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avatar for Anne-Virginie Eggimann

Anne-Virginie Eggimann

bluebird bio, Inc.
Senior Vice President, Regulatory Science
avatar for Hans-Georg Eichler

Hans-Georg Eichler

European Medicines Agency, European Union
Senior Medical Officer

Celeste Elash

Scientist, Consulting
avatar for Bela Elkin

Bela Elkin

Laboratory Manager

William Erhardt

Pfizer Inc
Vice President, Global Product Development
avatar for Robert Erwin

Robert Erwin

Marti Nelson Cancer Foundation
avatar for Denise Esposito

Denise Esposito

Covington & Burling LLP
avatar for Dave Evans

Dave Evans

Managing Director

Manon Exposito

Universal Medica
Pharmacist Project Manager
avatar for Rhonda Facile

Rhonda Facile

Vice President, Development Opportunities
avatar for Mor Fall

Mor Fall

University Cheikh Anta Diop/Université Claude Bernard Lyon1, France
PhD Student, Service of Clinical Pharmacology, EMET/FMPO
avatar for Betsy Fallen

Betsy Fallen

BAFallen Consulting LLC

Daphne Farrington

Eli Lilly and Company
Clinical Research Scientist

Bella Feng

Amgen Inc
Statistical Programming Manager
avatar for Robert Ferendo

Robert Ferendo

Eli Lilly and Company
Consultant-Process & Technology
avatar for Andrea Ferris

Andrea Ferris

LUNGevity Foundation
President and Chairman
avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC
avatar for Marta Fields

Marta Fields

Seattle Genetics, Inc.
Senior Director, Research & Development Quality
avatar for Owen Fields

Owen Fields

Pfizer Inc
Vice President, Inflammatory and Immunology, WW Safety and Regulatory
avatar for Eva Finney

Eva Finney

Merck & Co., Inc.
Director, Global Project & Alliance Management
avatar for Joseph Fiore

Joseph Fiore

Merck & Co., Inc.
Senior Clinical Scientist
avatar for Kristin Fitzgerald

Kristin Fitzgerald

Merck & Co., Inc.
Director, Global Project Management, Project Management Office
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER
avatar for Jessica Foley

Jessica Foley

NovusLife, LLC
Head of Regulatory Services
avatar for Kathleen Foley

Kathleen Foley

Pfizer Inc.
Senior Director
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

Trilogy Writing & Consulting
President/Senior Partner

Richard Forshee

Associate Director for Research, Office of Biostatistics and...
avatar for Joseph Fortunato

Joseph Fortunato

inVentiv Health Clinical
Senior Vice President, Corporate Quality Assurance and Compliance
avatar for Mick Foy

Mick Foy

Medicines and Healthcare products Regulatory Agency (MHRA)
Group Manager, Vigilance Intelligence and Research Group
avatar for Jeffrey Francer

Jeffrey Francer

Pharmaceutical Research and Manufacturers of America (PhRMA)
Vice President and Senior Counsel
avatar for Henry Francis

Henry Francis

Director for Data Mining and Informatics Evaluation and Research,...
avatar for Tammy Franklin

Tammy Franklin

Head of Global Medical Writing
avatar for Lynn Fraser

Lynn Fraser

BioClinica, Inc.
Senior Product Manager

Sue Friedman

Facing Our Risk of Cancer Empowered (FORCE)
Executive Director and Founder
avatar for David Fryrear

David Fryrear

AbbVie, Inc.
Senior Director, R&D Quality Assurance
avatar for Joseph Fulginiti

Joseph Fulginiti

Rutgers, The State University of New Jersey
Post-Doctoral Fellow, Clinical Development and Medical Affairs
avatar for Carrie Furin

Carrie Furin

Eli Lilly and Company
Manager, Clinical Trial Management
avatar for Patricia Furlong

Patricia Furlong

Parent Project Muscular Dystrophy
Founding President and CEO

Zachary Furqueron

Pfizer Inc
Director/Team Leader, Analytics and Reporting Group, External Medical...
avatar for Sara Gagneten

Sara Gagneten

Associate Div Director, Policy, Office of Vaccines Research and...
avatar for Bruno Gagnon

Bruno Gagnon

Myokardia, Inc.
Executive Consultant, Clinical Operations
avatar for Steven Galson

Steven Galson

Amgen Inc.
Senior Vice President, Global Regulatory Affairs and Safety
avatar for Steven Galson

Steven Galson

Amgen Inc.
Senior Vice President, Global Regulatory Affairs and Safety
avatar for Shelley Gandhi

Shelley Gandhi

NDA Group
Strategic Advisor, Pharmacovigilance and Drug Safety
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

European Medicines Agency, European Union
Head of Product Development Scientific Support Department
avatar for Sarah Garner

Sarah Garner

National Institute for Health and Care Excellence (NICE)
Associate Director – Science Policy and Research
avatar for Elizabeth Garrard

Elizabeth Garrard

Clinipace Worldwide
Executive Vice President, Global Safety Operations
avatar for Louis Garrison

Louis Garrison

University of Washington
Professor, Pharmaceutical Outcomes Research and Policy Program

Timothy Garver

Impact Pharmaceutical Services
Chief Operating Officer and Executive Vice President
avatar for Andrew Garvey

Andrew Garvey

Global Patient Advocacy Lead
avatar for Charu Gautam

Charu Gautam

Senior Medical Director
avatar for Helle Gawrylewski

Helle Gawrylewski

Janssen Research & Development, LLC
Senior Director, Medical Writing and Alliance Management
avatar for Stewart Geary

Stewart Geary

Eisai Co., Ltd.
Senior Vice President, Chief Medical Officer
avatar for Arnold Gelb

Arnold Gelb

EMD Serono Research & Development Institute, Inc.
Senior Director, Clinical Biomarkers and Companion Diagnostics
avatar for Cynthia Geoghegan

Cynthia Geoghegan

Patients and Partners LLC
Patient Representative
avatar for Art Gertel

Art Gertel

MedSciCom, LLC
President and Principal Consultant
avatar for Heidi Gertner

Heidi Gertner

Hogan Lovells US LLP
avatar for Kenneth Getz

Kenneth Getz

Tufts Center For the Study of Drug Development
Deputy Director, Research Professor
avatar for Dalvir Gill

Dalvir Gill

TransCelerate BioPharma Inc.
Chief Executive Officer
avatar for Caoimhe Vallely Gilroy

Caoimhe Vallely Gilroy

Biomarker Operations Therapeutic Area Leader, I2ON
avatar for Lucas Glass

Lucas Glass

Head of Machine Learning Research
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance
avatar for Richard Gliklich

Richard Gliklich

Better Outcomes
Chief Executive Officer
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Janssen Research & Development, LLC
Associate Director, Biostatistics
avatar for Christian Gossens

Christian Gossens

F. Hoffmann-La Roche Ltd.
Global Head, Early Development Workflows

Beverly Gow

Director of Pharmacovigilance Support Services

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER
avatar for Michael Gray

Michael Gray

Vice President and Chief Operating Officer, The Resource Group
avatar for Kevin Grebner

Kevin Grebner

AbbVie, Inc.
Director, Clinical Quality Assurance
avatar for Kimberly Greco

Kimberly Greco

Amgen Inc.
Director, Research and Development Policy
avatar for Howard Greenberg

Howard Greenberg

Janssen Research and Development, LLC
Medical Safety Officer
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President

Lindsay Groff

Barth Syndrome Foundation
Executive Director
avatar for Niels Gronning

Niels Gronning

Principal Consultant
avatar for Diane Gross

Diane Gross

Lupus Research Institute
National Program Director
avatar for Qing Gu

Qing Gu

Pfizer Investment Co., Ltd
Sr. Study and Publication Manager, Medical Strategy and Operations...

Ashok Gupta

Vice President, Head of Clinical Immuno-Oncology
avatar for Chad Gwaltney

Chad Gwaltney

Gwaltney Consulting
Principal Consultant
avatar for Tilo Hache

Tilo Hache

Novartis Pharma AG
Work Stream Leader Mobile Patient Data
avatar for Adam Hacker

Adam Hacker

Janssen Pharmaceuticals (johnson & Johnson)
Vice President, Head of Vaccines & Microbiome, Global Regulatory...
avatar for Jonathan Haddad

Jonathan Haddad

Director, Clinical Statistics

Christine Hall

Director, eCOA Product and Clinical Science Marketing

Marni Hall

Director, Regulatory Science Staff, OSE, CDER
avatar for Michael Hamrell

Michael Hamrell

MORIAH Consultants
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy
avatar for Bill Hanlon

Bill Hanlon

Covance Inc.
Chief Development Officer and Head of Global Regulatory Affairs

Kristin Hanson

UBC: An Express Scripts Company
Scientific Consultant
avatar for Nick Hargaden

Nick Hargaden

President, US Operations
avatar for Rave Harpaz

Rave Harpaz

Oracle Health Sciences
Senior Research Scientist
avatar for Beth Harper

Beth Harper

Clinical Performance Partners, Inc.

Shirley Harris

avatar for Beverly Harrison

Beverly Harrison

Janssen Pharmaceutical Companies of Johnson & Johnson
Head, Patient Support
avatar for Judy Harrison

Judy Harrison

Chief Medical Officer
avatar for Rick Hart

Rick Hart

BioStorage Technologies
Director of Global Technology Solutions

Sema Hashemi

Director, Office of Regional and Country Affairs, OIP, OC
avatar for Sabine Haubenreisser

Sabine Haubenreisser

European Medicines Agency, European Union
Liaison to the US FDA
avatar for Karen Hauda

Karen Hauda

Novo Nordisk A/S
Senior Director, Regulatory Policy
avatar for Conrad Hawkins

Conrad Hawkins

KMR Group Inc.
Associate Consultant
avatar for Richard Heaslip

Richard Heaslip

Programmatic Sciences LLC
avatar for Marie-Agnes Heine

Marie-Agnes Heine

European Medicines Agency, European Union
Head of Communication Department, Stakeholders and Communication...
avatar for Jonathan Helfgott

Jonathan Helfgott

Johns Hopkins University
Coordinator for Regulatory Science Program
avatar for Deborah Henderson

Deborah Henderson

Merck & Co., Inc.
Executive Director, Global Regulatory Policy

Thomas Henkel

Targos GmbH Biomarker Services
Chief Executive Officer and Co-Founder

Lisa Heral

Fibrous Dysplasia Foundation
Board of Director and Registry Coordinator

Adrian Hernandez

Duke Clinical Research Institute (DCRI)
Co-Private Investigator, PCORnet Coordinating Center, Professor of...

Graciela Gonzalez Hernandez

Arizona State University
Associate Professor, Department of Biomedical Informatics
avatar for Ben Heywood

Ben Heywood

President and Co-Founder
avatar for Brandon Higgs

Brandon Higgs

avatar for Robert Hilke

Robert Hilke

Hilke Communications Corporation
Chief Executive Officer
avatar for Walter Hinz

Walter Hinz

Celgene Corporation
Senior Director
avatar for Brad Hirsch

Brad Hirsch

Flatiron Health
Senior Medical Director
avatar for Gigi Hirsch

Gigi Hirsch

Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Executive Director

Heather Hixon

Experient, Inc.
avatar for Julie Ho

Julie Ho

Associate Director, Business and Market Development
avatar for John Hoffman

John Hoffman

Johnson & Johnson
Senior Director, Health Policy, Advocacy and Quality
avatar for Michelle Hoiseth

Michelle Hoiseth

Parexel International
Chief Data Officer, Scientific Data Organization
avatar for JB Van Hollen

JB Van Hollen

Van Hollen Consulting, LLC
Former State Attorney General for Wisconsin
avatar for Kristen Hollingsworth

Kristen Hollingsworth

Johnson & Johnson
Global Business Leader, Diagnostics-Oncology

Anthony Holmes

Head, Technology Development
avatar for Elisa Holzbaur

Elisa Holzbaur

Almac Group
Manager, ePRO Services
avatar for Anton Hoos

Anton Hoos

Amgen GmbH
Vice President and Medical Director, Europe
avatar for Angelique Hopkins

Angelique Hopkins

Bristol-Myers Squibb Company
Associate Director Clinical Trial Analytics
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Eli Lilly and Company
Consultant, RBM Operations, Clinical Risk Management
avatar for Jane Horvath

Jane Horvath

3D Communications
Market Access Lead
avatar for Hiroshi Hosoi

Hiroshi Hosoi

Nara Medical University
avatar for Sally Howard

Sally Howard

Human Longevity, Inc.
Head of Regulatory Affairs and Policy
avatar for Deborah Howe

Deborah Howe

Bristol-Myers Squibb
Associate Director, Vendor Alliance Lead
avatar for Helen Howitt

Helen Howitt

INC Research
Director, Process Quality Management
avatar for Cindy Howry

Cindy Howry

YPrime Inc
Vice President, Product Strategy and Innovation

Jinjie Hu

Biologics Consulting Group
co-chair of FDAAA International Network committee; Senior Consultant
avatar for Frank Hubbard

Frank Hubbard

Global Regulatory Writing Solutions Inc.
avatar for John Hubbard

John Hubbard

President and Chief Executive Officer

Kristin Hudson

avatar for Kevin Hudziak

Kevin Hudziak

Eli Lilly and Company
Consultant, Innovation Lead

Earl Hulihan


Rebecca Hummel

CNS Healthcare
Quality Manager
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER
avatar for Carolyn Hynes

Carolyn Hynes

Senior Director, Global Regulatory Intelligence
avatar for Michael Ibara

Michael Ibara

Fathom Digital Healthcare Consulting
Managing Partner
avatar for Ekopimo Ibia

Ekopimo Ibia

Merck & Co., Inc; FDA Alumni Association International Network
Director, Medical Safety Review
avatar for Mattheus Van Iersel

Mattheus Van Iersel

PRA Health Sciences
Senior Director, Scientific Affairs - Clinical Pharmacology

Covance Inc.

Covance Inc.

SAS Institute Inc.

SAS Institute Inc

Yumi Inoue

SOUSEIKAI Global Clinical Research Center

Speaker Invited

Health Canada
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER

Masanori Ito

Astellas Pharma Global Development, Inc.
Senior Biostatistics Manager
avatar for Teiki Iwaoka

Teiki Iwaoka

CAC Croit Corporation
Executive Consultant, Director of Drug Safety Outsourcing Planning
avatar for Rima Izem

Rima Izem

Lead Mathematical Statistician, Office of Translational Science, CDER
avatar for Maria Guazzaroni Jacobs

Maria Guazzaroni Jacobs

Pfizer Inc
Director, Quality and Regulatory Policy (QRP)

Laxman Jakkala

Director, Global Quality Assurance
avatar for Lisa Chamberlain James

Lisa Chamberlain James

Trilogy Writing & Consulting Ltd.
Senior Partner
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor
avatar for John Jenkins

John Jenkins

Director, Office of New Drugs, CDER
avatar for Diane Johnson

Diane Johnson

Johnson & Johnson
Senior Director, North American Regulatory Affairs Policy and...

Otis Johnson

Vice President, Feasibility & Clinical Informatics
avatar for Graeme Johnston

Graeme Johnston

Patient and Member of the Advisory Board of PFMD
avatar for Steve Jolley

Steve Jolley

SJ Pharma Consulting, LLC
Chief Executive Officer
avatar for Vineet Kacker

Vineet Kacker

APCER Life Sciences
Managing Director and Co-founder

Lisa Kammerman

Senior Statistical Science Director
avatar for John Kamp

John Kamp

Coalition For Healthcare Communication
Executive Director
avatar for Paige Kane

Paige Kane

Dublin Institute of Technology/ Merck & Co., Inc.
Regulatory Science Researcher/ Director KM CoE

Gaeun Kang

Chonnam National University Hospital
Fellow, Division of Clinical Pharmacology
avatar for Srinivas Karri

Srinivas Karri

Oracle Corporation
Senior Director, Clinical Warehousing Cloud Strategy
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER
avatar for Mitchell Katz

Mitchell Katz

Purdue Pharma L.P.
Head of Clinical Research and Drug Safety Operations

Joseph Kauten

Shire Pharmaceuticals
Biologics CMC Control Strategy Leader
avatar for Ellen Kelso

Ellen Kelso

Chesapeake IRB
Executive Director
avatar for Susan Kenny

Susan Kenny

Maximum Likelihood, Inc.
avatar for Wasif Khan

Wasif Khan


Laura Khurana

Scientific Advisor

Matthew Kiernan

avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor
avatar for Joseph Kim

Joseph Kim

Eli Lilly and Company
Senior Advisor, Clinical Innovation
avatar for Lisa Kim

Lisa Kim

Rutgers School of Health Professions
Director of Capstone / Lecturer
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
avatar for Lynn King

Lynn King

TKL Research, Inc.
Senior Director, Clinical Operations
avatar for Lillian Kirk

Lillian Kirk

Director, Global Pharmacovigilance Case Management

Robert Kleiman

Chief Medical Officer and Vice President, Global Cardiology
avatar for Agnes Klein

Agnes Klein

Health Canada
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic...
avatar for Robert Klein

Robert Klein

Continuum Clinical
Chief Strategy Officer
avatar for Michael Kleinrock

Michael Kleinrock

IMS Health
Director, IMS Institute For Health Informatics, Research Development
avatar for Craig Klinger

Craig Klinger

Lilly USA, LLC
Consultant, Field Medical Liaison Strategy and Capabilities - Trainer
avatar for Stephen Knowles

Stephen Knowles

Eli Lilly and Company
Senior Director, Global Patient Safety, Medical and Benefit Risk...
avatar for Laura Kolaczkowski

Laura Kolaczkowski

iConquerMS PPRN, PCORnet
Lead Patient Representative, Co-Principal Investigator
avatar for Tetyana Kolodyezna

Tetyana Kolodyezna

National University of Pharmacy
Pharmacy Student

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER
avatar for Tatsuya Kondo

Tatsuya Kondo

Pharmaceuticals and Medical Devices Agency (PMDA)
Chief Executive
avatar for Michael Kopcha

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER
avatar for Carol Koro

Carol Koro

Senior Director, Worldwide Epidemiology

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