avatar for Kirsten Messmer

Kirsten Messmer

Principal Regulatory Affairs Specialist
avatar for Jason Methia

Jason Methia

Veeva Systems
VP, Vault Site Connect and eTMF
avatar for Matthew Metz

Matthew Metz

Ossium Health
Director of Strategic Partnerships
avatar for Danielle Metzger

Danielle Metzger

Rational Vaccines, United States
Director of Quality Operations and Inspection Readiness
avatar for Nancy Meyerson-Hess

Nancy Meyerson-Hess

Emqt, Germany
Quality Officer
avatar for Kelci Miclaus

Kelci Miclaus

SAS Institute Inc., JMP Division
Sr Manager, Advanced Analytics R&D
avatar for Dina Mikdadi

Dina Mikdadi

Data Scientist
avatar for Jackie Miller-Giles

Jackie Miller-Giles

Covance Inc.
Clinical Scientist
avatar for Leigh Anne Minnier

Leigh Anne Minnier

TransCelerate BioPharma Inc., United States
Communications Manager
avatar for Ganapathy Mohan

Ganapathy Mohan

Merck & Co., Inc., United States
Head of External Affairs (Quality)
avatar for Ryan Moog

Ryan Moog

Cerner Corporation
Director of Research
avatar for Christine Moore

Christine Moore

Organon & Co., United States
Executive Director
avatar for Gregory Moore

Gregory Moore

Corporate Vice President, Health Technology and Alliances
avatar for Susan Morris

Susan Morris

Susan Morris Coaching, United States
Professional Coach

Lisa Mostovoy

Blue Cross Blue Shield Association
Executive Director of Clinical Pharmacy Services
avatar for Eduardo Motti

Eduardo Motti

Trials and Training, Brazil
Chief Executive Officer
avatar for Alexandra Moutet

Alexandra Moutet

UCB Biopharma SPRL
Global Head of Patient Engagement
avatar for Lan Mu

Lan Mu

Bio-Thera Solutions
Vice President
avatar for Willie Muehlhausen

Willie Muehlhausen

Willie Muehlhausen Ltd
Managing Director
avatar for Michelle Mujoomdar

Michelle Mujoomdar

Canadian Agency for Drugs and Technologies in Health (CADTH)
Director, Scientific Affairs, Evidence Standards
avatar for Andrew Mulberg

Andrew Mulberg

Amicus Therapeutics
Head, Senior Vice President, Global Regulatory Affairs
avatar for Jean Mulinde

Jean Mulinde

FDA, United States
Medical Officer, Policy Advisor, Division of Clinical Compliance...
avatar for Theresa Mullin

Theresa Mullin

FDA, United States
Associate Director for Strategic Initiatives, CDER
avatar for Jamie Munro

Jamie Munro

Centre for Innovation in Regulatory Science (CIRS)
Executive Director
avatar for Jim Murphy

Jim Murphy

Chief Executive Officer
avatar for Lindsey Murray

Lindsey Murray

Critical Path Institute, United States
Associate Director, PRO Consortium
avatar for Mary Murray

Mary Murray

National Minority Quality Forum, United States
Vice President, Collaborative Action Networks
avatar for Mary Murray

Mary Murray

National Minority Quality Forum
VP, Collaborative Action Networks
avatar for Garrick Myers

Garrick Myers

Vertex Pharmaceuticals
Director, Technology and Operations Innovation
avatar for Nancy Myers

Nancy Myers

Catalyst Healthcare Consulting, Inc
President and Founder
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation
avatar for Jane Myles

Jane Myles

Labcorp Drug Development, United States
Director, DCT Implementation, Hybrid & Virtual Trials
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director for International Programs and Asia...
avatar for Viraj Narayanan

Viraj Narayanan

COTA Healthcare
Vice President, Life Sciences
avatar for Michael Neidl

Michael Neidl

Clinical Research Consultant, LLC
Senior Clinical Research Executive
avatar for Lauren Neighbours

Lauren Neighbours

Vice President, Regulatory Affairs and Program Management
avatar for Anita Nelsen

Anita Nelsen

Parexel, United States
Executive Vice President, Translational Medicine
avatar for Jennifer Nguyen

Jennifer Nguyen

Pfizer Inc
Director, Patient and Health Impact
avatar for Michelle Nguyen

Michelle Nguyen

University of Maryland School of Pharmacy
Doctor of Pharmacy Candidate, Class of 2021
avatar for Gavin Nichols

Gavin Nichols

Parexel Informatics
Executive Vice President
avatar for Gerrit Nijveldt

Gerrit Nijveldt

Opus Regulatory, United States
Consultant Labeling

Mona Nili

West Virgina University
PhD Student
avatar for Heejung Noh

Heejung Noh

ORISE Fellow, Office of Medical Policy, CDER
avatar for Barbara Novak

Barbara Novak

Kyowa Kirin Pharmaceutical Development, Inc.
Systems and Process Management Lead, Clinical Operations- NA/EU
avatar for Patty Obermaier

Patty Obermaier

Vice President, US Health and Life Sciences
avatar for Johann Odermann

Johann Odermann

JustSo Marketing
avatar for Elisabeth Oehrlein

Elisabeth Oehrlein

National Health Council (NHC)
Senior Director, Research and Programs

Debra Oetzman

Instem LSS Ltd.
Senior Information Scientist, Data Standards Lead

Sarah Ofori

Rutgers University
Post-Doctoral Fellow
avatar for David Olaleye

David Olaleye

SAS Institute Inc., United States
Senior Manager and Principal Research Statistician
avatar for Kim Olsen

Kim Olsen

Janssen Research and Development, United States
Associate Director, Global Regulatory Policy and Intelligence, Global...
avatar for David Onks

David Onks

Sparked Professional Coaching
Founder and Chief Executive Officer
avatar for Karen Ooms

Karen Ooms

Executive Vice President and Head of Statistics

Lucinda Orsini

Associate Chief Science Officer

Daniele Ouellet

Pfizer Inc
Global Head Pharmacometrics
avatar for Bola Oyegunwa

Bola Oyegunwa

Assoc Strategic Planning Director
avatar for Bola Oyegunwa

Bola Oyegunwa

Covance, Inc.
Vice President, Head of Virtual Trials
avatar for Paul O'Donohoe

Paul O'Donohoe

Medidata Solutions, United States
Senior Director, eCOA Product and Science
avatar for Catina O'Leary

Catina O'Leary

Health Literacy Media (HLM)
President and Chief Executive Officer
avatar for Ian O'Shaughnessy

Ian O'Shaughnessy

ICON plc
Director, Business Development, Global Biometrics
avatar for Robert Paarlberg

Robert Paarlberg

Paarlberg & Associates LLC, United States

Todd Page

Eli Lilly and Company
Director, Toxicology

Mike Paglia

Senior Vice President, CMC Operations
avatar for Ulo Palm

Ulo Palm

The APANDEMIC Initiative
avatar for Joanne Palmisano

Joanne Palmisano

Vertex Pharmaceuticals, Inc.
Vice President, Head Global Regulatory Strategy
avatar for Gerald Dal Pan

Gerald Dal Pan

FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
avatar for Janette Panhuis

Janette Panhuis

Population Health Research Institute
Chief Operating Officer
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas

Bhavika Parikh

Ernest Mario School of Pharmacy, Rutgers University
avatar for Bakul Patel

Bakul Patel

FDA, United States
Director, Digital Health Center of Excellence (DHCoE), CDRH
avatar for Shivali Patel

Shivali Patel

Duke University Hospital
Drug Information Resident, GlaxoSmithKline
avatar for Rajneesh Patil

Rajneesh Patil

Head, Clinical Operations Digital Strategy and Analytics
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Science
avatar for Tulika Paul

Tulika Paul

Associate Consultant
avatar for Lisa Peluso

Lisa Peluso

PharmApprove, a Member of the NDA Group
Principal Consultant, Strategic Communications
avatar for Gene Pennello

Gene Pennello

Senior Mathematical Statistician, OSEL, DIDSR, CDRH
avatar for Sondra Pepe

Sondra Pepe

ArisGlobal, United States
Assoc. Vice President, Product Management
avatar for David Pepperl

David Pepperl

Biologics Consulting
Senior Consultant and Nonclinical Group Leader
avatar for Daniel Perez

Daniel Perez

MACRO Trials
Chief Operations Officer
avatar for Rodrigo Perez

Rodrigo Perez

Sanofi, Mexico
Risk Management and Monitoring Lead
avatar for Vada A. Perkins

Vada A. Perkins

Bayer Pharmaceuticals
Executive Director, Regulatory Policy and Intelligence
avatar for Sue Peschin

Sue Peschin

Alliance for Aging Research
President and Chief Executive Officer
avatar for Brianne Peters

Brianne Peters

Firma Clinical Research
Director, Remote Visit Services

David Petullo

Mathematical Statistician, OB, OTS, CDER
avatar for Edmund Pezalla

Edmund Pezalla

Enlightment Bioconsult, LLC
Chief Executive Officer
avatar for Sissi Pham

Sissi Pham

AESARA, United States
Chief Executive Officer

Paul Phillips

FDA, United States
Director (Acting), Office of Program Operations, OND, CDER
avatar for Dominique Pichard

Dominique Pichard

Chief Science Officer
avatar for Andrei Pikalov

Andrei Pikalov

Sunovion Pharmaceuticals, Inc.
Head of Global Medical Affairs
avatar for Andrei Pikalov

Andrei Pikalov

Sunovion Pharmaceuticals, Inc.
Head of Global Medical Affairs
avatar for Jill Platko

Jill Platko

Signant Health
Senior Scientific Advisor
avatar for Vernessa Pollard

Vernessa Pollard

McDermott Will & Emery LLP
Partner, Chair FDA Pratice
avatar for James Polli

James Polli

University of Maryland School of Pharmacy
Prof, Ralph F Shangraw/Noxell Endowed Chair in Industrial...
avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review...
avatar for TK Booker Porter

TK Booker Porter

Greenwich BioSciences, United States
Senior Director, Global Medical Writing and Regulatory Operations
avatar for Philip Posner

Philip Posner

Patient Representative
Retired Academic
avatar for Andrew Potter

Andrew Potter

FDA, United States
Mathematical Statistician, OB, OTS, CDER

Charles Preston

Pan American Health Organization (PAHO)
Advisor, Regulatory System Strengthening for Medicines & Other...
avatar for Sy Pretorius

Sy Pretorius

Executive Vice President, Chief Medical & Scientific Officer
avatar for Beth Price

Beth Price

The Medical Affairs Company
Vice President
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS,...
avatar for Karen Price

Karen Price

Eli Lilly and Company
Research Fellow, Statistical Innovation Center/Design Hub
avatar for Scott Proestel

Scott Proestel

Senior Medical Officer, Biomedical Informatics and Reg Review...
avatar for Erica Prowiser

Erica Prowiser

Global Head of Recruitment and Retention
avatar for Erica Prowisor

Erica Prowisor

Global Head of Recruitment and Retention

Mitali Purohit

CSL Behring, United States
Associate Director
avatar for Angela Qu

Angela Qu

Parexel, United States
Vice President, Translational Medicine
avatar for Janifer Quick

Janifer Quick

ORISE Fellow, Division of Risk Management, OSE, CDER

Janifer Quick

Food and Drug Administration
ORISE Fellow/ Division of Risk Management

Jonathan Quick

Duke Global Health Institute
Adjunct Professor of Global Health
avatar for Anne Radcliff

Anne Radcliff

Senior Director, Global Project Management

Angela Radcliffe

Capgemini Invent
R&D Practice Lead, Life Sciences
avatar for Tim Raducha-Grace

Tim Raducha-Grace

Syneos Health
Senior Vice President, Partnerships
avatar for Ramesh Raghavachari

Ramesh Raghavachari

Chief, Branch I, DPMA1, OLDP, OPQ, CDER
avatar for June Raine

June Raine

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Chief Executive

Anuradha Ramamoorthy

FDA, United States
Policy Lead, OCP, OTS, CDER
avatar for Shariva Ranadive

Shariva Ranadive

Lokmanya Tilak Municipal Medical College
Pharmacology post graduate student
avatar for Asif Rasheed

Asif Rasheed

Review Scientist, OLDP, OPQ, CDER
avatar for Guido Rasi

Guido Rasi

European Medicines Agency
Executive Director
avatar for Jeremy Rassen

Jeremy Rassen

President and Chief Science Officer
avatar for Bhawna Rastogi

Bhawna Rastogi

APCER Life Sciences
Associate Vice President, Pharmacovigilance

Marlen Rattiner

Vice President, Product Management
avatar for Matthew Raymond

Matthew Raymond

Director, Science and Regulatory Policy
avatar for Arie Regev

Arie Regev

Eli Lilly and Company
Chair, Liver and GI Safety Committee
avatar for Peter  Van Reusel

Peter Van Reusel

Chief Standards Officer
avatar for Christian Reyes

Christian Reyes

USC Department of Regulatory Science, United States
Undergraduate Research Associate
avatar for Matthew Reynolds

Matthew Reynolds

IQVIA, United States
Vice President, Real World Evidence
avatar for Boris Reznichenko

Boris Reznichenko

Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Director, Regulatory Operations
avatar for Kim Ribeiro

Kim Ribeiro

AbbVie, Inc.
Therapeutic Area Lead, Patient Centric Clinical Development
avatar for Margaret Richards

Margaret Richards

Evidera, United States
Senior Research Leader, Real World Evidence
avatar for Armin Ritzhaupt

Armin Ritzhaupt

European Medicines Agency
Scientific Administrator
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy
avatar for Amanda Roache

Amanda Roache

Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Senior Director, Science and Regulatory Advocacy
avatar for Steven Roberds

Steven Roberds

Tuberous Sclerosis Alliance, United States
Chief Scientific Officer
avatar for Khyati Roberts

Khyati Roberts

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

Samantha Roberts

Genentech, A Member of the Roche Group, United States
Director, US Regulatory Policy
avatar for Scott Roberts

Scott Roberts

Citrus Health Group
Managing Partner
avatar for Andrew Robertson

Andrew Robertson

Global Head of Strategy, and Business Transformation, Digital and...
avatar for Kelly Robinson

Kelly Robinson

Health Canada
Director, Centre for Evaluation of Radiopharmaceuticals and...
avatar for Mitra Rocca

Mitra Rocca

FDA, United States
Associate Director, Medical Informatics, Office of Translational...
avatar for Lisa Rodriguez

Lisa Rodriguez

Lead Mathematical Statistician, OB, OTS, CDER
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Officer, Clinical Research Methodology, Reg Compliance & Medical...
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

The Reagan-Udall Foundation For the FDA
Scientific Director, IMEDS
avatar for Jameson Rogers

Jameson Rogers

Product Manager
avatar for Michelle Rohrer

Michelle Rohrer

Roche Genentech
Senior Vice President, Global Head of Product Development Regulatory...
avatar for Luis Rojas

Luis Rojas

Senior Principal Statistician

Kelly Roland

Otsuka Pharmaceutical Development and Commercialization
Associate Director
avatar for Heather Romero

Heather Romero

WCG – Analgesic Solutions
Clinical Scientist

Kevin Ronneberg

Health Partners
Vice President and Medical Director, Health Initiatives
avatar for Salvatore La Rosa

Salvatore La Rosa

Children's Tumor Foundation
Chief Scientific Officer

Elke Roschmann

IQVIA R&D Solutions Gmbh
Senior Director
avatar for Fran Ross

Fran Ross

Advanced Clinical
Practice Director, Trial Master File
avatar for Rosamund Round

Rosamund Round

Vice President, Patient Innovation Center
avatar for Doris Rouse

Doris Rouse

RTI International
Vice President, Global Health Technologies
avatar for Karen Roy

Karen Roy

Phlexglobal, United Kingdom
Chief Strategy Officer

Annalisa Rubino

Director of Epidemiology

Thorsten Ruppert

vfa - German Association of Research-Based Pharmaceutical Companies
Senior Manager Research/Development/Innovation
avatar for Pierre Sabourin

Pierre Sabourin

Health Canada, Canada
Assistant Deputy Minister, Health Products and Food Branch
avatar for Leonard Sacks

Leonard Sacks

FDA, United States
Associate Director for Clinical Methodology, Office of Medical...
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

European Medicines Agency, Netherlands
Head of Division International Affairs

Ken Sakushima

Pharmaceuticals and Medical Devices Agency (PMDA)
Medical Reviewer, Office of Advanced Evaluation with Electronic Data
avatar for Dennis Salotti

Dennis Salotti

The Avoca Group
Chief Operating Officer
avatar for Rachana Salvi

Rachana Salvi

Seth GS Medical College & KEM Hospital
Post Graduate Student
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Commercial Regulatory Affairs
avatar for Junko Sato

Junko Sato

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of International Programs

Sadiq Ali Sayed

National Pirogov Memorial Medical University, Vinnytsya
Medical Student
avatar for Elizabeth Scanlan

Elizabeth Scanlan

European Medicines Agency, Netherlands
Scientific Communication Officer, Stakeholders and Communication...
avatar for Vernon Schabert

Vernon Schabert

avatar for Deborah Schachter

Deborah Schachter

Janssen Research & Development, LLC
Scientific Director, Dossier Development & Operations, Small...
avatar for Monika Schneider

Monika Schneider

Duke-Margolis Center For Health Policy
Managing Associate
avatar for Philip Schneider

Philip Schneider

Alliance for Safe Biologic Medicines, United States
Chair, Advisory Board
avatar for Karlin Schroeder

Karlin Schroeder

Parkinson's Foundation, United States
Associate Vice President, Community Engagement
avatar for Tjerk Jan Schuitmaker

Tjerk Jan Schuitmaker

Athena Institute of the Vrije University of Amsterdam
IMI-PARADIGM; Assistant Professor
avatar for John Scott

John Scott

Director, Division of Biostatistics, OBE, CBER
avatar for Lisa Scott

Lisa Scott

Founder, Chief Executive Officer
avatar for Earl Seltzer

Earl Seltzer

Labcorp Drug Development, United States
Senior Director, Feasibility and Site Selection
avatar for Gaurav Shah

Gaurav Shah

APCER Life Sciences
Vice President and Head, Global Quality and Compliance

Anjali Sharma

Bristol-Myers Squibb
Sr Director, Business Capabilities and Innovation, Worldwide Patient...
avatar for Khushboo Sharma

Khushboo Sharma

Deputy Director for Operations, Office of New Drugs, CDER
avatar for T.J. Sharpe

T.J. Sharpe

Starfish Harbor LLC
Patient Advocate

Meiyu Shen

Expert Mathematical Statistician, Office of Translational Sciences,...
avatar for Rachel Sheppard

Rachel Sheppard

University of Louisville
Clinical Regulatory Director, Clinical Trials Unit (CTU)
avatar for Vladimir Shnaydman

Vladimir Shnaydman

ORBee Consulting, United States
avatar for Steve Sibley

Steve Sibley

Certara Synchrogenix, United States
Vice President, Global Submissions and Submission Leadership
avatar for Romi Singh

Romi Singh

Pfizer Inc
Head, Regional Regulatory (Innovative) Asia Pacific
avatar for Lindsay Singler

Lindsay Singler

Duke Clinical Research Institute
Associate Director, Research Communications and Engagement

Alison Skrinar

Ultragenyx Pharmaceutical
Vice President, Clinical Outcomes Research and Evaluation
avatar for Mary Ann Slack

Mary Ann Slack

FDA, United States
Director, Office of Strategic Programs, CDER
avatar for Nancy Slater

Nancy Slater

AbbVie, Inc., United States
Senior Director, Portfolio Program Management Therapeutic Area Head

Derek Van Slyke

Clinical Leader
Director of Strategic Partnerships
avatar for Nancy Smerkanich

Nancy Smerkanich

University of Southern California School of Pharmacy, United States
Assistant Professor Regulatory & Quality Sciences
avatar for Cameron Smith

Cameron Smith

Senior Chemist, OLDP, OPQ, CDER
avatar for Jeffrey Smith

Jeffrey Smith

Wave Life Sciences
Senior Director, Head, Patient Advocacy
avatar for Meredith Smith

Meredith Smith

Alexion Pharmaceuticals, United States
Director, Risk Management, Global Drug Safety, Research and...
avatar for Timothy Smith

Timothy Smith

Studymetrix Research, LLC
President and Chief Executive Officer
avatar for Patroula Smpokou

Patroula Smpokou

Deputy Director, Office of New Drugs, CDER
avatar for Donna Snyder

Donna Snyder

Senior Pediatric Ethicist and Team Leader, Office of Pediatric...
avatar for Kevin Snyder

Kevin Snyder

Pharmacologist, CDER/OND
avatar for Rachel Sobel

Rachel Sobel

Vice President, Epidemiology and Strategic Engagement

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