avatar for Anja Schaefer

Anja Schaefer

TaRes GmbH
Chief Executive Officer
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer...
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical
avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance
avatar for Scott Schliebner

Scott Schliebner

PRA Health Sciences
Senior Vice President, Center for Rare Diseases
avatar for Hollie Schmidt

Hollie Schmidt

Accelerated Cure Project
VP of Scientific Ops

Stephan Schmidt

University of Florida
Associate Director, Center for Pharmacometrics and Systems...
avatar for Sebastian Schneeweiss

Sebastian Schneeweiss

Harvard Medical School and Brigham & Women's Hospital
Professor of Medicine and Epidemiology
avatar for Roslyn Schneider

Roslyn Schneider

Pfizer Inc
Global Patient Affairs Lead
avatar for Peter Scholes

Peter Scholes

Quotient Clinical
Chief Scientific Officer
avatar for Suzanne Schrandt

Suzanne Schrandt

Arthritis Foundation
Director, Patient Engagement
avatar for David Schubert

David Schubert

Stealth BioTherapeutics
Vice President of Regulatory and Quality
avatar for Duane Schulthess

Duane Schulthess

Vital Transformation
Managing Director
avatar for Joseph Scrocco

Joseph Scrocco

OneWorld Inc.
President and CEO
avatar for James Seaton

James Seaton

Seaton Associates, LLC
Executive Consultant
avatar for Ron Segal

Ron Segal

Pfizer Inc.
Senior Director, Business Technology
avatar for Joe Selby

Joe Selby

Patient-Centered Outcomes Research Institute (PCORI)
Executive Director
avatar for Jenn Sellers

Jenn Sellers

Medical Officer, OSI, OC, CDER
avatar for Thomas Senderovitz

Thomas Senderovitz

Danish Medicines Agency
Chair of HMA Management Group; Director General
avatar for Sundeep Sethi

Sundeep Sethi

AbbVie, Inc.
Vice President
avatar for Ian Shafer

Ian Shafer

Accenture Accelerated R&D Services
Managing Director

Anne Shah

Virginia Commonwealth University
PhD candidate
avatar for Jui Shah

Jui Shah

National Institutes of Health (NIH)
Health Scientist Administrator, NIAID, Clinical Research Resources...
avatar for Saad Shakir

Saad Shakir

Drug Safety Research Unit

Stephanie Shapley

Associate Director for Regulatory Affairs, OMPI, OMP, CDER
avatar for T.J. Sharpe

T.J. Sharpe

Starfish Harbor LLC
Patient Advocate
avatar for Stuart Shaw

Stuart Shaw

Boehringer Ingelheim Pharmaceuticals Inc.
Risk Based Quality Management Project Leader
avatar for Jennifer Shing

Jennifer Shing

Postdoctoral Fellow, Office of New Drugs, CDER
avatar for Mary Short

Mary Short

Eli Lilly and Company
Research Advisor, Clinical, MDU, Medical Pediatric Capabilities
avatar for Leigh Shultz

Leigh Shultz

Merck & Co., Inc.
Associate Vice President, Global Project and Alliance Management

Steve Sibley

Synchrogenix, a Certara Company
Vice President, Global Submissions and Submissions Leadership
avatar for Catherine Sigler

Catherine Sigler

UBC, An Express Scripts Company
Executive Director, Safety, Epidemiology, Registries, and Risk...
avatar for Sarah Ann Silvers

Sarah Ann Silvers

Director, GCP Process Control and Compliance
avatar for Christine Simmon

Christine Simmon

Association for Accessible Medicines (AAM)
Senior Vice President, Policy and Strategic Alliances
avatar for Holli Simmons-Little

Holli Simmons-Little

Lilly USA, LLC
Director, The Lilly Answers Center

Seema Singh

Sasoon Hospital
avatar for Ashley Slagle

Ashley Slagle

Aspen Consulting, LLC
Principal, Scientific and Regulatory Consulting
avatar for Jean Slutsky

Jean Slutsky

Patient-Centered Outcomes Research Institute (PCORI)
Chief Engagement and Dissemination Officer
avatar for Nancy Smerkanich

Nancy Smerkanich

University of Southern California
Assistant Professor, Department of Regulatory & Quality Sciences,...
avatar for Kelly Smith

Kelly Smith

Contracts and Budgets
avatar for Meredith Smith

Meredith Smith

Amgen Inc.
Global Risk Management Officer, Global Patient Safety
avatar for William Smith

William Smith

Alliance for Multispecialty Research/NOCCR
avatar for Sondra Smyrnios

Sondra Smyrnios

Vice President, Clinical Development Operations
avatar for Cathie Snyder

Cathie Snyder

Rho, Inc.
Senior Director, Operations
avatar for Scott Snyder

Scott Snyder

AbbVie, Inc.
Senior Safety Data Scientist
avatar for Elizabeth Somers

Elizabeth Somers

Merck & Co., Inc.
Executive Director of Infectious Disease, Global Project and Alliance...

Priyal Soni

Rutgers, The State University of New Jersey

Michael Sonksen

Eli Lilly and Company
Research Scientist
avatar for Ramana Sonty

Ramana Sonty

Johnson & Johnson
Strategic Business Planning and Execution, Global Medical Organization

Bryan Souder

Merck & Co., Inc. Kenilworth, NJ USA
Associate Director, TMF Head
avatar for James Spears

James Spears


Ginger Spitzer

Foundation of Sarcoidosis Research
Executive Director
avatar for Rajeshwari Sridhara

Rajeshwari Sridhara

Director, Division of Biometric V, Office of Biostatistics, OTS, CDER

Vikesh Srivastava

Health Canada
Associate Director, Business Informatics Division, HPFB
avatar for Alicia Staley

Alicia Staley

Independent Patient Advocate
Patient Advocate
avatar for Paul Stang

Paul Stang

Janssen Research & Development, LLC
Vice President: Global Epidemiology

Abbe Steel

HealthiVibe, LLC
Founder and CEO
avatar for Annette Stemhagen

Annette Stemhagen

SVP & Chief Scientific Officer
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Tufts Center for the Study of Drug Development
Research Fellow
avatar for Jerry Stewart

Jerry Stewart

Pharmaceutical Research and Manufacturers of America (PhRMA)
Deputy Vice President, Scientific and Regulatory Advocacy
avatar for Angela Stokes

Angela Stokes

Syneos Health
Senior Director, Global Regulatory Consulting

Kenneth Stoltzfus

Accenture Accelerated R&D Services
Clinical Data Strategies, Accelerated R&D Life Sciences

Grant Strachan

Bristows LLP
Senior Associate, Regulatory
avatar for Katie Strasser

Katie Strasser

Accenture Accelerated R&D Services
Senior Manager
avatar for Walter Straus

Walter Straus

Merck & Co., Inc.
Associate Vice President, Therapeutic Area Head, Clinical Safety and...

Kristina Strutt

Ipsen Biopharm Limited
Senior Vice President, Global Patient Safety
avatar for Jeffrey Stuart

Jeffrey Stuart

Merck & Co., Inc.
Executive Director, Global Regulatory Affairs
avatar for Robert Studt

Robert Studt

Janssen Pharmaceutical Companies of Johnson & Johnson
Head of Quality Analytics, BioResearch Quality & Compliance
avatar for Ling Su

Ling Su

Shenyang Pharmaceutical University

Helen Sullivan

Social Science Analyst, OPDP, CDER
avatar for Greg Sweatt

Greg Sweatt

Vice President Life Sciences
avatar for Pete Taft

Pete Taft

PharmApprove, a member of the NDA Group
Senior Communications Coach
avatar for Kiyoteru Takenouchi

Kiyoteru Takenouchi

Foundation for Biomedical Research and Innovation (FBRI)
CDISC Program Coodinator, Translational Research Informatics Center...
avatar for Iris Tam

Iris Tam

Otonomy, Inc.
Vice President, Patient Access and Quality
avatar for Rajneesh Taneja

Rajneesh Taneja

TB Alliance
Senior Director, Pharmaceutical Product Development
avatar for Kelli Tanzella

Kelli Tanzella

Thermo Fisher Scientific
Senior Director, Regulatory Affair, Clinical and Compliance Life...
avatar for Jörg Täubel

Jörg Täubel

Richmond Pharmacology Ltd.
Chief Executive Officer
avatar for Roxanne Tavakkol

Roxanne Tavakkol

Mallinckrodt Pharmaceuticals
Vice President, Regulatory Affairs, Autoimmune and Rare Diseases
avatar for Elaine Taylor

Elaine Taylor

INC Research
Executive Director, Regulatory Consulting and Submissions

Kellie Taylor

Associate Director, OMEPRM, OSE, CDER, FDA
avatar for Robert Taylor

Robert Taylor

Merck & Co., Inc.
Director, Safety Systems Management

Jeanette Teague

Bristol-Myers Squibb
Associate Director, eClinical Operations
avatar for Robert Temple

Robert Temple

Deputy Center Director for Clinical Science, Office of the Center...
avatar for Andrea Tenbarge

Andrea Tenbarge

Eli Lilly and Company
Consultant, Medical Digital Strategy and Capabilities

Debbie Tennant

Pfizer Inc.
Director, Medical Information
avatar for Sameer Thapar

Sameer Thapar

Oracle HSC
Global Pharmacovigilance Director

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER
avatar for Mathew Thomas

Mathew Thomas

Country Director, India Office, Office of International Programs, OC
avatar for David Thompson

David Thompson

Inventiv Health
Senior Vice President, Real World Evidence Consulting
avatar for Elaine Thompson

Elaine Thompson

Senior Staff Fellow, OTS, OCS, CDER
avatar for Douglas Throckmorton

Douglas Throckmorton

Deputy Director, Regulatory Programs, OCD, CDER
avatar for Aman Thukral

Aman Thukral

AbbVie, Inc.
Associate Director, DSS
avatar for Dan Tierno

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Pharmaceuticals and Medical Devices Agency (PMDA)
Associate Executive Director (for International Programs)
avatar for Scott Tomsky

Scott Tomsky

Teva Pharmaceutical
Vice President, Regulatory Affairs, Generics, North America
avatar for Fabrizio Tondolo

Fabrizio Tondolo

Merck & Co., Inc.
Global Medical Affairs Lead, Infectious Disease
avatar for Francois Torche

Francois Torche

Chief Executive Officer
avatar for Andrew Townshend

Andrew Townshend

INC Research
Senior Vice President, Alliance Development
avatar for Phil TREGUNNO


Medicines and Healthcare products Regulatory Agency (MHRA)
Group Manager, Vigilance, Intelligence and Research Group
avatar for Ann Marie Trentacosti

Ann Marie Trentacosti

Medical Officer, Labeling Development Team, OND, CDER

Elizabeth Troll

avatar for Alexander Tsiaras

Alexander Tsiaras

Founder & CEO
avatar for Mintu Turakhia

Mintu Turakhia

Stanford University
Executive Director, Center for Digital Health; Chief of EP, Palo Alto...

Mark Turner

International Neonatal Consortium
Senior Lecturer in Neonatology; Co-Director
avatar for Kim Tyrrell-Knott

Kim Tyrrell-Knott

Epstein Becker & Green, P.C.
avatar for Akio Uemura

Akio Uemura

Allergan Japan K.K.
Executive Director, Head of Japan Development
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Pharmaceuticals and Medical Devices Agency (PMDA)
Director, Office of Medical Informatics and Epidemiology
avatar for Shinobu Uzu

Shinobu Uzu

Pharmaceuticals and Medical Devices Agency (PMDA)
Associate Executive Director
avatar for James Valentine

James Valentine

Hyman, Phelps & McNamara, PC
avatar for Alexander Varond

Alexander Varond

Goodwin Procter LLP

Priscilla Velentgas

Senior Director, Epidemiology

Lucy Vereshchagina

Pharmaceutical Research and Manufacturers of America (PhRMA)
Deputy Vice President, Science and Regulatory Advocacy
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Hoffmann-La Roche Ltd.
Head, Customer Strategy Global Medical Affairs
avatar for Cynthia Verst

Cynthia Verst

President, R&D Design and Delivery Innovation

Alex Viehmann

Operations Research Analyst, OS, OPQ, CDER

Kert Viele

Berry Consultants
Director and Senior Statistical Scientist
avatar for Anu Virkar

Anu Virkar

IBM Watson Health
Vice President, Quality and Compliance, eClinical
avatar for Kristin Voorhees

Kristin Voorhees

Continuum Clinical
Senior Manager, Advocacy Relations
avatar for David Vulcano

David Vulcano

Hospital Corporation of America (HCA)
Vice President, Clinical Research Compliance & Integrity
avatar for Rod Walker

Rod Walker

Operations Lead, Quintiles Precision Enrollment

Taylor Walsh

South Carolina College of Pharmacy
Pharmacy Student
avatar for Tatyana Wanderer

Tatyana Wanderer

Synchrogenix, a Certara Company
Director, Strategic Partnership Alliances
avatar for Chao-Yi Wang

Chao-Yi Wang

TFDA, Chinese Taipei
Director, Division of Medicinal Products, Ministry of Health and...
avatar for Nancy Wang

Nancy Wang

Associate Director, Biostatistics
avatar for Susan Wang

Susan Wang

Boehringer Ingelheim Pharmaceuticals Inc.
Director, Biostatistics
avatar for Wei Wang

Wei Wang

Eli Lilly and Company
Senior Research Scientist
avatar for William Wang

William Wang

Merck Research Laboratories
Executive Director, Clinical Safety Statistics, BARDS
avatar for Robert Ward

Robert Ward

University of Utah
Professor Emeritus of Pediatrics, Neonatology, Clinical Pharmacology
avatar for Radek Wasiak

Radek Wasiak

Vice President and General Manager, Real-World Evidence and Meta...
avatar for June Wasser

June Wasser

Reagan-Udall Foundation For the FDA
Executive Director
avatar for Chris Watson

Chris Watson

Director of Product Strategy - Digital Patient

Keith Webber

Perrigo Company plc
Sr. Dir. Rx Regulatory Affairs

Scott Weidley

Chief Executive Officer
avatar for John Weiner

John Weiner

Associate Director for Policy
avatar for Neil Weisman

Neil Weisman

Continuum Clinical
avatar for Karen Weiss

Karen Weiss

Janssen Pharmaceutical Companies of Johnson & Johnson
Vice President, Global Regulatory Affairs
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Business Opeartions, Scientific Data Organization

James Weston

Seres Therapeutics, Inc.
Vice President, Regulatory Affairs
avatar for Kevin White

Kevin White

Celgene Corporation
Director REMS Technology
avatar for Robin Whitsell

Robin Whitsell

Whitsell Innovations, Inc.
avatar for Steven Whittaker

Steven Whittaker

The Avoca Group
Executive Director, Quality Consortium
avatar for John Whyte

John Whyte

Director, Professional Affairs and Stakeholder Engagement, OCD, CDER
avatar for Annette Williams

Annette Williams

Vice President, Lifecycle Safety
avatar for Francine Williams

Francine Williams

Novo Nordisk A/S
Associate Director, Project Management, Trials
avatar for Rebecca Williams

Rebecca Williams

National Institutes of Health (NIH)
Assistant Director, ClinicalTrials.gov, NCBI

Shann Williams

Rho, Inc.
Senior Director, Operations
avatar for John Willmore

John Willmore

BizInt Solutions, Inc.
avatar for Larissa Wilsie

Larissa Wilsie

Merck & Co., Inc.
Senior Specialist, Project Management
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER

Carolyn Winter

AbbVie, Inc.
Director, PV & RA Quality Assurance
avatar for Lesley Wise

Lesley Wise

Wise Pharmacovigilance and Risk Management Ltd
Managing Director
avatar for Robert Wittenberg

Robert Wittenberg

Baxter Healthcare
Associate Director, Regulatory Affairs

Michael Wolf

Northwestern University
Associate Professor, Medicine and Learning Sciences, Associate...
avatar for Fanny Ki Wong

Fanny Ki Wong

Director and Biometric Team Leader
avatar for Liz Wool

Liz Wool

Barnett International
Global Head of Training

BBK Worldwide

BBK Worldwide
avatar for Charles Wu

Charles Wu

Senior Pharmacologist, OPQ, CDER
avatar for Rinah Yamamoto

Rinah Yamamoto

Clinical Science Advisor
avatar for Rinah Yamamoto

Rinah Yamamoto

Senior Clinical Scientific Advisor
avatar for Lun Yang

Lun Yang

Deputy Director, Indication Expansion

Zhimin Yang

China Food and Drug Administration (CFDA)
Division Director, Center for Drug Evaluation

Richard Young

Veeva Systems Inc.
VP, Vault CDMS
avatar for Stephen Young

Stephen Young

Chief Operations Officer
avatar for Susan Yule

Susan Yule

F. Hoffmann-La Roche Ltd.
Senior Global Regulatory Leader
avatar for Kemi Yusuf

Kemi Yusuf

Senior Director, Office of the PST and PPS Portfolio Management
avatar for Tal Zaks

Tal Zaks

Moderna Therapeutics
Chief Medical Officer

Gabriela Zenhausern

World Health Organization (WHO)
Technical Officer, Regulatory Networks and Harmonization Team
avatar for Diane Zezza

Diane Zezza

Novartis Pharmaceuticals Corporation
Vice President and Global Head, Regulatory CMC

Rong Zhang

China Food and Drug Administration (CFDA)
Deputy Chief Technician, Center For Food and Drug Inspection

Weiya Zhang

Mathematical Statistician, OB, Office of Translational Science, CDER
avatar for Zhongwei Zhou

Zhongwei Zhou

Pfizer Inc.
Director, Data Optimization
avatar for Richard Zink

Richard Zink

University of North Carolina at Chapel Hill
Adjunct Assistant Professor
avatar for Barbara Zupancic

Barbara Zupancic

Worldwide Clinical Trials
Director, Patient Recruitment

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