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Lara Lane

Ironwood Pharmaceuticals, United States
Director, Clinical Operations
avatar for Samantha Lane

Samantha Lane

Drug Safety Research Unit, United Kingdom
Head of Research, Centre of Pharmacovigilance Sciences
avatar for Connie Langer

Connie Langer

Pfizer Inc, United States
Senior Director
avatar for Juan Lara

Juan Lara

Centre For Innovation In Regulatory Science, Mexico
Senior Research Analyst
avatar for Joseph Laudano

Joseph Laudano

IQVIA, United States
Medical Director
avatar for Marion Laumonier

Marion Laumonier

World Health Organization (WHO), Switzerland
Technical Officer, Regulatory Convergence and Networks
avatar for Anthony Lawler

Anthony Lawler

Therapeutic Goods Administration, Australia
Deputy Secretary, Health Products Regulation Group
avatar for Cathryn Lee

Cathryn Lee

FDA, United States
Director, Office of Program Operations, PDIMS, OND, CDER
avatar for Charles Lee

Charles Lee

AstraZeneca, United States
Executive Regulatory Science Director
avatar for Jennifer Lee

Jennifer Lee

FDA, United States
Senior Health Scientist, Oncology Center of Excellence
avatar for Kerry Jo Lee

Kerry Jo Lee

FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare...
avatar for Mark Lee

Mark Lee

N-Power Medicine, United States
CEO
avatar for Sau Lee

Sau Lee

FDA, United States
Deputy Super Office Director, OPQ, CDER
HV

Hans van Leeuwen

Astellas Pharma Europe BV, Netherlands
Head of Regulatory Operations
ML

Michael Lehmicke

Alliance for Regenerative Medicine, United States
Senior Vice President, Science and Industry Affairs
avatar for Catherine Lerro

Catherine Lerro

FDA, United States
Senior Pharmacoepidemiologist, Oncology Center of Excellence
avatar for Anastasia Lesogor

Anastasia Lesogor

Novartis Pharma AG, Switzerland
Senior Global Program Clinical Program Head
avatar for Char Leung

Char Leung

Genmab, United States
Director, Development Program Management
avatar for Bennett Levitan

Bennett Levitan

Janssen Research & Development LLC, United States
Senior Director, Benefit-Risk Assessment, Global Epidemiology
avatar for Emily Lewis

Emily Lewis

UCB, United States
Artificial Intelligence and Innovation Lead, Neurology
LL

Lily Li

Metaverse Law, United States
Founder and President
avatar for Carsten Linnermann

Carsten Linnermann

Neogene Therapeutics, AstraZeneca Group, Netherlands
Chief Executive Officer
avatar for Craig Lipset

Craig Lipset

Clinical Innovation Partners, United States
Managing Partner
avatar for Ke Liu

Ke Liu

Marengo Therapeutics, United States
Chief Development Officer
avatar for Qi Liu

Qi Liu

FDA, United States
Assoc Director for Innovation and Partnerships, OCP, OTS, CDER
TJ

Tong (Jenny) Liu

US Pharmacopeia, United States
Principal Scientist
CL

Catherine Lockhart

Biologics and Biosimilars Collective Intelligence Consortium, United States
Chief Science Officer
avatar for Infosys Technologies Ltd.

Infosys Technologies Ltd.

United States
avatar for Shun Lu

Shun Lu

Shanghai Jiaotong University, China
Director, Center for Clinical Medicine of Lung Cancer, Shanghai Chest...
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
avatar for Tyler Ludlow

Tyler Ludlow

Decision Skills Institute, United States
Founder and Chief Decision Scientist
avatar for Yuan Luo

Yuan Luo

National Institute on Aging, NIH, United States
Program Director, AD/ADRD Biomarkers, Division of Neuroscience
avatar for Sarah Lyons

Sarah Lyons

IQVIA, Canada
Vice President, Data Transformation and AI Platforms, DTA and AI
avatar for Liyang Lyu

Liyang Lyu

University of Macau, Macao
Student
avatar for Rebecca Lyzinski

Rebecca Lyzinski

JMP Statistical Discovery, United States
Senior Software Developer
avatar for Gary Ma

Gary Ma

Taimei Technology Inc., United States
President
avatar for Tara MacCannell

Tara MacCannell

Vertex, United States
Global Head, RWE
avatar for Currien MacDonald

Currien MacDonald

WCG, United States
Medical Chair Director
avatar for Demetra Macheras

Demetra Macheras

AbbVie, United States
Director, Regulatory Policy and Intelligence - Regulatory Affairs
avatar for Christina Mack

Christina Mack

IQVIA, United States
Chief Scientific Officer, Real-World Solutions
avatar for Subha Madhavan

Subha Madhavan

Pfizer Inc, United States
Vice President and Head of AI/ML, Global Biometrics and Data...
avatar for Laura Magda

Laura Magda

SRI International, United States
Director of Clinical Trials
avatar for Nicole Mahoney

Nicole Mahoney

Novartis Pharmaceuticals Corporation, United States
Executive Director US Regulatory Policy & Intelligence
avatar for Kausik Maiti

Kausik Maiti

Parexel International , India
Executive Director, Safety Medical Sciences
avatar for Antara Majumdar

Antara Majumdar

GlaxoSmithKline, United States
Director, Oncology Statistics
JM

Jennifer Malinowski

Johnson & Johnson Innovative Medicine, United States
Director, Access and Policy Research
avatar for Subhro Mallik

Subhro Mallik

Infosys, United States
EVP - Global Head of Life Sciences
VM

Vandana Mandavilli

Northeastern University, United States
MS Regulatory Affairs Student
avatar for Sri Mantha

Sri Mantha

FDA, United States
Director, Office of Strategic Programs, CDER
AM

Angelika Manthripragada

Regeneron, United States
Director, Pharmacoepidemiology, Global Patient Safety
avatar for Anabela Marcal

Anabela Marcal

European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
avatar for Peter Marks

Peter Marks

FDA, United States
Director, Center for Biologics Evaluation and Research
AM

Andrew Marley

Parexel, Spain
Senior Epidemiologist
avatar for Allison Martin

Allison Martin

Sanofi, United States
Director, Regulatory Science and Policy, North America
avatar for Eddilisa Martin

Eddilisa Martin

M&B Sciences Inc., United States
Co-Founder and Chief Executive Officer
avatar for Hotaka Maruyama

Hotaka Maruyama

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division of PharmacoEpidemiology, Office of Pharmacovigilance ?
avatar for Rosana Mastellaro

Rosana Mastellaro

Sindusfarma, Brazil
Director, Technical Regulatory Affairs and Innovation
JM

Julia Maues

Patient-Centered Dosing Initiative, United States
Patient Advocate
avatar for Alex May

Alex May

District of Columbia, United States
North America Lead - Regulatory Science, Policy, & Intelligence
avatar for Christine Mayer-Nicolai

Christine Mayer-Nicolai

Merck Healthcare KGaA, Germany
Vice President, Regulatory and Scientific Policy
avatar for Susan Mayo

Susan Mayo

FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics
avatar for Christy Mazzarisi

Christy Mazzarisi

Network Partners Group, United States
Quality COE Lead
avatar for Cortez McBerry

Cortez McBerry

NDA Partners, United States
Partner
avatar for Sorcha McCrohan

Sorcha McCrohan

DIA, United States
Specialist, Scientific Programs
DM

Dezbee McDaniel

Clinispan Health, United States
CEO/Co-Founder
SM

Sarah McKeown-Cannon

Publicis Health, United States
Vice President, Growth
avatar for Lindsay McNair

Lindsay McNair

Equipoise Consulting, United States
Principal Consultant
avatar for Melodi McNeil

Melodi McNeil

AbbVie, United States
Director, Regulatory Policy and Intelligence
avatar for David Meats

David Meats

Certara, United States
Director, Regulatory Services Management
NM

N-Power Medicine

United States
avatar for Kevin Meek

Kevin Meek

PCM Trials, United States
Director, Supply Chain Operations
avatar for Munish Mehra

Munish Mehra

Tigermed, United States
Managing Director, Principal Biostatistician
avatar for Timothe Menard

Timothe Menard

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

Lubna Merchant

Pfizer Inc , United States
Director, Risk Management Center of Excellence
avatar for Danielle Metzger

Danielle Metzger

Network Partners Group, United States
Consultant
avatar for Joe Miles

Joe Miles

UiPath, United States
Industry Director, Life Sciences
avatar for Alexis Miller

Alexis Miller

Merck & Co., Inc., United States
Acting Global Lead, Global Regulatory Policy and Intelligence
avatar for Jennifer Miller

Jennifer Miller

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

Jessica Miller

GlaxoSmithKline, United States
1st-Year Fellow, Global Regulatory Affairs CMC
SM

Sam Miller

Exploristics, United Kingdom
Head of Strategic Consulting
avatar for Sandy Milligan

Sandy Milligan

Innovex Strategies, United States
Board of Director Member, Gossamer Bio; Principal
avatar for Pallavi Mishra-Kalyani

Pallavi Mishra-Kalyani

FDA, United States
Deputy Division Director, DBV, OB, CDER
avatar for Lauren Misztal

Lauren Misztal

Clario, United States
SVP, General Counsel
avatar for Marian Mitroiu

Marian Mitroiu

Biogen, Switzerland
Associate Director Biostatistics
avatar for Namosha Mohite

Namosha Mohite

Bayer, United States
Assistant Director, US Regulatory Affairs Liaison
avatar for Martha Monser

Martha Monser

FDA, United States
Consumer Safety Officer, Office of Regulatory Operations, CBER
MM

Michael Monteleone

FDA, United States
Associate Director for Labeling, OND, CDER
avatar for Yola Moride

Yola Moride

YolaRX Consultants, Canada
President
avatar for Susan Morris

Susan Morris

Susan Morris Coaching, United States
Professional Coach and Personal Growth Speaker
avatar for Rania Mouchantaf

Rania Mouchantaf

Health Canada, Canada
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
avatar for Lan Mu

Lan Mu

Bio-Thera Solutions, United States
Senior Vice President
avatar for David Mukanga

David Mukanga

Bill & Melinda Gates Foundation, United States
Deputy Director, Africa Regulatory Systems
avatar for Leyna Mulholland

Leyna Mulholland

Transent Group, United States
Executive Director, Global Regulatory Affairs
avatar for Joe Mullen

Joe Mullen

SciBite, United Kingdom
Head of Data Science and Professional Services
avatar for Theresa Mullin

Theresa Mullin

FDA, United States
Associate Center Director - Strategic Initiatives, CDER
AM

Alissa Mun

FDA, United States
Health Scientist Policy Analyst, OMP, CDER
avatar for Monica Munoz

Monica Munoz

FDA, United States
Division Director, Division of Pharmacovigilance-I, OSE, CDER
avatar for Melvin Munsaka

Melvin Munsaka

AbbVie, United States
Senior Director, Head Safety Statistics
avatar for Nancy Myers

Nancy Myers

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

Jane Myles

Decentralized Trials and Research Alliance (DTRA), United States
Program Director
avatar for Sridevi Nagarajan

Sridevi Nagarajan

AstraZeneca , United Kingdom
Head, Digital Regulatory Strategy
DN

David Nahamya

Uganda National Drug Authority, Uganda
Secretary to the Authority
avatar for Bijan Najafi

Bijan Najafi

Baylor College of Medicine, United States
Professor of Surgery; Director, Clinical Research
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Medidata AI, United States
Senior Director
TS

Tejendra Sri Ajith Nalluri

Northeastern University, United States
MS Regulatory Affairs Student
avatar for Rohit Nambisan

Rohit Nambisan

Lokavant, United States
CEO & Co-Founder
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

IPM, United States
Consultant
avatar for Sharmin Nasrullah

Sharmin Nasrullah

Salesforce, United States
General Manager, Life Sciences, Clinical
avatar for Edward Neilan

Edward Neilan

National Organization for Rare Disorders (NORD), United States
Chief Medical and Scientific Officer
avatar for Robert Nelson

Robert Nelson

Johnson & Johnson, United States
Executive Director, Pediatric Drug Development (CHILD)
avatar for Nancy Ngum

Nancy Ngum

University of Hertfordshire, United Kingdom
Student
avatar for Christiane Niederlaender

Christiane Niederlaender

Parexel International, United Kingdom
Vice President, Technical
avatar for Hubert Niewiadomski

Hubert Niewiadomski

Cledar, United States
Chief Executive Officer
IN

Ifeoma Njubigbo

University of Illinois Chicago, United States
PharmD Student
avatar for Yoshiaki Nodera

Yoshiaki Nodera

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Inspector, Office of Non-clinical and Clinical Compliance I
avatar for Lorraine Nolan

Lorraine Nolan

Health Products Regulatory Authority , Ireland
Chief Executive
avatar for Karen Noonan

Karen Noonan

Association of Clinical Research Organizations (ACRO), United States
Senior Vice President, Global Regulatory Policy
BN

Bridget Nugent

FDA, United States
Science Policy Analyst
avatar for Perla Nunes

Perla Nunes

Community Outreach and Clinical Research DEI Consultant, United States
Patient Advocate
CO

Catina O'Leary

Health Literacy Media, United States
President and Chief Executive Officer
avatar for Heiner Oberkampf

Heiner Oberkampf

ACCURIDS, Germany
CEO
avatar for Ashley Ogawa-Wong

Ashley Ogawa-Wong

Merck Sharp & Dohme LLC, United States
Associate Director, Regulatory Liaison
avatar for John Okudjeto

John Okudjeto

Janssen Research & Development LLC, United States
Manager, Pharmacovigilance QA
avatar for Lauren Oliva

Lauren Oliva

Biogen, United States
US Lead, Global Regulatory Policy
avatar for Carlos Orantes

Carlos Orantes

Alcanza Clinical Research, United States
Chief Executive Officer
avatar for John Overington

John Overington

Exscientia, United Kingdom
Chief Data Officer
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 Ana Padua

Ana Padua

EMD Serono, Switzerland
Director EU Global Regulatory and Scientific Policy
avatar for Lee Pai-Scherf

Lee Pai-Scherf

FDA, United States
Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER
avatar for Chockalingam Palaniappan

Chockalingam Palaniappan

Life Sciences Innovation Executive, United States
avatar for Gerald Dal Pan

Gerald Dal Pan

FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
avatar for Herbert Pang

Herbert Pang

Genentech, A Member of the Roche Group, United States
Expert Statistical Scientist
avatar for Raphael Pareschi

Raphael Pareschi

Roche, Brazil
Patient Safety Lead/ Head of Pharmacovigilance Brazil
avatar for Megan Parisi

Megan Parisi

Syneos Health, United States
Patient Solutions Lead
JP

Jay Park

Core Clinical Sciences, Canada
Scientific Lead and Founder
CP

Connie Pascual

Merck & Co., Inc., United States
Principal Scientist, Regulatory Digital Health
MP

Mayur Patel

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

Nital Patel

Consultant, United States
avatar for Miya Paterniti

Miya Paterniti

FDA, United States
Lead Physician, Division of Pulmonology, Allergy, and Critical Care,...
avatar for Vandana Pathak

Vandana Pathak

Amgen, United States
Director Global Regulatory Affairs
avatar for Rajneesh Patil

Rajneesh Patil

IQVIA, United States
Vice President, Clinical Operations
EP

Elizabeth Patterson

Synterex, Inc., United States
Business Operations Associate
avatar for David Pearce

David Pearce

Sanford Health, United States
President of Innovation and Research/Chair International Rare...
avatar for Doug Peddicord

Doug Peddicord

ACRO, United States
Executive Director
IP

Izabela Pedro

Hospital Israelita Albert Einstein, Brazil
Clinical Research Associate
avatar for Y. Veronica Pei

Y. Veronica Pei

FDA, United States
Acting Associate Director, Biomedical Informatics and Regulatory...
MP

Michael Pelosi

Astellas, United States
Director, Quality Analytics
KP

Keerthi Pendri

Northeastern University, United States
MS Regulatory Affairs Student
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

European Medicines Agency, Netherlands
Head of Clinical Trials Transformation Workstream
avatar for Vada Perkins

Vada Perkins

Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
avatar for Wesley Peters

Wesley Peters

Evidera/Thermo Fisher Scientific, United States
Research Specialist II, Patient Experience
MP

Mark Peterson

Vertex Pharmaceuticals, United States
Senior Director, Modeling and Simulation
avatar for Lionel Phillips

Lionel Phillips

Inside Edge Consulting, United States
President
avatar for Francesco Pignatti

Francesco Pignatti

European Medicines Agency, Netherlands
Scientific Adviser for Oncology
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

AbbVie, United States
Head, Regulatory Policy for Emerging Markets -Japan and Australia
avatar for Agustin Brito Del Pino

Agustin Brito Del Pino

Pfizer Inc, Uruguay
Regional Regulatory Hub Team Lead
avatar for Gino Pirri

Gino Pirri

PPD, part of Thermo Fisher Scientific, United States
VP Head Product & Technology
avatar for Laura Pizzi

Laura Pizzi

ISPOR, United States
Chief Science Officer
avatar for Jagdeep Podichetty

Jagdeep Podichetty

Critical Path Institute, United States
Senior Director of Predictive Analytics
avatar for Grzegorz (Greg) Podrygajlo

Grzegorz (Greg) Podrygajlo

CSL Behring, Switzerland
GRA CMC Director, Head of Global Manufacturing Support
avatar for Elena Polverejan

Elena Polverejan

Johnson & Johnson, United States
Scientific Director, Statistical Modeling and Methodology, Statistics...
avatar for Vaishali Popat

Vaishali Popat

FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic...
avatar for Douwe Postmus

Douwe Postmus

University Medical Center Groningen & EMA, Netherlands
Assistant Professor & Seconded National Expert
GP

Gregory Powell

GlaxoSmithKline, United States
Senior Director, Safety and Clinical Innovation
avatar for Sarah Powell

Sarah Powell

Powell Regulatory Services, United States
President
DP

Douglas Pratt

FDA , United States
Supervisory Medical Officer, OVRR, CBER
avatar for Regina Lynn Preciado

Regina Lynn Preciado

Content Rules, Inc., United States
Senior Director of Content Strategy Solutions
avatar for Scott Proestel

Scott Proestel

FDA, United States
Senior Medical Officer, ODES, OND, CDER, FDA
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
avatar for Rose Purcell

Rose Purcell

Takeda, United States
Director, Global Regulatory Policy and Innovation
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Bayer AG, United States
Vice President, Regulatory Affairs Americas
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
avatar for Christine Von Raesfeld

Christine Von Raesfeld

The Light Collective, United States
Founder/SME, Patient Experience
avatar for Motiur Rahman

Motiur Rahman

FDA, United States
Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER
avatar for Prasanna Rao

Prasanna Rao

Pfizer Inc, United States
Sr. Director, Global Head, AI/ML, Clinical Data Sciences
avatar for Rita Redberg

Rita Redberg

UCSF Medical Center, United States
Director, Women's Cardiovascular Services; Professor of Medicine
avatar for Sara Reed

Sara Reed

Consultant, United States
Video Production
avatar for Chara Reid

Chara Reid

Cencora (formerly AmerisourceBergen), United States
Director, Specialty Practice Network, Immunology
avatar for Ilona Reischl

Ilona Reischl

Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
avatar for Kim Ribeiro

Kim Ribeiro

AbbVie, United States
Head, Diversity and Patient Inclusion, Clinical Development Solutions
avatar for Brandon Rice

Brandon Rice

Weave, United States
Chief Product Officer
avatar for Margaret Richards

Margaret Richards

Panalgo, United States
Executive Director, Solutions
avatar for James Riddle

James Riddle

Advarra, United States
Senior Vice President, Global Review Operations
avatar for Sydney Ringold

Sydney Ringold

Cytel, Inc., United States
Customer Success Manager
avatar for Gerd Rippin

Gerd Rippin

IQVIA, Germany
Senior Director, Biostatistics, Real-World Solutions
avatar for MaryAnne Rizk

MaryAnne Rizk

Rizk Management Advisors, United States
Chief Executive Officer
avatar for Amanda Roache

Amanda Roache

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

John Roberts

Vyant Bio, Inc., United States
President and Chief Executive Officer
avatar for Tracey Robertson

Tracey Robertson

Boehringer Ingelheim Pharmaceuticals Inc., United States
Head of Patient and Site Engagement Capabilities
avatar for Laura Rodwell

Laura Rodwell

Dutch Medicines Evaluation Board, Netherlands
Statistical Assessor
LR

Liz Rogers

Pfizer , United States
Head of Global Site and Study Operations
avatar for Michelle Rohrer

Michelle Rohrer

Genentech Roche, United States
Senior Vice President, Global Head of Product Development Regulatory...
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 Maria Antonieta Roman

Maria Antonieta Roman

Novartis, Mexico
Head Regulatory Policy Emerging Markets LATAM
avatar for Josh Rose

Josh Rose

Hawthorne Effect, United States
Chief Executive Officer
avatar for Michael Rosenblatt

Michael Rosenblatt

Greenhouse Consulting, United States
Managing Director
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