicine, United States
Director, Global Regulatory Policy and Intelligence
avatar for Brian Dolan

Brian Dolan

Fortrea, United States
Vice President Artificial Intelligence and Machine Learning
avatar for Tiffany Dominic

Tiffany Dominic

Pfizer, United States
Risk Management Fellow
KD

Katherine Donigan

Sarepta, United States
Senior Director, Science and Regulatory Policy
SD

Sahith Doppalapudi

Bristol-Myers Squibb Company, United States
Sr. Manager, PV Analytics Center of Excellence
AD

Andrea Doyle

Sanofi, United States
Head, Global Regulatory Affairs, Neurology
avatar for Christopher Doyle

Christopher Doyle

WCG, United States
Senior Director, IBC Services
avatar for Megan Doyle

Megan Doyle

Eli Lilly & Company, United States
Associate Vice President, Assistant General Counsel - Diagnostics
avatar for Charlie Dragovich

Charlie Dragovich

California Academy of Managed Care Pharmacy, United States
Board of Directors
avatar for Nancy Dreyer

Nancy Dreyer

Dreyer Strategies LLC, United States
Founder
MD

Mario DuCre

Patient, United States
avatar for James Duhig

James Duhig

AbbVie, United States
Global Head, Office of Health Literacy
avatar for Matt D'Ambrosio

Matt D'Ambrosio

Duke-Margolis Institute For Health Policy, United States
Policy Analyst
ME

Monica Eason

Genentech, A Member of the Roche Group, United States
Clinical Operations Portfolio Leader
avatar for Danielle Friend Economo

Danielle Friend Economo

Johnson & Johnson Innovative Medicine, United States
Senior Director, US Head Regulatory Policy and Intelligence
avatar for Vera Ehrenstein

Vera Ehrenstein

Aarhus University, Denmark
Professor, Department of Clinical Medicine, Dept of Clinical...
ME

Mica Elizalde

Merck & Co., Inc., United States
Principal Scientist, Regulatory Digital Health
avatar for Tamei Elliott

Tamei Elliott

DIA, United States
Associate Director, Scientific Programs
avatar for M. Khair ElZarrad

M. Khair ElZarrad

FDA, United States
Director, Office of Medical Policy, CDER
avatar for Jennifer Emerson

Jennifer Emerson

Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
avatar for Andrew Emmett

Andrew Emmett

Pfizer Inc, United States
FDA Liaison | US Regulatory Policy and Global Intelligence
NE

Nora Emmott

Duke Margolis Institute For Health Policy, United States
Senior Policy Analyst
PE

Pierre Engel

Centogene Gmbh, Germany
Senior Director Business Development
avatar for Emily Epstein

Emily Epstein

Weill Cornell Medicine, United States
Clinical Behavioral Health Specialist
avatar for Gul Erdemli

Gul Erdemli

Novartis Pharmaceuticals Corporation, United States
Global Program Regulatory Director
avatar for Thierry Escudier

Thierry Escudier

DCRIPT, France
Chairman, Strategic Consulting
avatar for Sheila M Estela

Sheila M Estela

Novartis Pharmaceuticals Corporation, United States
Regional Patient Safety Head US and Canada
ME

Mario Estevez

Patient Caregiver and Racial Equity Institute, United States
Organizer
JE

Jennifer Evans

Health Canada, Canada
Compliance and Enforcement Specialist
SE

Samuel Ewusie

Bristol-Myers Squibb Company, United States
Associate Director, Safety Evidence and Science
avatar for Tala Fakhouri

Tala Fakhouri

FDA, United States
Associate Director for Policy Analysis, Office of Medical Policy, CDER
avatar for Marwan Fathallah

Marwan Fathallah

DIA, United States
President & Chief Executive Officer
OF

Oliver Fink

Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
Head Learning, Processes and Digitalization
AF

Adam Fisher

FDA, United States
Director, Enterprise Project Staff, OQA, OPQ, CDER
AF

Adriane Fisher

FDA, United States
Regulatory Project Manager, OTP, CBER
CF

Charles Fisher

Unlearn.AI, United States
Founder and Chief Executive Officer
avatar for Ron Fitzmartin

Ron Fitzmartin

FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
avatar for Malin Fladvad

Malin Fladvad

Uppsala Monitoring Centre, Sweden
Portfolio Officer
JF

Jeanine Flanigan

Sandoz, United States
HEOR specialist
avatar for Maria Florez

Maria Florez

Tufts Center For the Study of Drug Development, Tufts Univers, United States
Senior Consultant
avatar for Ruby Ford

Ruby Ford

Tufts School of Medicine, United States
Research Analyst
avatar for Darcy Frear

Darcy Frear

Bridgebio, United States
Associate Director
MF

Michael Fries

CSL Behring, United States
Head, Biostatistics
avatar for Pete Fronte

Pete Fronte

Altura, United States
President and Chief Executive Officer
avatar for David Fryrear

David Fryrear

Astellas, United States
Executive Vice President and Head of Quality Assurance
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
avatar for Davera Gabriel

Davera Gabriel

Evidentli USA LLC, United States
Director of Client Success
avatar for Alexander Gaffney

Alexander Gaffney

AgencyIQ by POLITICO, United States
Executive Director, Regulatory Policy And Intelligence
avatar for Karim Galil

Karim Galil

Mendel.ai, United States
CEO and Co-founder
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
avatar for Kayla Garvin

Kayla Garvin

FDA, United States
Sr Regulatory Health Project Manager
avatar for Emily Gebbia

Emily Gebbia

FDA, United States
Associate Director for Regulatory Development, OSI, OC, CDER
WG

Wes Gerbig

Eli Lilly and Company, United States
Director, Global Regulatory Affairs, Drug Delivery and Digital Health
avatar for Kenneth Getz

Kenneth Getz

Center For the Study of Drug Development, United States
Tufts Center for the Study of Drug Development
KG

Katy Ghantous

Medidata Solutions, United States
Senior Director, Data Science
NG

Neda Gharavi

BioPharma Services, Canada
Senior Director Medical Writing & Regulatory Affairs
MA

Majdi Al Gharsan

Ministry of Defence, Saudi Arabia
Director, Director of Medical Services
TG

Tapash Ghosh

FDA, United States
TL
avatar for Kathleen Giacomini

Kathleen Giacomini

University of California San Francisco, United States
Dean, School of Pharmacy, Professor and Principal Investigator
avatar for Madhavi Gidh-Jain

Madhavi Gidh-Jain

Sanofi, United States
Global Medical Writing and Document Management Head
avatar for Alicia Gilsenan

Alicia Gilsenan

RTI Health Solutions, United States
Vice President, Epidemiology
avatar for Sabrina Girty

Sabrina Girty

Merck & Co., Inc., United States
Executive Director, Global Regulatory Affairs, Oncology
avatar for Richard Gliklich

Richard Gliklich

OM1, United States
Chief Executive Officer
JG

Jamie Goldfarb

Trialbee, United States
Director, Patient Recruitment Strategy
avatar for Cammilla Horta Gomes

Cammilla Horta Gomes

Roche, Brazil
LATAM Regulatory Policy Lead
CG

Cecile Gonzalez-Cerimele

Eli Lilly and Company, United States
Executive Director Diversity and Inclusion in Clinical Trials
RG

Rosa Gonzalez-Quevedo

European Medicines Agency, Netherlands
Scientific Research Officer
avatar for Cheryl Grandinetti

Cheryl Grandinetti

FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
avatar for Andrea Gray

Andrea Gray

FDA , United States
Biomedical Engineer Advisor, CBER
avatar for Andrew Gray

Andrew Gray

Johnson & Johnson, United Kingdom
Director, QA Clinical Therapeutic Area Head
avatar for Erin Greene

Erin Greene

Takeda, United States
US Lead, Global Regulatory Policy and Innovation
avatar for Renmeet Grewal

Renmeet Grewal

FDA, United States
Division Director, Office of Regulatory Operations (DRO-II), OND, CDER
PG

Productlife Group

Productlife Group, France
avatar for Michael Gyulay

Michael Gyulay

EMD Serono, United States
Director, Medical Writing, Oncology and I-Oncology
avatar for Mary Thanh Hai

Mary Thanh Hai

FDA, United States
Deputy Director for Clinical, OND, CDER
avatar for Sushma D.A. Hallock

Sushma D.A. Hallock

Biogen, United States
Project Management and Operations
avatar for Hilmar Hamann

Hilmar Hamann

European Medicines Agency, Netherlands
Head of Information Management
MA

Muhammad Ali Hameed

Population Health Research Institute, Canada
Chief Operating Officer
avatar for William Hammond

William Hammond

Duke University, United States
Professor of Biostatistics and Bioinformatics
avatar for Kristen Harnack

Kristen Harnack

Castor, United States
Director of Solutions Consulting
HH

Helen Hartman

Pfizer Inc, United States
Director, Global Regulatory Sciences
avatar for Lani Hashimoto

Lani Hashimoto

Novartis Pharmaceuticals Corporation, United States
Associate Director, Patient Engagement
avatar for Sabine Haubenreisser

Sabine Haubenreisser

European Medicines Agency, Netherlands
Principal Scientific Administrator, Stakeholders and Communication...
BH

Brett Hauber

Pfizer Inc, United States
Senior Director, Patient Preference Elicitation
avatar for Paul Hayashi

Paul Hayashi

FDA, United States
Physician Lead, DILI Team, Division of Hepatology and Nutrition, OND,...
avatar for Datacubed Health

Datacubed Health

United States
avatar for Flatiron Health

Flatiron Health

United States
avatar for Syneos Health

Syneos Health

United States
avatar for Mo Heidaran

Mo Heidaran

Cellx Inc., Consulting, United States
Chief Regulatory Scientist
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Duke-Robert J. Margolis, MD, Center for Health Policy, United States
Research Director, Real-World Evidence
avatar for Nick Henscheid

Nick Henscheid

Critical Path Institute, United States
Senior Scientist
CH

Cheryl Hergert

University of Southern California, United States
avatar for Loriana Hernandez-Aldama

Loriana Hernandez-Aldama

Armorup For Life, United States
Patient Advocate|2x Survivor| Founder, ArmorUp for Life
avatar for Jan Hewett

Jan Hewett

FDA, United States
Regulatory Counsel for Policy, OSI, CDER
avatar for Karen Hicks

Karen Hicks

FDA, United States
Deputy Director, Office of Medical Policy, CDER
avatar for Katherine High

Katherine High

Rockefeller University, United States
Co-Founder and Former President, Sparks Therapeutics; Visiting...
avatar for Brad Hightower

Brad Hightower

Hightower Clinical, United States
Chief Executive Officer
JH

Jenny Higley

Biogen, United States
Director, Head of Feasibility CoE
JH

Joanne Hilton

GlaxoSmithKline, United Kingdom
Executive Director, Medical Writing
avatar for Martin Hodosi

Martin Hodosi

Kearney, United Kingdom
Partner, Healthcare and Life Sciences Practices
avatar for Marcel Hoefnagel

Marcel Hoefnagel

Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
KH

Karin Hoelzer

NORD, United States
Senior Director, Policy and Regulatory Affairs
HH

Henry Hoffman

BASE Life Sciences - an Infosys company, Switzerland
Senior Vice President, R&D
avatar for Kyle Hogan

Kyle Hogan

Datacubed Health, United States
President
avatar for Sonja Hokett

Sonja Hokett

BioXcel Therapeutics, United States
Executive Director, Medical Managed Care & HEOR
SH

Stacy Holdsworth

Eli Lilly and Company, United States
Associate Vice President, US Regulatory Policy & Strategy
avatar for Brett Howard

Brett Howard

USP, United States
Senior Director, US Regulatory Policy
avatar for John Van Hoy

John Van Hoy

PPD, part of Thermo Fisher Scientific, United States
Executive Director, Data Science & Advanced Analytics
avatar for Erya Huang

Erya Huang

Bayer AG, United States
Associate Director Statistics
avatar for Li Huang

Li Huang

Phastar, United States
Principal Biostatistician
avatar for Lloryn Hubbard

Lloryn Hubbard

PPD Part of Thermo Fisher Scientific, United States
Head of Patient Diversity
LH

Lindsay Hughes

IQVIA, United States
Principal, Patient Experience Solutions and Patient Centered Solutions
avatar for Valerie Huh

Valerie Huh

Propharma Group, United States
Associate Director, Global Innovation and Implementation
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Parexel , United States
Chief Patient Officer
avatar for Virginia Hussong

Virginia Hussong

FDA, United States
Branch Chief, Data Standards, CBER
avatar for Stuart Ince

Stuart Ince

Accent Therapeutics, Inc, United States
Vice President, Program Leadership
avatar for Milliman IntelliScript

Milliman IntelliScript

United States
AI

Alexei Ionan

FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics
avatar for Toshiko Ishibashi

Toshiko Ishibashi

Daiichi Sankyo Co., Ltd., Japan
Oncology Medical Science Department, Medical Affairs Division
avatar for Hisahiro Ito

Hisahiro Ito

National Cancer Center Japan, Japan
Head of Project Management Office
RI

Rajashekhar Ittedi

Northeastern University, United States
Student
avatar for Karthik Iyer

Karthik Iyer

Merck & Co., Inc., United States
Director, Global Quality
avatar for Britta Jacobsen

Britta Jacobsen

Whitsell Innovations, Inc. , United States
Medical Writer and Consultant
RJ

Rebecca James

KPMG, LLC, United States
Director - Advisory
avatar for Ellen Janssen

Ellen Janssen

Janssen Research & Development LLC, United States
Director, Global Epidemiology, Benefit-Risk Assessment
avatar for Gene Jay

Gene Jay

Evernorth Health Services, United States
Head of Sales and Account Management
avatar for Veronika Jekerle

Veronika Jekerle

European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
avatar for Rekha Jhamnani

Rekha Jhamnani

FDA, United States
Medical Officer, DNPDI, OND, CDER
avatar for Zarnab Jillani

Zarnab Jillani

FDA, United States
Medication Error Pharmacovigilance and Risk Management Fellow
avatar for Juan Jiménez

Juan Jiménez

Appian, United States
Lead Software Engineer, Product Strategy
avatar for Emily (Xianghong) Jing

Emily (Xianghong) Jing

FDA, United States
Associate Director for Scientific Coordination, OBP, OPQ, CDER
BJ

Brian Johnson

Takeda, United States
Vice President, R&D Technology
avatar for Erik Johs

Erik Johs

Medidata Solutions, United States
Vice President, Platform Engineering
avatar for Jeremy Jokinen

Jeremy Jokinen

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

Gaurav Josan

Clario, United States
Senior Vice President, R&D
avatar for Aaron Josephson

Aaron Josephson

Teva Pharmaceuticals, United States
Senior Director, Global Regulatory Policy
avatar for Waheed Jowiya

Waheed Jowiya

Novo Nordisk A/S, Denmark
Digitalisation Strategy Lead
SH

Sung Hoon Jung

The Catholic University of Korea, Korea, Republic of
Professor
avatar for Candice Junge

Candice Junge

Ionis Pharmaceuticals, Inc., United States
Executive Director, Neurology Program and Clinical Lead
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 Aaron Kamauu

Aaron Kamauu

Navidence LLC, United States
CEO
avatar for Dean Kamen

Dean Kamen

DEKA Research & Development Corp., United States
Founder
avatar for Regina Mariam Kamoga

Regina Mariam Kamoga

Community Health And Information Network ( CHAIN), Uganda
Executive Director
avatar for Sarah Kang

Sarah Kang

FDA, United States
Safety Evaluator
avatar for Tse Siang Kang

Tse Siang Kang

Pfizer Pte Ltd, Singapore
Head of Regulatory Affairs, North, East, West Asia, Global Regulatory
avatar for Mamiko Kasho

Mamiko Kasho

Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs
avatar for David Kaslow

David Kaslow

FDA, United States
Director, Vaccines Research and Review (OVRR), CBER
BK

Bryan Katz

Propharma Group, United States
Chief Strategy Officer
avatar for Jared Katz

Jared Katz

Veeva Systems, United States
Sr. Director, Development Cloud Strategy
avatar for Terry Katz

Terry Katz

Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional...
PK

Philip Kelly

Health Products Regulatory Authority (HPRA), Ireland
IVDR Project Manager | Assessment and Surveillance
SK

Shia Kent

Amgen, United States
Epidemiologist, Pharmacovigilance Epi and Causal Inference Team
KK

Katelyn Keyloun

AbbVie, United States
Director, R&D Digital and Data Strategy
avatar for Irfan Khan

Irfan Khan

Circuit Clinical, United States
Founder and Chief Executive Officer
avatar for Aman Khera

Aman Khera

Worldwide Clinical Trials, Canada
Vice President, Regulatory Science & Innovation
avatar for Aditi Khurana

Aditi Khurana

Summit Therapeutics, Inc., United States
Director, Project Management
avatar for James Kim

James Kim

University of Southern California, United States
Undergraduate Student Researcher
avatar for Jennifer Kim

Jennifer Kim

Tufts Center for the Study of Drug Development, United States
Research Assistant Professor
avatar for Tamy Kim

Tamy Kim

FDA, United States
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of...
avatar for Susan Kindig

Susan Kindig

United States
Prior Executive Director, Medical and Drug Safety
BK

Bellinda King-Kallimanis

Lungevity Foundation, United States
Senior Director of Patient-Focused Research
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

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

Jesper Kjaer

Novo Nordisk, Denmark
Global Director for Public, Private Partnerships, Strat Ops, Global...
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Merck Sharp & Dohme LLC, Czech Republic
Technology Auditor and Quality Projects Lead
CK

Chaitanya Koduri

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

Daisuke Koga

Ministry of Health, Labour and Welfare (MHLW), Japan
Director, Office of International Regulatory Affairs
avatar for Evdokia Korakianiti

Evdokia Korakianiti

European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
GK

George Kordzakhia

AstraZeneca, United States
Statistical Sciences Senior Director
avatar for Mark Kryah

Mark Kryah

Ultragenyx Pharmaceutical Inc., United States
Executive Director, Program Team Leader, Program and Portfolio...
MK

Matthew Kumar

Bayer, Canada
Associate Director, Lead Computational Scientist
RK

Rutendo Kuwana

World Health Organization (WHO), Switzerland
Team Lead, Incidents and Substandard/Falsified Medical Products
KK

Kajsa Kvist

Novo Nordisk, Denmark
Scientific Vice President
avatar for Dominique Lagrave

Dominique Lagrave

Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
avatar for I-Chun Lai

I-Chun Lai

Center for Drug Evaluation, Taiwan
Director, Consultation Division
avatar for Tony Lakavage

Tony Lakavage

USP, United States
Senior Vice President, Global External Affairs
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Affairs – CMC
avatar for Yueh-Wen Lan

Yueh-Wen Lan

Center for Drug Evaluation, Taiwan
Senior Project Manager
avatar for Susan Landis

Susan Landis

Association of Clinical Research Professionals (ACRP), United States
Executive Director
LL

Lara Lane

Ironwood Pharmaceuticals, United States
Director, Clinical Operations
avatar for Samantha Lane

Samantha Lane

Drug Safety Research Unit, United Kingdom
Head of Research, Centre of Pharmacovigilance Sciences
avatar for Connie Langer

Connie Langer

Pfizer Inc, United States
Senior Director
avatar for Juan Lara

Juan Lara

Centre For Innovation In Regulatory Science, Mexico
Senior Research Analyst
avatar for Joseph Laudano

Joseph Laudano

IQVIA, United States
Medical Director
avatar for Marion Laumonier

Marion Laumonier

World Health Organization (WHO), Switzerland
Technical Officer, Regulatory Convergence and Networks
avatar for Anthony Lawler

Anthony Lawler

Therapeutic Goods Administration, Australia
Deputy Secretary, Health Products Regulation Group
avatar for Cathryn Lee

Cathryn Lee

FDA, United States
Director, Office of Program Operations, PDIMS, OND, CDER
avatar for Charles Lee

Charles Lee

AstraZeneca, United States
Executive Regulatory Science Director
avatar for Jennifer Lee

Jennifer Lee

FDA, United States
Senior Health Scientist, Oncology Center of Excellence
avatar for Kerry Jo Lee

Kerry Jo Lee

FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare...
avatar for Mark Lee

Mark Lee

N-Power Medicine, United States
CEO
avatar for Sau Lee

Sau Lee

FDA, United States
Deputy Super Office Director, OPQ, CDER
HV

Hans van Leeuwen

Astellas Pharma Europe BV, Netherlands
Head of Regulatory Operations
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