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avatar for Cris McDavid

Cris McDavid

Parexel International, United States
Senior Director, GCDO
GM

Gary McGeorge

Bristol Myers Squibb, United States
Director for PAT
avatar for Brittany McKelvey

Brittany McKelvey

LUNGevity Foundation, United States
Senior Director, Regulatory Policy
avatar for Lindsay McNair

Lindsay McNair

Equipoise Consulting, United States
Principal Consultant
avatar for Sean McNiff

Sean McNiff

Vertex Pharmaceuticals, Inc, United States
Director, Regulatory Operations
avatar for Cynthia McShea

Cynthia McShea

UCB Biosciences, United States
Head, Safety Statistics
avatar for Rachel Mead

Rachel Mead

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Senior GCP Inspector
avatar for Beth Meagher

Beth Meagher

Deloitte Consulting, United States
Principal
avatar for Christine Mears

Christine Mears

Generate BioMedicines, United States
Executive Director, Portfolio Management
avatar for Christine Mears

Christine Mears

Premiere Consulting Services LLC, United States
Founder, Lead Consultant
avatar for Christine Mears

Christine Mears

Generate BioMedicines, United States
Executive Director, Portfolio Management
MM

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany
AM

Aleksandr Merenkov

Genmab US, Inc., United States
Associate Director, Global Regulatory Intelligence
avatar for Danielle Metzger

Danielle Metzger

Network Partners Group, United States
Associate Director, Quality
AM

Anne-Marie Meyer

Lind AI, Switzerland
Advisor
avatar for Anton Mihic

Anton Mihic

McKinsey & Company, United States
Partner
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
avatar for Alexis Miller

Alexis Miller

MSD, United States
Head, Global Regulatory Policy
avatar for Jennifer Miller

Jennifer Miller

Yale School of Medicine, United States
Associate Professor of Medicine; Co-Director, Program for Biomedical...
avatar for Kristen Miller

Kristen Miller

FDA, United States
Health Scientist Policy Analyst, Office of Medical Policy, CDER
DM

Derick Mitchell

The Synergist/Pfmd, Ireland
Executive Director PFMD
MM

Michael Mittelman

American Living Organ Donor Fund, United States
Chairman
avatar for Yuki Miyatake

Yuki Miyatake

Eli Lilly and Company, Japan
Sr Group Manager
avatar for May Mo

May Mo

Amgen, United States
Associate Vice President, Biostatistics
AM

Ahmed Mohamed

Pharmacy and Poisons Board, Kenya
Chief Executive Officer
avatar for Carol Morales

Carol Morales

Astellas, United States
Lead, Quality Management and Capabilities
DM

Diana Morgenstern

Viatris, United States
Head, Real World Evidence and Outcomes Research
avatar for Orla Moriarty

Orla Moriarty

European Medicines Agency, Netherlands
Scientific Officer
KM

Kristy Morizio

Network Partners Group, United States
Senior Quality Consultant
ES

Elizabeth Smith Morris

Suvoda, United States
Director, Product Management, Patient Engagement
avatar for Patricia Mouta

Patricia Mouta

Biomanguinhos/Fiocruz, Brazil
Pharmacovigilance specialist
PM

Pralay Mukhopadhyay

GSK, United States
Vice President, Medicines Development Leader, Oncology R&D
avatar for Erin Mulrooney

Erin Mulrooney

Daiichi Sankyo Co., Ltd., United States
Director, Portfolio Analysis & Management
MM

Mallika Mundkur

FDA, United States
Deputy Chief Medical Officer, OC
avatar for Monica Munoz

Monica Munoz

FDA, United States
Division Director, Division of Pharmacovigilance-I, OSE, CDER
avatar for Namareq Musa

Namareq Musa

Pfizer, United States
Post-Doctoral Fellow
avatar for Jane Myles

Jane Myles

Digital Trials and Research Alliance, United States
VP, Programs and Initiatives
avatar for Sridevi Nagarajan

Sridevi Nagarajan

Ayusarogya, United Kingdom
DIA Communities Chair for AI in Healthcare
avatar for Reiko Nakashima

Reiko Nakashima

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of New Drug III
avatar for Kannan Natarajan

Kannan Natarajan

Pfizer, Inc., United States
Senior Vice President, Head of Global Biometrics and Data Management
avatar for Carolina Navas

Carolina Navas

IQVIA, Spain
COA Manager
avatar for Rebecca Nebel

Rebecca Nebel

Phrma, United States
Deputy Vice President, Science and Regulatory Advocacy
avatar for Rebecca Nebel

Rebecca Nebel

Amgen, United States
Director, Global Regulatory Policy and Intelligence
avatar for Rebecca Nebel

Rebecca Nebel

Phrma, United States
Deputy Vice President, Science and Regulatory Advocacy
SN

Shaoqing Ni

Children's Hospital Zhejiang University School of Medicine, China
Attending Pharmacist , Director
avatar for Inger Nielsen

Inger Nielsen

Novo Nordisk A/S, Denmark
Associate Director
avatar for Carrie Nielson

Carrie Nielson

Gilead Sciences, United States
Director of Epidemiology
EN

Emily Nieves

Delineate, United States
CEO/ Co-Founder
avatar for Brittany Niland

Brittany Niland

Eli Lilly and Company, United States
Senior Director- Patient Engagement, Recruitment, Diversity &...
avatar for Tushar Nitave

Tushar Nitave

Vivpro Corp, United States
Staff Software Engineer
avatar for Niklas Noren

Niklas Noren

Uppsala Monitoring Centre, Sweden
Chief Science Officer
JN

Jonathan Norman

YPrime Inc., United Kingdom
Director, Localization & Scale Management
TN

Tomoharu Numanyu

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Reviewer, Office of New Drug I
IN

Isaac Nyarko

Merz Aesthetics, United States
Senior Manager, Regulatory Affairs, Advertising and Promotion
TO

Thomas O'Connor

GSK, United States
Director Process Analytics
IO

Izumi Oba

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspection Deupty Director
avatar for Laura Okpala

Laura Okpala

Gilead Sciences, United States
Executive Director, Head of US Reimbursement Policy
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

ANVISA, Brazil
Deputy Head, Clinical Trials Office
avatar for Mayra Oliveira

Mayra Oliveira

Instituto Butantan, Brazil
pharmacovigilance manager
avatar for Jill Orosz

Jill Orosz

Bayer, United States
Vice President, TKI Franchise Head
avatar for Mary Ost

Mary Ost

Johnson & Johnson , United States
Director, AI-assisted Operations, Regulatory Medical Writing
avatar for Miki Ota

Miki Ota

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of Informatic and Manegement for Safety
avatar for Feisal Othman

Feisal Othman

Bristol Myers Squibb, United States
Benefit Risk Assessment Lead
avatar for Chelsea O'Connell

Chelsea O'Connell

Amgen, United States
Director, Global Regulatory Policy & Intelligence
JO

Joann O'Connor

GSK, United States
Executive Director, Head of Pipeline Project Management for BD and...
avatar for Liam O'Leary

Liam O'Leary

Certara, United States
Client Solutions Architect
avatar for Satchell Mede Pacheco

Satchell Mede Pacheco

Rutgers Univerity, United States
Medical Affairs Strategy Fellow
VP

Vihanga Pahalawatta

AbbVie, United States
Director Regulatory Affairs
avatar for Jeffery Painter

Jeffery Painter

GlaxoSmithKline, United States
Senior Director, Quantitative Leader for Safety Innovation &...
MP

Magdalena Pajewska

Office For Registration of Medicinal Products, Medical Devices and Biocides, Poland
Head of the International Relations Unit
avatar for Gerald Dal Pan

Gerald Dal Pan

FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
CP

Clare Paoletta

US House Committee on Energy and Commerce, United States
Professional Staff Member
avatar for Todd Paporello

Todd Paporello

Sanofi, United States
Vice President, Global Head of Regulatory Affairs, Specialty Care
avatar for Jimita Parekh

Jimita Parekh

Independent, United States
Managing Director
JP

Joann Parker

Pfizer, United States
Vice President of Regulatory CMC
avatar for Valerie Parker

Valerie Parker

Duke-Margolis Institute For Health Policy, United States
Assistant Research Director
AP

Alpa Patel

American Cancer Society, United States
Senior Vice President, Population Science
AP

Amit Patel

Octozi, United States
CEO
RP

Rakesh Patel

Neighborhood Healthcare (FQHC), United States
CEO
avatar for Sahishnu Patel

Sahishnu Patel

Synterex, United States
Associate Director, AI and Automation R&D
SP

Shital Patel

UCB, United States
Associate Safety Lead
SP

Shital Patel

UCB Biosciences, United States
Associate Safety Lead
SP

Shreena Patel

Massachusetts General Hospital, United States
Student Researcher
DP

Devin Peipert

University of Birmingham, United Kingdom
Professor of Health Outcomes Measurement
avatar for Michael Pelosi

Michael Pelosi

Astellas, United States
Lead, Quality Assurance, Analytics
avatar for Vada Perkins

Vada Perkins

Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
JP

Jami Peters

Gilead Sciences, United States
Associate Director
DP

David Pfeiffer

Acrisure Re, United States
SVP, Head of ARCAS, Bio-Tech
avatar for Jenni Pickett

Jenni Pickett

Yseop, United States
avatar for Beth MacEntee Pileggi

Beth MacEntee Pileggi

Johnson & Johnson, United States
Senior Director, Head of Safety Information Management and Automation
avatar for Luis Pinheiro

Luis Pinheiro

European Medicines Agency, Netherlands
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
PP

Purvi Prajapati

Eli Lilly, United States
Sr. Advisor
avatar for Regina Lynn Preciado

Regina Lynn Preciado

Content Rules, Inc., United States
VP, Content Strategy Solutions
RP

Ranjini Prithviraj

Regeneron Pharmaceuticals, United States
Director, Global Medical Affairs, Publication Management
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
CEO
avatar for Nina Dwi Putri

Nina Dwi Putri

Clinical Research Unit Cipto Mangunkusumo Hospital, Indonesia
Head of Sub-Unit Clinical Research Implementation
avatar for Su Qiu

Su Qiu

Beone Medicines, China
Director, Head of Medical Translation
AR

Angela Radcliff

Bristol Myers Squibb, United States
Lead, Research and Early Development, Digital Performance
AR

Allison Radwick

U.S. Pharmacopeia, United States
Senior Regulatory and Policy Communications Manager
avatar for Christine Von Raesfeld

Christine Von Raesfeld

The Light Collective, United States
Board member/community liaison
RS

Rajeev Singh Raghuvanshi

Central Drugs Standard Control Organization, India
Drug Controller General
avatar for Motiur Rahman

Motiur Rahman

FDA, United States
Senior Epidemiologist & Policy Advisor, Real World Evidence...
avatar for Mohit Raizada

Mohit Raizada

IQVIA, India
Director - Signal Management Services
avatar for Alex Raju

Alex Raju

Chatmedsafe | MS Candidate, LIU, United States
Founder & Lead Researcher
avatar for Mahesh Ramanadham

Mahesh Ramanadham

FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ,...
KR

Kathleen Rand

Procter & Gamble, United States
Principal Scientist
avatar for Prasanna Rao

Prasanna Rao

Saama, United States
Chief Products and Innovation Officer
RR

Ralf Raschke

McKinsey & Company, United States
Senior Expert
avatar for Jayanthi Reddy

Jayanthi Reddy

Head of Project and Portfolio Management, United States
Eikon Therapeutics
avatar for Stacey Ricci

Stacey Ricci

FDA, United States
Director, Scientific Review Staff, OTBB, CDER
avatar for Peter Richardson

Peter Richardson

European Medicines Agency, Netherlands
Senior Quality Specialist
avatar for Lia Ridout

Lia Ridout

-, United States
Patient Advocate
avatar for Isha Riley

Isha Riley

Regeneron, United States
Associate Director, Pharmacoepidemiololgy & Risk Management...
avatar for Gerd Rippin

Gerd Rippin

IQVIA, Germany
Senior Director, Biostatistics, Real-World Solutions
avatar for Donna Rivera

Donna Rivera

Canal Row Advisors, United States
Executive Vice President-Clinical Evidence Modernization
avatar for Amanda Roache

Amanda Roache

PhRMA, United States
Deputy Vice President, Science and Regulatory Advocacy
avatar for Jay Roberts

Jay Roberts

Ventac Partners, United States
Partner
avatar for Samantha Roberts

Samantha Roberts

AstraZeneca, United States
Senior Director, Regulatory Intelligence
avatar for Andrew Robertson

Andrew Robertson

Takeda, United States
Vice President, Head of Global Regulatory Policy and Innovation
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Bayer, United States
Director, Regulatory Affairs Policy and Science
avatar for Patrick Rodriguez

Patrick Rodriguez

Duke-Margolis Institute For Health Policy, United States
Policy Analyst
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Reagan-Udall Foundation for the FDA, United States
Director of Research
avatar for Michelle Rohrer

Michelle Rohrer

Genentech, A Member of the Roche Group, United States
Senior Vice President, Global Head of Product Development Regulatory...
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

Novo Nordisk Inc., United States
VP & Head, RQC, Science, Policy & Intelligence (SPI)
AR

Anuradha Roy

One Vector, United States
Senior Vice President
GR

Gargi Roy

Servier Canada, Canada
Regulatory Affairs Associate
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Pfizer, United States
Executive Director, Statistical Research and Innovation
LR

Leon Rozenblit

Q.E.D. Institute, United States
Executive Director
MR

Margaret Ruesch

Pfizer, United States
Vice President
KR

Katherin Ruiz

Eli Lilly and Company, United States
Consultant, Global Scientific Communications
avatar for Leo Russo

Leo Russo

Get Real Institute, United States
Advisor
MR

Mark Rutter

Formation Bio, United States
Vice President, Regulatory Affairs
AR

Angela Rylands

Kyowa Kirin, United Kingdom
Global Head of Patient Centred Outcomes
avatar for Fatima Sabar

Fatima Sabar

Bluenote Health, United States
CEO
HS

Haleh Saber

FDA, United States
Deputy Director, DHOT/ OHOP/ CDER
avatar for Budi Gunadi Sadikin

Budi Gunadi Sadikin

Ministry of Health, Indonesia
Minister
SS

Shabbir Safdar

Partnership for Safe Medicines, United States
Executive Director
avatar for Takahiro Sakai

Takahiro Sakai

National Cancer Center Hospital, Japan
Chief, Clinical Research Coordinating Section
avatar for Leslie Sam

Leslie Sam

Leslie Sam and Associates, LLC, United States
President
avatar for Meisha Sampson

Meisha Sampson

FDA, United States
Director
avatar for Greg Sarafin

Greg Sarafin

Sovereign AI, United States
Chief Administrative Officer
avatar for Surbhi Sarna

Surbhi Sarna

Collate, United States
CEO
avatar for Daniele Sartori

Daniele Sartori

Uppsala Monitoring Centre (UMC), Sweden
Senior Pharmacovigilance Scientist
avatar for Junko Sato

Junko Sato

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
avatar for Camille Sauder

Camille Sauder

Yseop, United States
PS

Peter Schaeffer

GlaxoSmithKline, United States
Digital and Process Optimization Leader
avatar for AlphaLife Sciences

AlphaLife Sciences

China
avatar for Nick Scott

Nick Scott

Biogen, United States
Head, Strategic Resourcing and Performance Optimization
avatar for Jenn Sellers

Jenn Sellers

FDA, United States
Chief, GCP Assessment Branch
avatar for Katherine Senter

Katherine Senter

Sidney Kimmel Cancer Center – Jefferson Health, United States
Assistant Director, Cancer Clinical Research Operations
avatar for Omar Serang

Omar Serang

DNAnexus, United States
Chief Cloud Officer
HS

Harsh Shah

Clinplex, United States
CoFounder and CEO
avatar for Ali Shamoun

Ali Shamoun

Regeneron, United States
Director, Global Development Systems
avatar for Raja Shankar

Raja Shankar

IQVIA, United Kingdom
VP, Machine Learning
avatar for T.J. Sharpe

T.J. Sharpe

Sharpe Patient Insights, United States
Patient Engagement Expert
avatar for Jennifer Sheller

Jennifer Sheller

Merck & Co., Inc., United States
Senior Vice President, Global Clinical Trial Operations
JS

Jennifer Shelton

Actalent, United States
Solution Executive
HS

Hui Shi

China Center for Food and Drug International Exchange, China
Director, Development Research Division
avatar for Molly Shields

Molly Shields

Duke-Margolis Institute For Health Policy, United States
Policy Analyst, Assistant
avatar for Ju-Young Shin

Ju-Young Shin

School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Professor
avatar for Sooyoon Shin

Sooyoon Shin

Verily Health, United States
Senior Manager
avatar for Ekaterina Shipilova

Ekaterina Shipilova

The Wistar Institute/The University of Bologna, United States
PhD Candidate
avatar for Steve Sibley

Steve Sibley

Veristat LLC, United States
Vice President, Global Submissions and Submissions Leadership
avatar for Steve Sibley

Steve Sibley

Certara, United States
Vice President, Global Submissions and Submissions Leadership
avatar for Alain Silk

Alain Silk

Tempus AI, Inc., United States
Senior Director, Regulatory Affairs
LS

Lauren Silvis

Tempus, United States
Senior Vice President, External Affairs
avatar for Sanj Singh

Sanj Singh

Temple Therapeutics, Netherlands
CEO
TS

Teginder Singh

Google, United States
Global Head Regulatory Quality Safety
MS

Megha Sinha

Kamet Consulting Group, United States
CEO
avatar for Ted Slater

Ted Slater

EPAM Systems, United States
Global Head, Knowledge Engineering & Data Advisory
MS

Maryna Slobodnichenko

Ministry of Health of Ukraine, Ukraine
Deputy Minister
JS

Jeff Smith

Smith and Jones Innovation, United States
The Curator
avatar for Meredith Yearsley Smith

Meredith Yearsley Smith

USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Fellow and faculty member
DS

Dan Sndyer

The Playbook, United States
DS

Dan Sndyer

The Playbook, United States
DP

Diogo Penha Soares

ANVISA, Brazil
Deputy Director
avatar for Mariana Socal

Mariana Socal

Johns Hopkins Bloomberg School of Public Health, United States
Associate Professor
avatar for Elizabeth Somers

Elizabeth Somers

Merck & Co., Inc., United States
Associate Vice President, Global Project and Alliance Management
avatar for Sophie Sommerer

Sophie Sommerer

Health Canada, Canada
Director General, Marketed Health Products Directorate
AS

Aissatou SOUGOU

Department of Pharmacy and Laboratories (DPL) , Senegal
Director General
MR

Maira Ribeiro de Souza

ANVISA, Brazil
Expert, Division of Safety and Efficacy Assessment
IS

Ioannis Spyroglou

MSD, United States
Associate Director, Data Science
avatar for Nicole Stansbury

Nicole Stansbury

Premier Research, United States
Senior Vice President Global Clinical Operations
JS

Jeff Steinke

TE Digital Limited, United Kingdom
Founder
AS

Alan Stevens

Abbvie, United States
Global Head, Complex Devices and Drug Delivery Systems
avatar for Gloria Stone

Gloria Stone

G. Stone Connections, L.L.C., United States
Owner
avatar for Walter Straus

Walter Straus

Moderna, United States
Vice President, Safety and PV
avatar for Andrew Studna

Andrew Studna

Applied Clinical Trials, United States
Senior Editor
avatar for Ling Su

Ling Su

Yeehong Business School, China
Research Fellow
avatar for Ayoub Suliman

Ayoub Suliman

FDA, United States
Regulatory Health Project Manager
SS

Sean Sullivan

University of Washington, United States
Prof. of Pharmacy, Public Hlth
MS

Mumtaz Sultani

European Medicines Agency, Netherlands
avatar for John Sun

John Sun

Novartis, United States
Program Lead, Portfolio, Strategy & Operations, CRM DU,...
avatar for Indri Supriadi

Indri Supriadi

Indonesia Ministry of Health (MOH), Indonesia
Head of BB Binomika (Parent Organization of INA-CRC)
KS

Katherine Szarama

FDA, United States
Deputy Director, CBER
avatar for Lawrence Tallon

Lawrence Tallon

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Chief Executive Officer
avatar for Nancy Tam

Nancy Tam

Pfizer, United States
Vice President and Head of Medical Writing
avatar for Masaya Tamae

Masaya Tamae

Meiji Seika Pharma., Co., Ltd, Japan
Deputy General Manager, Corporate Strategy Division
avatar for Cecilia Tami

Cecilia Tami

Genentech, A Member of the Roche Group, United States
Head US CMC Regulatory Policy
avatar for Cecilia Tami

Cecilia Tami

Genentech, United States
Head US CMC Regulatory Policy
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