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avatar for Christine Pierre

Christine Pierre

Society for Clinical Research Sites
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

AbbVie, Inc.
Director, Scientific Regulatory Policy and Intelligence - Latin...
avatar for Kelly Pitts

Kelly Pitts

Corgenix, Inc.
Vice President, Research & Development, Site Manager - Colorado...
avatar for Andrew Porter

Andrew Porter

Merck & Co., Inc.
Director of Enterprise Architecture, IT Planning & Innovation,...
avatar for Jamie Portnoff

Jamie Portnoff

Foresight Group International
Vice President

Philip Posner

Patient-Centered Outcomes Research Institute (PCORI)
Patient Reviewer
avatar for Sarah Powell

Sarah Powell

Powell Regulatory Services
avatar for Sandra Prucka

Sandra Prucka

Eli Lilly and Company
Innovation Lead
avatar for Amy Purrington

Amy Purrington

Janssen Pharmaceuticals, Inc.
Head, Signal Management Group
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American...
avatar for Maria João Queiroz

Maria João Queiroz

Eurotrials Scientific Consultants
Global CEO
avatar for Elizabeth Rager

Elizabeth Rager

Penn Medicine
Corporate Entity Information Officer
avatar for Srinivas Pai Raikar

Srinivas Pai Raikar

Quintiles East Asia Pte Ltd
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF,...
avatar for Sundar Ramanan

Sundar Ramanan

Amgen Inc.
Director, Global Biosimilars R&D Policy

Martina Raskova

avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER
avatar for Stephen Reams

Stephen Reams

Eli Lilly and Company
Advisor, Clinical Project Management
avatar for David Reasner

David Reasner

Albemarle Scientific Consulting LLC
President and Founder

Jayanthi Reddy

Merck & Co., Inc.
Director, Global Project Management
avatar for Sue Rees

Sue Rees

Amgen Ltd
EU QPPV, Executive Director, Global Patient Safety
avatar for John Reites

John Reites

Quintiles Inc.
Senior Director, Head of Digital Health Acceleration
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit
avatar for Margaret Richards

Margaret Richards

Executive Director, Epidemiology and Health Outcomes
avatar for David Richardson

David Richardson

Richardson M.D. Consulting, LLC

Ken Richter


Jesus Rivera

Bristol-Myers Squibb Company
Senior Learning Manager
avatar for James Roberts

James Roberts

Head, Platform Analysis
avatar for Khyati Roberts

Khyati Roberts

AbbVie, Inc.
Head US/Canada, Regulatory Policy and Intelligence

Andrew Robertson

Merck & Co., Inc.
Director, Global Regulatory Policy
avatar for Diane Robertson

Diane Robertson

ECRI Institute
Director, Health Technology Assessment

David Robinson

Robinson Vaccines and Biologics LLC
Principal Consultant
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational...
avatar for Victoria Rocchi

Victoria Rocchi

AnGes, Inc.
Senior Regulatory Affairs Specialist
avatar for Ann Rockley

Ann Rockley

The Rockley Group Inc.
Chief Executive Officer
avatar for Lucy Rose

Lucy Rose

Lucy Rose and Associates, LLC
avatar for Steve Rosenberg

Steve Rosenberg

Oracle Health Sciences
Senior Vice President and General Manager, Health Sciences Global...
avatar for Mark Rosolowsky

Mark Rosolowsky

Bristol-Myers Squibb Company
Vice President, Global Regulatory Sciences, CMC
avatar for Jennifer Ross

Jennifer Ross

Almac Clinical Technologies
Lead Biostatistician
avatar for Matthew Rotelli

Matthew Rotelli

Eli Lilly and Company
Director, Global PK/PD and Pharmacometrics
avatar for Karen Roy

Karen Roy

Senior Vice President, Client Solutions
avatar for Upal Basu Roy

Upal Basu Roy

LUNGevity Foundation
Director of Translational Research Program/Director of Patient FoRCe
avatar for Yury Rozenman

Yury Rozenman

Qualcomm Life
Director, Business Development

Eric Rubin

Merck Research Laboratories
Vice President and Therapeutic Area Head

Annalisa Rubino

Oxon Epidemiology
Director of Risk Management Epidemiology
avatar for Jonathan Rubright

Jonathan Rubright

National Board of Medical Examiners
avatar for Shelley Rusincovitch

Shelley Rusincovitch

Duke Translational Research Institute
Project Leader in Applied Informatics and Architecture
avatar for Colleen Russell

Colleen Russell

Associate Director, Biostatistics

Patrick Ryan

Janssen Pharmaceuticals, Inc.
Head, Epidemiology Analytics
avatar for Bettina Ryll

Bettina Ryll

Melanoma Patients
Chair ESMO Patient Advocates Working Group (PAWG)

Christine Sahagian

Shire US Inc
Head, Clinical and Medical QA and Compliance
avatar for Matt Salo

Matt Salo

National Association of Medicaid Directors
Executive Director
avatar for Dennis Salotti

Dennis Salotti

The Avoca Group
Vice President, Operations
avatar for Kathy Salzano

Kathy Salzano

Merck & Co., Inc.
Director, Quality and Continuous Improvement
avatar for Leslie Sam

Leslie Sam

Eli Lilly and Company
Director, Global Quality Systems, Safety, Efficacy and Customer...

Mikhail Samsonov

Chief Medical Officer
avatar for Nithin Sashidharan

Nithin Sashidharan

Pharm-Olam International
Senior Medical Advisor
avatar for Junko Sato

Junko Sato

Pharmaceuticals and Medical Devices Agency (PMDA)
Office Director, Office of International Cooperation
avatar for Zuben Sauna

Zuben Sauna

Principal Investigator, OTAT, CBER
avatar for Brian Saxby

Brian Saxby

Neurocog Trials Inc.
Vice President, Business Development
avatar for Joseph Scheeren

Joseph Scheeren

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

Richard Scheyer

Vice President, Medical

Maria Schick

Amgen Inc.
CMC Integration Sr. Project Manager
avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance
avatar for Drew Schiller

Drew Schiller

Co-Founder and Chief Technology Officer

Sven Schirp

Boehringer Ingelheim Pharma GmbH & Co. KG
Head of Global Pharmacovigilance Writing
avatar for Scott Schliebner

Scott Schliebner

PRA Health Sciences
Senior Vice President, Center for Rare Diseases
avatar for Roslyn Schneider

Roslyn Schneider

Pfizer Inc
Global Patient Affairs Lead
avatar for Heike Schoepper

Heike Schoepper

Merck KGaA
Head of Global Drug Safety

Lisa Schoyer

Founder and Board President
avatar for David Schubert

David Schubert

Stealth BioTherapeutics
Vice President of Regulatory and Quality
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER
avatar for Duane Schulthess

Duane Schulthess

Vital Transformation
Managing Director

Hermann Schulz

Synlab Pharma Institute
Executive Vice President
avatar for Jodi Schuttig

Jodi Schuttig

Merck & Co., Inc.
Director, Knowledge Management
avatar for Ko Sekiguchi

Ko Sekiguchi

DIA Japan
Senior Vice President and Managing Director
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and...
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and...

Marjan Sepassi

Actelion Pharmaceuticals US Inc
Medical Communication Manager
avatar for Beatrice Setnik

Beatrice Setnik

INC Research
Vice President, Clinical Pharmacology, Early Phase

Meredith Sewell

Director, Global Regulatory Publishing

Nancy Shadeed

Health Canada
Special Advisor, International Programs Division

Patterson Shafer

Deloitte Consulting LLP
Specialist Leader
avatar for Jui Shah

Jui Shah

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

Shivani Shah

Rutgers, The State University of New Jersey
PharmD Candidate, Ernest Mario School of Pharmacy
avatar for Saad Shakir

Saad Shakir

Drug Safety Research Unit

Huda Shalhoub

avatar for Gaurav Sharma

Gaurav Sharma

Actelion Pharmaceuticals US Inc.
Associate Medical Director, Medical Affairs

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER
avatar for Sonja Sharpe

Sonja Sharpe

Director, Technology Development, Advanced Manufacturing Technologies

Tulin Shekar

Merck & Co., Inc.
Associate Principle Statistician

Claire Sheridan

Iroko Pharmaceuticals, LLC
Manager, Clinical Operations
avatar for Jeffrey Sherman

Jeffrey Sherman

Horizon Pharma, Inc.
Chief Medical Officer and Executive Vice President, Research and...
avatar for Shoyo Shibata

Shoyo Shibata

Keio University
PhD Candidate, Faculty of Pharmacy
avatar for Mollie Shields-Uehling

Mollie Shields-Uehling

Safe-BioPharma Association
President and Chief Executive Officer

Carrie Shults

Lyophilization Technology, Inc.
Development Group Leader, Research Scientist
avatar for Leigh Shultz

Leigh Shultz

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

Tai Wai Shun

Medical Reviewer

Ellen Sigal

Friends of Cancer Research
Chairperson and Founder
avatar for Catherine Sigler

Catherine Sigler

UBC, An Express Scripts Company
Executive Director, Safety, Epidemiology, Registries, and Risk...
avatar for Valerie Simmons

Valerie Simmons

Eli Lilly and Company Ltd
EU QPPV, Global Patient Safety
avatar for Camilla Simpson

Camilla Simpson

BioMarin Pharmaceutical Inc.
Group Vice President Regulatory Affairs
avatar for Trisha Simpson

Trisha Simpson

UCB Biosciences, Inc.
Director, Global Biometry Standards
avatar for Dinesh Singh

Dinesh Singh

Client Partner, Life Sciences

Jeffrey Skene

Health Canada
Division Chief, Monoclonal Antibodies
avatar for John Skerritt

John Skerritt

Department of Health
Deputy Secretary for Health Products Regulation
avatar for Mary Ann Slack

Mary Ann Slack

Acting Director, Office of Strategic Programs, CDER
avatar for Ashley Slagle

Ashley Slagle

Aspen Consulting, LLC
Principal, Scientific and Regulatory Consulting
avatar for Nancy Smerkanich

Nancy Smerkanich

University of Southern California
Assistant Professor, Department of Regulatory & Quality Sciences,...

Louis Smith

ICON plc
Data Science Manager

Mary Ann Smith

Novartis Pharmaceuticals Corporation
DRA Policy Head of Medical Device and Combination Products
avatar for Maureen Smith

Maureen Smith

Canadian Organization For Rare Disorders (CORD)
Patient Advocate / Secretary
avatar for Meredith Smith

Meredith Smith

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

Nancy Smith

Temple University, FDA Alumni
Adjunct Professor
avatar for William Smith

William Smith

Alliance for Multispecialty Research/NOCCR
avatar for Jennifer Snow

Jennifer Snow

Director, Health Policy

Morten Sogaard

Pfizer Inc
Vice President and Head, Enterprise Scientific Technology Operations

Fenan Solomon

Rutgers University
Regulatory Affairs
avatar for Lene Sommer

Lene Sommer

Novo Nordisk A/S
Vice President, RA Devices

Seung Yeon Song

Chung-Ang University College of Pharmacy
PhD candidate
avatar for Alfred Sorbello

Alfred Sorbello

Medical Officer, Office of Translational Sciences, CDER
avatar for Aaron Sorensen

Aaron Sorensen

Digital Science
Director, Data Science Insights
avatar for Ian Sparks

Ian Sparks

Medidata Solutions Worldwide
Senior Director, Research Science
avatar for Oliver Steck

Oliver Steck

Navitas Inc.
avatar for David Stein

David Stein

D. Bartley Consulting
Independent eClinical Consultant
avatar for Gary Steinman

Gary Steinman

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 Lisa Stockbridge

Lisa Stockbridge

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
avatar for Teri Stokes

Teri Stokes

Cytel Inc.
Director, Quality Assurance Compliance

Pieter Stolk

Escher, the Lygature Platform For Regulatory Innovation
Program Manager

Pieter Stolk

University Medical Centre Utrecht
Project Manager
avatar for Walter Straus

Walter Straus

Merck & Co., Inc.
Associate Vice President, Therapeutic Area Head, Clinical Safety and...
avatar for Tim Strauss

Tim Strauss

QI Path
President, Quality Solutions
avatar for Marian Strazzeri

Marian Strazzeri

Mathematical Statistician, OB, OTS, CDER

James Streeter

Oracle Health Sciences
Vice President, Life Sciences Strategy
avatar for Jeffrey Stuart

Jeffrey Stuart

Novartis Pharmaceuticals Corporation
Director, Regulatory Affairs
avatar for Jeffrey Stuart

Jeffrey Stuart

Novartis Pharmaceuticals Corporation
Director, Regulatory Affairs
avatar for Nina Stuccio

Nina Stuccio

Merck Research Laboratories
Therapeutic Area Lead, Clinical Safety and Risk Management, Oncology,...
avatar for Lea Studer

Lea Studer

SCORR Marketing
Senior Vice President of Marketing Communications

Annie Sturgess

Bristol-Myers Squibb Company
Vice President, Global Regulatory Sciences, CMC
avatar for Ling Su

Ling Su

Sidley Austin LLP
Strategic Advisor, Life Sciences

Jinuk Suh

Chung-Ang University
avatar for Linda Sullivan

Linda Sullivan

Metrics Champion Consortium LLC
Co-Founder and President
avatar for Michael Swit

Michael Swit

Illumina, Inc.
Senior Director, Legal, Regulatory
avatar for Nick Sykes

Nick Sykes

Pfizer Ltd.
Senior Director, Worldwide Regulatory Strategy
avatar for Ivone Takenaka

Ivone Takenaka

Bristol-Myers Squibb Company
Associate Director, GRSB-CMC and LATCAN Reg Expert
avatar for Dipti Tankala

Dipti Tankala

Astellas Pharma Canada Inc.
Associate Medical Information Manager
avatar for Vadim Tantsyura

Vadim Tantsyura

Target Health Inc.
Director, Data Management

Pelin Tanyeri

Sakarya University
Associate Professor, Department of Medical Pharmacology
avatar for Tomiko Tawaragi

Tomiko Tawaragi

Pharmaceuticals and Medical Devices Agency (PMDA)
Chief Safety Officer
avatar for Elaine Taylor

Elaine Taylor

INC Research
Executive Director, Regulatory Consulting and Submissions
avatar for Margaret Taylor

Margaret Taylor

Genentech, A Member of the Roche Group
Associate Director, Oncology Program Group Leader, Clinical Operations

Ron Taylor

Seattle Genetics, Inc.
Director, Clinical Trial Management
avatar for Steven Taylor

Steven Taylor

Sjögren's Syndrome Foundation
Chief Executive Officer
avatar for Rehbar Tayyabkhan

Rehbar Tayyabkhan

Bristol-Myers Squibb Company
Executive Director, Global Clinical Operations
avatar for Stacy Tegan

Stacy Tegan

Sr. Manager, Regulatory Technology Consulting
avatar for Pamela Tenaerts

Pamela Tenaerts

Clinical Trials Transformation Initiative (CTTI)
Executive Director
avatar for Sameer Thapar

Sameer Thapar

Oracle, Inc. | Rutgers University
Director & Professor, Global Pharmacovigilance
avatar for Sameer Thapar

Sameer Thapar

Oracle HSC
Global Pharmacovigilance Director

Suneela Thatte

Quintiles Research Pvt Ltd
Vice President, Global Operations

Marc Theoret

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

Victoria Thomas

National Institute For Health and Care Excellence (NICE)
Head of Public Involvement, Public Involvement Programme
avatar for Bradley Thompson

Bradley Thompson

Epstein, Becker and Green P.C.
General Counsel, Combination Products Coalition
avatar for Hershell Thompson

Hershell Thompson

Navitas Life Sciences, Inc.
Managing Consultant
avatar for Michelle Thompson

Michelle Thompson

FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Vice President
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Pharmaceuticals and Medical Devices Agency (PMDA)
Associate Executive Director (for International Programs)
avatar for Lesia Tontisakis

Lesia Tontisakis

Director, Pharmacovigilance, Global Patient Safety and Epidemiology
avatar for Francois Torche

Francois Torche

Chief Executive Officer
avatar for Lauren Tornetta

Lauren Tornetta

Pfizer Inc
Director, Global Regulatory Affairs
avatar for Andrew Townshend

Andrew Townshend

INC Research
Senior Vice President, Alliance Development
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader
avatar for Paul Travis

Paul Travis

Exec. Director, Medpace Global Labs
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Daiichi Sankyo Co., Ltd.
Vice President, New Drug Regulatory Affairs
avatar for Sean Tunis

Sean Tunis

Center For Medical Technology Policy (CMTP)
Senior Strategic Advisor
avatar for Diane Turner-Bowker

Diane Turner-Bowker

Adelphi Values
Director, Patient-Centered Outcomes
avatar for Sara Tylosky

Sara Tylosky

avatar for Akio Uemura

Akio Uemura

Allergan Japan K.K.
Executive Director, Head of Japan Development

Tomihiro Umeda

Nara Medical University
Professor, Center for Academic, Industrial and Government Relations
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Pharmaceuticals and Medical Devices Agency (PMDA)
Director, Office of Medical Informatics and Epidemiology
avatar for Mary Lou Valdez

Mary Lou Valdez

Associate Commissioner for International Programs, Office of the...
avatar for Eric Valentine

Eric Valentine

Catalent Pharma Solutions
Global Director, Clinical Distribution Services
avatar for James Valentine

James Valentine

Hyman, Phelps & McNamara, PC
avatar for Alexander Varond

Alexander Varond

Goodwin Procter LLP

Shilpa Venkatachalam

Global Healthy Living Foundation
Research Associate
avatar for Kevin Venner

Kevin Venner

Almac Clinical Technologies
Biostatistician II
avatar for Andrew Verderame

Andrew Verderame

Pharmalex US Regulatory
avatar for Brett Villagrand

Brett Villagrand

avatar for Anu Virkar

Anu Virkar

IBM Watson Health
Vice President, Quality and Compliance, eClinical
avatar for Joachim Vollmar

Joachim Vollmar

International Clinical Development Consultants LLC (ICDC)
Executive Consultant

Natalia Vostokova

Chief Operating Officer

Lucie Vu

MCPHS University
Postdoctoral Fellow

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