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avatar for Alison Maloney

Alison Maloney

Bayer , United States
Head of Regulatory Affairs North America
avatar for Lesley Maloney

Lesley Maloney

Genentech, A Member of the Roche Group, United States
Regulatory Policy Lead
avatar for Raghav Mani

Raghav Mani

NVIDIA, United States
Director of Digital Health Products,
avatar for Raghav Mani

Raghav Mani

NVIDIA, United States
Director of Digital Health Products
avatar for Shweta Maniar

Shweta Maniar

Google Cloud, United States
Director, Healthcare and Life Sciences Solutions
SM

Stephanie Manson

IND Directions, LLC, United States
VM

Valentina Mantua

FDA, United States
Associate Director of Regulatory Science, OND, CDER
avatar for Anabela Marcal

Anabela Marcal

European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
avatar for Kwaku Marfo

Kwaku Marfo

IQVIA, Ghana
Africa Market Development Specialist
SM

Segundo Mariz

European Medicines Agency, Netherlands
JM

Joseph Markmann

Johnson&Johnson, United States
Principal Data Science Lead, Global Regulatory Affairs
avatar for Ingrid Markovic

Ingrid Markovic

United States
avatar for Kristi Martin

Kristi Martin

Camber Collective, United States
Director
avatar for Sarah Martin

Sarah Martin

Eli Lilly & Co., United States
Senior Director - Global Regulatory Policy (Oncology)
GM

Grace Matimba

Medicines Control Authority of Zimbabwe, Zimbabwe
Chief Regulatory Officer
avatar for Maria Mavris

Maria Mavris

European Medicines Agency, Netherlands
Patient Relations
avatar for Jennifer McCafferty

Jennifer McCafferty

Merck, United States
Senior Vice President, Regulatory CMC and Quality Assurance
avatar for Laura Mccary-Bloss

Laura Mccary-Bloss

Amgen, Inc., United States
Vice President Global Regulatory Affairs
avatar for Lorie McClain

Lorie McClain

Salesforce, United States
Distinguished, Strategic Solution Engineer
avatar for Neil McCullough

Neil McCullough

IQVIA, United States
Executive Vice President, Clinical Quality and Compliance
avatar for Michael McDonald

Michael McDonald

Health Products Regulatory Authority, Ireland
Programme Manager, Office of the Chief Executive
avatar for Niamh McGuinness

Niamh McGuinness

IQVIA, United States
Director, Pharma Solutions, IQVIA Applied AI Science
avatar for Mark McKenzie

Mark McKenzie

EmVenio Research, United States
Chief Medical Officer
AM

Amanda McMannis

The Prostate Cancer Clinical Trials Consortium, United States
Associate Director, Clinical Operations
avatar for Lindsay McNair

Lindsay McNair

Equipoise Consulting, United States
Principal Consultant
avatar for Melodi McNeil

Melodi McNeil

AbbVie, United States
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early...
avatar for Carly McWilliams, MBA

Carly McWilliams, MBA

Roche Diagnostics, United States
Head of Regulatory Policy
DM

Denise Meade

Verily, United States
Vice President, Life Sciences and MedTech
avatar for Christine Mears

Christine Mears

Generate BioMedicines, United States
Executive Director, Portfolio Management
avatar for David Meats

David Meats

Certara, United States
Director, Regulatory Services & Medical Affairs Management
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

FDA, United States
Director, Office of Clinical Policy
avatar for Doug Melton

Doug Melton

Vertex, United States
Distinguished Research Fellow
avatar for Angela Men

Angela Men

The Whiteoak Group, Inc, United States
Chief Executive Officer
avatar for Timothe Menard

Timothe Menard

F. Hoffmann-La Roche Ltd, Switzerland
Global Head, Quality Excellence Digital | Bioethics Coach (Data...
avatar for Amber Meriwether

Amber Meriwether

Astellas Pharma, United States
Corporate Strategy
avatar for Todd Mersch

Todd Mersch

Microsoft, United States
Consulting Leader
avatar for Anton Mihic

Anton Mihic

McKinsey & Company, United States
Partner
avatar for Alexis Miller

Alexis Miller

Merck & Co., Inc., United States
Head, Global Regulatory Policy and Intelligence
avatar for Bruce Miller

Bruce Miller

COPD Foundation, United States
Chief Scientific Officer
avatar for Yuki Miyatake

Yuki Miyatake

Eli Lilly Japan, Japan
Sr Manager
DM

David Moeny

FDA, United States
Acting Deputy Director, Office of Pharmacovigilance and Epidemiology,...
avatar for Korrey Monroe

Korrey Monroe

North Carolina Community Health Center Association, United States
Program Manager
avatar for Carol Morales

Carol Morales

Astellas, United States
Lead, Quality Management and Capabilities
avatar for Greg Morehouse

Greg Morehouse

Abbvie, United States
Senior Manager, RA Device, Combination Products
avatar for Marcelo Moreira

Marcelo Moreira

ANVISA, Brazil
GENERAL MANAGER
avatar for Ben Moscovitch

Ben Moscovitch

Amazon Web Services, United States
Public Policy
avatar for Taraneh Mousavi

Taraneh Mousavi

University of Maryland, Baltimore, United States
PhD Student
avatar for Florence Mowlem

Florence Mowlem

Umotif, United Kingdom
Chief Scientific Officer
avatar for Katie Moy

Katie Moy

Acadia Pharmaceuticals, United States
Associate Director, Medical Information & Review
avatar for David Mukanga

David Mukanga

Bill & Melinda Gates Foundation, United States
Deputy Director, Africa Regulatory Systems
avatar for Saurabh Mukhopadhyay

Saurabh Mukhopadhyay

Abbvie, United States
Research Fellow, Statistical Innovations
avatar for Theresa Mullin

Theresa Mullin

FDA, United States
Associate Center Director - CDER
avatar for Erin Mulrooney

Erin Mulrooney

Daiichi Sankyo, Inc, United States
Director, Portfolio Management
AM

Alissa Mun

FDA, United States
Health Scientist Policy Analyst, OMP, CDER
GM

Greeshma Mundayat

Maxisit, United States
Solution Owner
avatar for Monica Munoz

Monica Munoz

FDA, United States
Division Director, Division of Pharmacovigilance-I, OSE, CDER
avatar for Ryan Murphy

Ryan Murphy

ICON, United States
Associate Outcomes Researcher
avatar for Lindsey Murray

Lindsey Murray

Critical Path Institute, United States
Executive Director, Rare Disease COA Consortium
avatar for Kiran Musunuru

Kiran Musunuru

University of Pennsylvania, United States
Professor of Medicine
avatar for Nancy Myers

Nancy Myers

Catalyst Healthcare Consulting, United States
CEO and Founder
avatar for Jane Myles

Jane Myles

Decentralized Trials and Research Alliance, United States
Program Director
avatar for Joseph Nadglowski

Joseph Nadglowski

Obesity Action Coalition, United States
President/Chief Executive Officer
avatar for Sridevi Nagarajan

Sridevi Nagarajan

Ayusarogya, United Kingdom
DIA Communities Lead for AI in Healthcare
avatar for Meera Nagaria

Meera Nagaria

Johnson & Johnson, United States
Senior Data Scientist
avatar for Narayan Nair

Narayan Nair

FDA, United States
Associate Director Regulatory Affairs, Office of Biostatistics and...
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Medidata Solutions, United States
Senior Director
avatar for Kenichi Nakamura

Kenichi Nakamura

National Cancer Center Hospital, Japan
Chief, Department of International Clinical Development
avatar for Sumati Nambiar

Sumati Nambiar

Johnson and Johnson, United States
Senior Director
avatar for Rohit Nambisan

Rohit Nambisan

Lokavant, Inc., United States
CEO
avatar for SRIVIDYA NARAYANAN

SRIVIDYA NARAYANAN

Northeastern University, United States
Student
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

IPM, United States
Senior Consultant
avatar for Wassim Nashabeh

Wassim Nashabeh

Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Technical Regulatory Policy &...
avatar for Adil Nashed

Adil Nashed

Health Canada, Canada
Drug Specialist
avatar for Sharmin Nasrullah

Sharmin Nasrullah

Salesforce, United States
General Manager, Life Sciences, Clinical
avatar for Aliza Nathoo

Aliza Nathoo

F. Hoffmann-La Roche Ltd., Canada
Senior Director, Content Strategy
avatar for Nancy Ngum

Nancy Ngum

AUDA-NEPAD, South Africa
Public Health Officer
avatar for Christiane Niederlaender

Christiane Niederlaender

Parexel International, United Kingdom
Vice President, Technical
NN

Nikolay Nikolov

FDA, United States
Director, Office of Immunology and Inflammation, OND, CDER
avatar for Brittany Niland

Brittany Niland

Eli Lilly and Company, United States
Senior Director-Clinical Trials Foundation Community Based Research
avatar for Shinichi Noda

Shinichi Noda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division Director, Division of Planning and Management, Office of...
avatar for Francisco Nogueira

Francisco Nogueira

Accumulus Synergy, United States
Chief Executive Officer
RN

Rebecca Noss

Noss Research Consulting, United States
President, Global Pharmacovigilance Consultant
avatar for Perla Nunes

Perla Nunes

Community Outreach and Clinical Research DEI Thought Leader, United States
Patient Advocate
avatar for Jude Nwokike

Jude Nwokike

USP, United States
Vice President, Global Health & Manufacturing Services
BO

Brendan O'Leary

United States
Consultant
avatar for Teresa Oblak

Teresa Oblak

Fortrea, United States
Senior Director, Regulatory Strategy
SO

Sean Ogle

SEI Inc., United States
Senior Consultant
avatar for Miyako Okayama

Miyako Okayama

Otsuka Pharmaceutical, Co., Ltd., Japan
Regulatory Expert, Regulatory Technology & Operations Office,...
avatar for Evon Okidi

Evon Okidi

Medidata Solutions, A Dassault Systemes Company, United States
Senior Data Scientist
avatar for Ebere Okpara

Ebere Okpara

University of Illinois Chicago, United States
PhD Candidate
avatar for Jimi Olaghere

Jimi Olaghere

United States
Patient Advocate
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

ANVISA, Brazil
Health Regulation Expert
SO

Susan Oliveria

Thermo Fisher Scientific, United States
Vice President, Global Head of Epidemiology and Scientific Affairs...
avatar for Rosemary Orciari

Rosemary Orciari

Pfizer, United States
Senior Director, Reg Intel, Policy and QMS Lead
AO

Anna Osinski

Biogen, Inc., United States
Associate Director, Development Unit Lead, Patient Centricity and...
avatar for Manuel Osorio

Manuel Osorio

FDA, United States
Senior Scientist for Emerging Technologies, OD, CBER
avatar for Feisal Othman

Feisal Othman

Bristol Myers Squibb, United States
Benefit Risk Assessment Lead
avatar for Mercy Owusu-Asante

Mercy Owusu-Asante

University of Hertfordshire, United Kingdom
Graduate Student, School of Life and Medical Sciences
avatar for Chelsea O'Connell

Chelsea O'Connell

Amgen, United States
Director, Global Regulatory Policy & Intelligence
avatar for Catina O'Leary

Catina O'Leary

Health Literacy Media, United States
President and Chief Executive Officer
avatar for William Palo

William Palo

AbbVie, United States
Director, Safety Statistics
RP

Renata Parca

ANVISA, Brazil
Health regulatory specialist
avatar for Sudip Parikh

Sudip Parikh

United States
Chief Executive Officer and Executive Publisher, Science Journals
SP

Sohyeon Park

KIDS, Korea, Republic of
pharmacist
avatar for Valerie Parker

Valerie Parker

Duke-Margolis Institute For Health Policy, United States
Assistant Research Director
avatar for Jaymin Patel

Jaymin Patel

AESARA, United States
HEOR
MP

Mayur Patel

AstraZeneca, United States
Vice President, Oncology Therapy Area, Global Patient Safety
EP

Elisabetta Patorno

Brigham and Women's Hospital; Harvard Medical School, United States
Associate Professor of Medicine
avatar for Julie Patterson

Julie Patterson

National Pharmaceutical Council, United States
Senior Director of Research
avatar for Richard Pazdur

Richard Pazdur

FDA, United States
Director, Oncology Center of Excellence, CDER
avatar for Y. Veronica Pei

Y. Veronica Pei

FDA, United States
Acting Associate Director, Biomedical Informatics and Regulatory...
avatar for Michael Pelosi

Michael Pelosi

Astellas, United States
Director, Quality Analytics
avatar for Ruonan Peng

Ruonan Peng

University of California, Riverside, United States
Graduate Research Assistant
DP

Daniel Pereira

ANVISA, Brazil
avatar for Raphael Sanches Pereira

Raphael Sanches Pereira

ANVISA, Brazil
General Manager of the Office for Medicines
avatar for Eleanor Perfetto

Eleanor Perfetto

Consultant, United States
Independent Consultant
avatar for Vada Perkins

Vada Perkins

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

Luciana Petcu

Takeda, United States
Senior Manager
avatar for Maryrose Petrizzo

Maryrose Petrizzo

Clinical Quality Assured,LLC, United States
President and Consultant
avatar for Yen Phan

Yen Phan

University of Oxford, Ireland
Student
avatar for Carie Pierce

Carie Pierce

DIA, United States
Global Head of Growth & Business Development
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

AbbVie, United States
Head, Regulatory Policy for Emerging Markets -Japan and Australia
avatar for Luis Pinheiro

Luis Pinheiro

European Medicines Agency, Netherlands
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
avatar for Neosho Ponder

Neosho Ponder

Tigerlily Foundation, United States
National A.N.G.E.L. Lead
avatar for Elena Popa

Elena Popa

Bayer, Switzerland
Chief of Staff, Global Regulatory Affairs
avatar for Caroline Pothet

Caroline Pothet

European Medicines Agency, Netherlands
Head of advanced therapies and haemato-oncology
avatar for James Pound

James Pound

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Group Manager - British Pharmacopoeia & Laboratory Services
avatar for Johann Proeve

Johann Proeve

Cyntegrity, Germany
Chief Scientific Officer
avatar for Stephen Pyke

Stephen Pyke

Parexel, United Kingdom
Chief Clinical Data and Digital Officer
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Alexion, United States
Vice President, Head of Regulatory Science and Execution
AR

Adriana Racolta

Pfizer Inc, United States
Director, Regulatory Affairs, Companion Diagnostics
avatar for Sophie Radicke

Sophie Radicke

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GPvP and Senior Pharmacovigilance Inspector
AR

Allison Radwick

U.S. Pharmacopeia, United States
Senior Regulatory and Policy Communications Manager
avatar for Mohit Raizada

Mohit Raizada

IQVIA, India
Director - Signal Management Services
avatar for Aysha Rana

Aysha Rana

Spectra Medical/Northeastern University, United States
Regulatory Affairs Specialist
DR

Diogo Rao

Eli Lilly, United States
Chief Information Officer
CR

Chantelle Rein-Smith

Whitsell Innovations, Inc., United States
Principal Medical Writer and Consultant
avatar for Matthew Renda

Matthew Renda

Alexion, Astrazeneca Rare Disease, United States
Senior Director Medical Writing Operations
avatar for Linda Reuter

Linda Reuter

BRANY IRB, United States
Senior Director
SR

Sarah Rhee

Alexion Pharmaceuticals, Inc, United States
Vice President, Head of Global Regulatory Affairs
avatar for Kim Ribeiro

Kim Ribeiro

Boehringer Ingelheim, United States
Director Patient Experience & Engagement
avatar for Brandon Rice

Brandon Rice

Weave Bio, United States
CPO
avatar for Katrina Rice

Katrina Rice

eClinical Solutions, United States
Chief Delivery Officer, Biometrics Services
avatar for Kevin Richards

Kevin Richards

AstraZeneca, Canada
Senior Director, Clinical Quality
avatar for Nicole Richie

Nicole Richie

Genentech, United States
Vice President & Global Head Health Equity & Population...
AC

Amy Comstock Rick

FDA, United States
Director of Strategic Coalitions, Rare Disease Innovation Hub
avatar for Lia Ridout

Lia Ridout

N/A, United States
Patient Advocate
avatar for Donna Rivera

Donna Rivera

FDA, United States
Associate Director for Pharmacoepidemiology, Oncology Center of...
avatar for Amanda Roache

Amanda Roache

PhRMA, United States
Deputy Vice President, Science and Regulatory Advocacy
SR

Sarah Roberge

WCG Clinical, United States
IBC Chair, IBC Services
avatar for Sajida Roberson

Sajida Roberson

Independent Consultant, United States
Business Transformation
avatar for Samantha Roberts

Samantha Roberts

AstraZeneca, United States
Senior Director, Regulatory Intelligence
avatar for Matthew Robillard

Matthew Robillard

AbbVie, United States
Senior Director, Regulatory Strategic Writing
avatar for Kelly Robinson

Kelly Robinson

Health Canada, Canada
Director General, Pharmaceutical Drugs Directorate
PR

Paulette Robinson

Neurogene Inc., United States
Senior Director, Regulatory Affairs
WR

Warren Roche

Sanofi, Ireland
Statistician
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 Ulrich Rohr

Ulrich Rohr

Swissmedic, Switzerland
Unit Head Clinical Review Hematology & Oncology
avatar for Maria Antonieta Roman

Maria Antonieta Roman

Novartis, Mexico
Head Regulatory Policy LaCan
avatar for Peter Ronco

Peter Ronco

Emmes, United States
CEO
avatar for Patricia Roselle

Patricia Roselle

Sanofi, United States
Head of Patient Stakeholder Engagement
avatar for Len Rosenberg

Len Rosenberg

Beat AML, a division of The Leukemia and Lymphoma Society, United States
Head of Clinical Operations
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Senior Director/ Head of US Regulatory Scientific Policy
avatar for David Ross

David Ross

AstraZeneca, United States
Senior Director, Regulatory Data and Submissions
avatar for Dawn Rotellini

Dawn Rotellini

National Bleeding Disorder Foundation, United States
Chief Operating Officer
avatar for Cynthia Rothblum-Oviatt

Cynthia Rothblum-Oviatt

FDA, United States
Science Policy Analyst, Rare Disease Team, OND, CDER
avatar for Mark Rothmann

Mark Rothmann

FDA, United States
Division Director, OTS, OB, CDER
avatar for Todd Rudo

Todd Rudo

Clario, United States
EVP, Chief Medical Officer
avatar for Lisa Ruiz

Lisa Ruiz

Abbvie, United States
VP, Regulatory Affairs Operations, CMC & Device
avatar for Andrea Russell

Andrea Russell

Northwestern University Feinberg School of Medicine, United States
Assistant Professor
PR

Patrick Ryan

Janssen Pharmaceuticals, Inc., United States
Vice President Observational Health Data Analytics
FS

Fatima Sabar

Bluenote AI, United States
President
AS

Arman Sabbaghi

Unlearn, United States
Head of Biostatistics Research
avatar for Arman Sabbaghi

Arman Sabbaghi

Purdue University, United States
Associate Professor of Statistics
avatar for Budi Gunadi Sadikin

Budi Gunadi Sadikin

Ministry of Health, Indonesia
Minister
avatar for Leslie Sam

Leslie Sam

Leslie Sam and Associates, LLC, United States
President
avatar for Toshiharu Sano

Toshiharu Sano

MSD, Japan
Associate Vice President
avatar for Dandara Santana

Dandara Santana

ANVISA, Brazil
CMC reviewer
avatar for Daniele Sartori

Daniele Sartori

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

Junko Sato

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
avatar for Patrick Saunders

Patrick Saunders

Eli Lilly & Co., United States
Senior Director-Quality, Lilly del Caribe
SS

Scott Schell

Cognizant, United States
Chief Medical Officer
avatar for Anja Schiel

Anja Schiel

Norwegian Medical Products Agency (noma), Norway
Special Advisor, Lead Methodologist/Statistician; NoMA
avatar for Chris Schneiderman

Chris Schneiderman

Abbvie, United States
Director, Data & Digital Convergence Catalyst
SS

Silke Schoch

National Health Council, United States
Director, Research & Programs
avatar for Eric Schrock

Eric Schrock

OM1, United States
Chief Technology Officer
avatar for Carrie Scott

Carrie Scott

AbbVie Ltd, Portugal
Head, Global PV Compliance and Policy, Pharmacovigilance and Patient...
avatar for Eri Sekine

Eri Sekine

CMIC Co., Ltd, Japan
Executive Vice President Data Business
RS

Rohini Sen

AbbVie, United States
Director, HEOR
avatar for Ana Sengupta

Ana Sengupta

Mirum Pharmaceuticals, Inc., United States
Director Regulatory Affairs CMC
avatar for Omar Serang

Omar Serang

DNAnexus, United States
Chief Cloud Officer
avatar for Imran Shah

Imran Shah

EMD Serono, United States
SVP & Head, Global Regulatory, R&D Quality and Safety (RQS)
avatar for Saad Shakir

Saad Shakir

ADROITVIGILANCE, United Kingdom
Pharmacovigilance Physician and Pharmacoepidemiologist
avatar for Saad Shakir

Saad Shakir

Drug Safety Research Unit, United Kingdom
Director
avatar for Raja Shankar

Raja Shankar

IQVIA, United Kingdom
Vice President, Machine Learning
avatar for Ana Sharma

Ana Sharma

Abivax, United States
Vice President, Global Head of Research and Development Quality...
JS

John Sharretts

FDA, United States
Director at Division of Diabetes, Lipid Disorders, and Obesity
AS

Anantha Shekhar

University of Pittsburgh, United States
Dean, School of Medicine
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