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avatar for Hans-Georg Eichler

Hans-Georg Eichler

European Medicines Agency, European Union
Senior Medical Officer
CE

Celeste Elash

ERT
Scientist, Consulting
avatar for Bela Elkin

Bela Elkin

PPD
Laboratory Manager
WE

William Erhardt

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

Robert Erwin

Marti Nelson Cancer Foundation
President
avatar for Denise Esposito

Denise Esposito

Covington & Burling LLP
Partner
avatar for Dave Evans

Dave Evans

Accenture
Managing Director
ME

Manon Exposito

Universal Medica
Pharmacist Project Manager
avatar for Rhonda Facile

Rhonda Facile

CDISC
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
Consultant
DF

Daphne Farrington

Eli Lilly and Company
Clinical Research Scientist
BF

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

FDA
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

FDA
Sr. Informatics Advisor
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
RF

Richard Forshee

FDA
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

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

Tammy Franklin

UCB
Head of Global Medical Writing
avatar for Lynn Fraser

Lynn Fraser

BioClinica, Inc.
Senior Product Manager
SF

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
ZF

Zachary Furqueron

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

Sara Gagneten

FDA
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
TG

Timothy Garver

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

Andrew Garvey

GlaxoSmithKline
Global Patient Advocacy Lead
avatar for Charu Gautam

Charu Gautam

QuintilesIMS
Head- Early Clinical Development, Asia Pacific
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
Partner
avatar for Kenneth Getz

Kenneth Getz

Center For the Study of Drug Development, Tufts University School of Medicine
Director of Sponsored Research Programs and Associate Professor
avatar for Dalvir Gill

Dalvir Gill

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

Caoimhe Vallely Gilroy

Roche
Biomarker Operations Therapeutic Area Leader, I2ON
avatar for Lucas Glass

Lucas Glass

QuintilesIMS
Head of Machine Learning Research
avatar for Coleen Glessner

Coleen Glessner

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

Richard Gliklich

Better Outcomes
Chief Executive Officer
avatar for Jonathan Goldsmith

Jonathan Goldsmith

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

Robert (Mac) Gordon

Janssen Pharmaceutical Companies of Johnson & Johnson
Biostatistician
avatar for Christian Gossens

Christian Gossens

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

Beverly Gow

PrimeVigilance
Director of Pharmacovigilance Support Services
LG

Laurie Graham

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

Mark Gray

FDA
Senior Project Manager, BSS, CBER
avatar for Michael Gray

Michael Gray

Ascension
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

Parexel
Corporate Vice President
LG

Lindsay Groff

Barth Syndrome Foundation
Executive Director
avatar for Niels Gronning

Niels Gronning

NNIT A/S
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...
AG

Ashok Gupta

Medimmune
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

GlaxoSmithKline
Director, Clinical Statistics
CH

Christine Hall

ERT
Director, eCOA Product and Clinical Science Marketing
MH

Marni Hall

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

Michael Hamrell

MORIAH Consultants
President
avatar for David Handelsman

David Handelsman

d-Wise
Senior Director, Industry Strategy
avatar for David Handelsman

David Handelsman

d-Wise
Senior Director, Industry Strategy
avatar for Bill Hanlon

Bill Hanlon

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

Kristin Hanson

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

Nick Hargaden

Algorics
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.
President
SH

Shirley Harris

SPARGO, Inc.
avatar for Beverly Harrison

Beverly Harrison

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

Judy Harrison

MedDRA MSSO
Chief Medical Officer
avatar for Rick Hart

Rick Hart

BioStorage Technologies
Director of Global Technology Solutions
SH

Sema Hashemi

FDA
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
Founder
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
TH

Thomas Henkel

Targos GmbH Biomarker Services
Chief Executive Officer and Co-Founder
LH

Lisa Heral

Fibrous Dysplasia Foundation
Board of Director and Registry Coordinator
AH

Adrian Hernandez

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

Graciela Gonzalez Hernandez

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

Ben Heywood

PatientsLikeMe
President and Co-Founder
avatar for Brandon Higgs

Brandon Higgs

MedImmune
Director
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
HH

Heather Hixon

Experient, Inc.
avatar for Julie Ho

Julie Ho

DIA
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
Chief Data Officer
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
AH

Anthony Holmes

NC3Rs
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
President
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
JH

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.
President
avatar for John Hubbard

John Hubbard

BioClinica
President and Chief Executive Officer
KH

Kristin Hudson

SPARGO, Inc.
avatar for Kevin Hudziak

Kevin Hudziak

Eli Lilly and Company
Consultant, Innovation Lead
EH

Earl Hulihan

SUTCM
Professor
RH

Rebecca Hummel

CNS Healthcare
Quality Manager
avatar for Virginia Hussong

Virginia Hussong

FDA
Chief, Data Standards Program, CBER
avatar for Virginia Hussong

Virginia Hussong

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

Carolyn Hynes

GlaxoSmithKline
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
CI

Covance Inc.

Covance Inc.
SI

SAS Institute Inc.

SAS Institute Inc
YI

Yumi Inoue

SOUSEIKAI Global Clinical Research Center
Manager
SI

Speaker Invited

Health Canada
avatar for Robert Iser

Robert Iser

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

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

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

Maria Guazzaroni Jacobs

Pfizer Inc
Director, Quality and Regulatory Policy (QRP)
LJ

Laxman Jakkala

MakroCare
Director, Global Quality Assurance
avatar for Lisa Chamberlain James

Lisa Chamberlain James

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

Jonathan Jarow

FDA
Senior Medical Advisor
avatar for John Jenkins

John Jenkins

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

Diane Johnson

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

Otis Johnson

ICON, Plc
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
LK

Lisa Kammerman

AstraZeneca
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
GK

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

FDA
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
JK

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.
President
avatar for Wasif Khan

Wasif Khan

icddr,b
Scientist
LK

Laura Khurana

ERT
Scientific Advisor
MK

Matthew Kiernan

Pharmica
Partner
avatar for Calvin Kim

Calvin Kim

Bayer
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

FDA
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

Alexion
Director, Global Pharmacovigilance Case Management
RK

Robert Kleiman

ERT
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
SK

Scott Komo

FDA
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

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

Carol Koro

GlaxoSmithKline
Senior Director, Worldwide Epidemiology
JK

Joshua Korzenik

Brigham and Women's Hospital
Director, Crohn's and Colitis Center


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