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avatar for Sarrit Kovacs

Sarrit Kovacs

FDA
Clinical Outcome Assessments (COA) Staff, OND, CDER
avatar for Michael Krams

Michael Krams

Janssen Pharmaceuticals, Inc.
Vice President, Global Head Quantitative Sciences
MK

Michael Kranz

Experient, Inc.
avatar for James Kremidas

James Kremidas

Association of Clinical Research Professionals (ACRP)
Executive Director
avatar for Mark Kryah

Mark Kryah

Eli Lilly and Company
Senior Advisor/COO, Bio-Medicines Business Unit
avatar for Wayne Kubick

Wayne Kubick

HL7
Chief Technology Officer
avatar for Jürgen Kübler

Jürgen Kübler

CSL Behring GmbH
Global Head, Quantitative Safety Sciences
avatar for Jürgen Kübler

Jürgen Kübler

CSL Behring GmbH
Global Head, Quantitative Safety Sciences
PK

Prajna Kumar

Texila American University
PhD Candidate
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

DIA
Global Chief Executive
avatar for Tatsuo Kurokawa

Tatsuo Kurokawa

Japan Self-Medication Industry
President
avatar for John Kurtz

John Kurtz

Janssen R & D, LLC
Senior Director, External Alliances
avatar for Rebecca Kush

Rebecca Kush

CDISC
President and Chief Executive Officer
avatar for Sandra Kweder

Sandra Kweder

FDA
Deputy Director, Liaison to the EMA, Office of International...
avatar for Michael Laddin

Michael Laddin

LeaderPoint
Chief Executive Officer
DL

Dominique Lagrave

Amgen
Director, Global Regulatory Affairs and Safety Operations
avatar for Reshma Lakhram

Reshma Lakhram

Touro College of Pharmacy
Student
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Tufts Center for the Study of Drug Development
Associate Director of Sponsored Research, Research Assistant Professor
TL

Terri Landis

SPARGO, Inc.
KL

Karyn Lasky

TKL Research, Inc.
Director, Clinical Operations
CL

Camilla Lau

Gilead Sciences
Sr. Clinical Trial Manager
avatar for Hai-Ha Le

Hai-Ha Le

Claude Bernard Lyon 1 University
PhD Candidate, Pharmacology
avatar for David LeDuc

David LeDuc

Addario Lung Cancer Medical Institute
Senior Director of Strategic Alliances
avatar for Andy Lee

Andy Lee

Merck & Co., Inc.
Senior Vice President, Head of Global Clinical Trial Operations
avatar for Cecil Lee

Cecil Lee

Eli Lilly and Company
Knowledge Management Advisor, Global Customer Information
avatar for Jeffrey Lee

Jeffrey Lee

mProve Health
Chief Executive Officer
avatar for Jessie Lee

Jessie Lee

Quintiles
Associate Director, Site and Patient Networks
avatar for Amy Leitman

Amy Leitman

NTM Info & Research
Director of Policy & Advocacy
avatar for Bhavish Lekh

Bhavish Lekh

Quintiles
Associate Global Feasibility Lead
JL

Jennifer Lentz

Eli Lilly and Company
Consultant, Global Informed Business Lead
LL

Lauralee Leonard

Bristol-Myers Squibb Company
Senior Medical Writer
avatar for Patricia Leuchten

Patricia Leuchten

The Avoca Group
Chief Executive Officer and President
GL

Gregory Levin

FDA
Mathematical Statistician, Office of Translational Sciences, CDER
avatar for Bennett Levitan

Bennett Levitan

Janssen Research & Development, LLC
Senior Director, Benefit-Risk Assessment, Department of Epidemiology
avatar for Debra Lewis

Debra Lewis

Food and Drug Administration
Deputy Director, Office of Orphan Products Development
CL

Charles Li

Teva Pharmaceuticals
Statistician
avatar for Lawrence Liberti

Lawrence Liberti

Centre for Innovation in Regulatory Science (CIRS)
Executive Director
avatar for Xiu Wei Lim

Xiu Wei Lim

Quintiles
Regional Clinical Innovation and Operational Excellence Head
YP

Yen Ping Lim

National University of Singapore
Student
avatar for Elizabeth Lincoln

Elizabeth Lincoln

DIA
Global Director of Engagement
avatar for Wendy Lipworth

Wendy Lipworth

University of Sydney
Senior Research Fellow, Centre for Values, Ethics and the Law in...
DL

Daniel Liu

Beijing Clinical Service Center
Chief Scientific Officer
avatar for Feng Liu

Feng Liu

GlaxoSmithKline
Manager, Statistics, RD Projects Clinical Platforms and Sciences
KL

Kenneth Liu

Merck & Co. Inc.
Senior Principal Scientist
RL

Richard Lostritto

FDA
Acting Director, Office of Policy for Pharmaceutical Quality, OPQ,...
avatar for Victor Lu

Victor Lu

FDA
Biologist, Office of Cellular, Tissue and Gene Therapies, CBER
avatar for Elizabeth Luczak

Elizabeth Luczak

Covance Inc.
Vice President, Regulatory Compliance Quality Assurance
RM

Richard Macaulay

PAREXEL Access Consulting
Senior Consultant
avatar for Tom Macfarlane

Tom Macfarlane

Accenture Accelerated R&D Services
Director, Life Sciences
avatar for Cheryl Mahon

Cheryl Mahon

Astellas Pharma US, Inc.
Director, Clinical Pharmacy
avatar for Amita Malik

Amita Malik

Oracle Health Sciences
Senior Manager, Product Management
JM

John Manganaro

Bayer HealthCare Pharmaceuticals
Deputy Director, Regulatory Policy and Intelligence
avatar for Anabela Marcal

Anabela Marcal

European Medicines Agency (EMA),
Head of Committees and Inspections Department
avatar for Heidi Marchand

Heidi Marchand

FDA
Assistant Commissioner, Office of Health and Constituent Affairs, OC
avatar for Robin Marcus

Robin Marcus

GlobalCare Clinical Trials
SVP Business Development & Strategic Initiatives
avatar for Karen Marks

Karen Marks

Baxter International, Inc.
Vice President, Global Program Management Office
avatar for Peter Marks

Peter Marks

FDA
Director, Center for Biologics Evaluation and Research
avatar for Micheline Marshall

Micheline Marshall

Janssen Pharmaceutical Companies of Johnson & Johnson
Head Randomization and Trial Supply Management
LM

Linda Martin

KMR Group Inc.
President and Founder
avatar for Scott Martin

Scott Martin

KMR Group Inc.
Principal
avatar for Philip Masaitis

Philip Masaitis

Philadelphia College of Pharmacy, University of the Sciences
Student
avatar for Andrea Masciale

Andrea Masciale

Johnson & Johnson
Vice President, Regulatory Policy and Global Analytics
JM

Julie Massicotte

Algorithme Pharma
Director, Clinical Pharmacology and Regulatory Affairs
avatar for Tammy Massie

Tammy Massie

National Institutes of Health (NIH)
Mathematical Statistician, Office of Equal Opportunity and Customer...
avatar for Chris Matheus

Chris Matheus

Matheus BD Connections
President
avatar for Christopher Matheus

Christopher Matheus

YPrime Inc
Director, Business Development
RM

Ramya Mathew

Rutgers, The State University of New Jersey
Post-Doctoral Fellow, Medical Affairs
avatar for Tomoko Matsumoto

Tomoko Matsumoto

Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
avatar for Christa Maurer

Christa Maurer

Bristol-Myers Squibb Company
Sr. Compliance Specialist
avatar for Russell Maus

Russell Maus

Merck & Co., Inc.
Director
avatar for Steve Mayall

Steve Mayall

Pope Woodhead & Associates Ltd
Principal Consultant
avatar for Philomena McArthur

Philomena McArthur

Johnson & Johnson International
Vice President Global Policies, Procedures & Training, Healthcare...
avatar for Neil McAuslane

Neil McAuslane

Centre For Innovation In Regulatory Science (CIRS)
Director
avatar for Mark McCamish

Mark McCamish

Sandoz, Inc
Global Head Biopharm and Oncology Injectables Development
avatar for Deirdre McCarthy

Deirdre McCarthy

Quintiles Inc.
Senior Benefit Risk Management Director
avatar for K. Kimberly McCleary

K. Kimberly McCleary

FasterCures, A Center of the Milken Institute
Managing Director
NM

Neil McCullough

ICON Clinical Research
Executive Vice President, Clinical Quality Compliance
DM

Dan McDonald

Imperial
Director, Business Development
avatar for Newell McElwee

Newell McElwee

Merck & Co., Inc.
Assistant Vice President, Center for Observational and Real-world...
MM

Maureen McGee

Merck & Co., Inc.
Senior Scientist
avatar for Denisa McKnight

Denisa McKnight

Roche Products Limited
Patient Engagement and Media
RM

Richard McNally

Covance Inc.
Statistical Fellow
avatar for Christine McSherry

Christine McSherry

Jett Foundation
Executive Director
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Johnson & Johnson
Senior Director/ Head, BioResearch Quality and Compliance, Consumer...
avatar for Manthan Mehta

Manthan Mehta

Topiwala National Medical College & BYL Nair Charitable Hospital
avatar for Andrew Melli

Andrew Melli

SOUSEIKAI Global Clinical Research Center
Senior Manager
avatar for Lubna Merchant

Lubna Merchant

FDA
Deputy Office Director, OMEPRM, OSE, CDER
avatar for Sanjeev Miglani

Sanjeev Miglani

APCER Life Sciences
Vice President-PV and Clinical Safety North America and Global...
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

FDA
Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance,...
avatar for Christopher Milan

Christopher Milan

Touro College of Pharmacy
Pharmacy Student, Phi Lambda Sigma Chapter President
avatar for Lewis Millen

Lewis Millen

Roche Products Limited
Operational Intelligence Leader
avatar for Colin Miller

Colin Miller

BrackenData
CEO
avatar for Eva Miller

Eva Miller

Self-Employed
Independent Biostatistical Consultant
avatar for Kristen Miller

Kristen Miller

FDA
Health Scientist Policy Analyst, Office of Medical Policy, CDER
avatar for Sandra Milligan

Sandra Milligan

Merck Research Laboratories
Senior Vice President, Head of Global Regulatory Affairs and Clinical...
avatar for Marsha Millikan

Marsha Millikan

Eli Lilly and Company
Advisor, Expedited Reporting Global Patient Safety
avatar for Christopher Milne

Christopher Milne

Tufts Center for the Study of Drug Development
Director of Research and Research Associate Professor
avatar for Michael Minor

Michael Minor

ICON Peri-Approval and Observational Research
Senior Vice President, Global Head Operations and Strategic Planning
avatar for Alan Minsk

Alan Minsk

Arnall Golden Gregory LLP
Partner, Head of Food and Drug Team
avatar for Ed Miseta

Ed Miseta

Life Science Connect
Editor
avatar for Kenneth Moch

Kenneth Moch

Salutramed Group, LLC
Managing Partner
CM

Christopher Moen

Choroideremia Research Foundation
President
avatar for Jonathan Mogford

Jonathan Mogford

Medicines and Healthcare products Regulatory Agency (MHRA),
Director of Policy
avatar for Ganapathy Mohan

Ganapathy Mohan

Merck & Co., Inc.
Head of External Affairs (Quality)
avatar for Gaz Monteath

Gaz Monteath

Link Global Solution Inc.
Executive Director
avatar for Ed Morgan

Ed Morgan

Health Canada
Director General, Policy, Planning and International Affairs...
LM

Linda Morgan

Parkinson's Disease Foundation
Patient Representative FDA, Research Advocate; Chair, Patient...
avatar for Daichi Mori

Daichi Mori

Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
avatar for Elaine Morrato

Elaine Morrato

Colorado School of Public Health
Professor Health Systems, Management and Policy
EM

Eric Morrie

ClinCapture
Director, Product Operations
avatar for Sandra Morris

Sandra Morris

Johnson & Johnson
Vice President, Strategy Realization
avatar for Michael Mosier

Michael Mosier

EMB Statistical Solutions, LLC
Director, Biostatistics
avatar for Stephan de la Motte

Stephan de la Motte

Synteract HCR
Chief Medical Advisor
avatar for Stephan de la Motte

Stephan de la Motte

Synteracthcr
Chief Medical Advisor
avatar for Isabelle Moulon

Isabelle Moulon

European Medicines Agency, European Union
Head of Patients and Healthcare Professionals Department
avatar for Willie Muehlhausen

Willie Muehlhausen

ICON
Head of Innovation
avatar for JoAnn Muir

JoAnn Muir

Novartis Pharmaceuticals Corporation
Global Head Franchise Quality Assurance
avatar for Andrew Mulberg

Andrew Mulberg

FDA
Deputy Division Director, Gastroenterology and Inborn Errors...
avatar for Jean Mulinde

Jean Mulinde

FDA
Medical Officer, Senior Policy Advisor, OSI, OC, CDER
RM

Rebecca Mullen

Northwestern University
avatar for Theresa Mullin

Theresa Mullin

FDA
Associate Director for Strategic Initiatives, OCD, CDER
CM

Catherine Mulvale

Canadian Digestive Health Foundation
Executive Director (CDHF)
MM

Madoka Murakami

Pharmaceuticals and Medical Devices Agency (PMDA)
Unit Chief, Division of Regulatory Cooperation, Office of...
avatar for Noriaki Murao

Noriaki Murao

NM Consulting
Representative
MM

Mary Murphy

FDA
Director, Office of Pediatric Therapeutics, Office of Special Medical...
KM

Kristin Murray

Shire Pharmaceuticals
Director, Global CMC Regulatory Affairs
avatar for Mary Murray

Mary Murray

Bristol-Myers Squibb Company
Associate Director, Diversity and Patient Engagement
avatar for Nathan Murray

Nathan Murray

Eli Lilly and Company
Global PRA Advisor, Autoimmune
avatar for Richard Murray

Richard Murray

Merck & Co., Inc.
Vice President and Deputy Chief Medical Officer
avatar for Sharon Murray

Sharon Murray

PAREXEL
Associate Director, Biostatistics
avatar for Bob Muzerall

Bob Muzerall

AMPLEXOR Life Sciences, LLC
Vice President, Sales and Sales Training
avatar for Bob Muzerall

Bob Muzerall

AMPLEXOR Life Sciences, LLC
Vice President, Sales & Sales Training
avatar for Jack Mycka

Jack Mycka

Medical Marketing Economics LLC (MME)
Global President and CEO
avatar for Nancy Myers

Nancy Myers

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

Jane Myles

Genentech, A Member of the Roche Group
Head, Operational Intelligence and Innovation
RN

Raj Nair

FDA
Medical Officer, DPARP, OND, CDER
MN

Masahide Nakajima

Mitsubishi Tanabe Pharma Corporation
Manager, Pharmacovigilance Cordination & Administration Department....
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Ministry of Health, Labour and Welfare (MHLW)
Director, Office of International Regulatory Affairs
avatar for Mehdi Namil

Mehdi Namil

University of North Texas Health Science Center
Student, College of Pharmacy
avatar for Gopalan Narayanan

Gopalan Narayanan

NDA Group
Biologics and Advanced Therapies Expert
avatar for Moheb Nasr

Moheb Nasr

GlaxoSmithKline
Vice President, CMC Regulatory Strategy
avatar for Nariman Nasser

Nariman Nasser

Roche
Digital Strategist, Operational Intelligence and Innovation
avatar for Elizabeth Nauman

Elizabeth Nauman

Louisiana Public Health Institute (LPHI)
Research Director, Research Action for Health Network (REACHnet)
avatar for Saumya Nayak

Saumya Nayak

QuintilesIMS
Associate Director, Patient Recruitment Programs, Asia Pacific
avatar for Nersi Nazari

Nersi Nazari

Vital Connect, Inc.
Chairman and Chief Executive Officer
DN

Diane Neiman

Merck & Co., Inc.
Director, Global Project Management
avatar for Hilary Nelson

Hilary Nelson

Genentech, A Member of the Roche Group
Senior Clinical Program Leader
avatar for Robert Nelson

Robert Nelson

FDA
Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric...
avatar for Dawn Niccum

Dawn Niccum

Endocyte
Associate Director, Quality
avatar for Derenda Nichols

Derenda Nichols

Medpace
Senior Director, Clinical Trial Management
avatar for C. David Nicholson

C. David Nicholson

Allergan
Executive Vice President, Brand R&D
avatar for Virginia Nido

Virginia Nido

Genentech, A Member of the Roche Group
Head, Industry Collaborations
avatar for Rebecca Noel

Rebecca Noel

Eli Lilly and Company
Global Benefit-Risk Lead, Global Patient Safety
avatar for Lorraine Nolan

Lorraine Nolan

Health Products Regulatory Authority (HPRA)
Chief Executive
avatar for Amy Nordo

Amy Nordo

Duke University
Product Manager, Maestro Care (Epic) for Research and eSource
avatar for Jami Norris

Jami Norris

Quintiles
Vice President, Clinical Development Strategic Partnerships
JN

Jennifer North

Beyond Celiac
Vice President
avatar for Kim Northam

Kim Northam

Accenture Accelerated R&D Services
Manager, Regulatory Affairs
avatar for Roger Nosal

Roger Nosal

Pfizer Inc
Vice President, Global CMC
avatar for Chris O'Shaughnessy

Chris O'Shaughnessy

C3i Healthcare Connections
Vice President, Sales
avatar for Armando Oliva

Armando Oliva

Semantica LLC
President and Chief Medical Officer
avatar for Sharon Olmstead

Sharon Olmstead

Novartis Pharmaceuticals Corporation
Global Head, Development and Regulatory Policy
avatar for Carrie Ostrea

Carrie Ostrea

Global Genes - Allies In Rare Disease
Senior Manager, Patient Advocacy
avatar for Naohiro Otaki

Naohiro Otaki

Pharmaceuticals and Medical Devices Agency (PMDA)
Technical Officer, Application Review Division I, Office of Relief...
avatar for Kate Owen

Kate Owen

Novo Nordisk Inc.
Vice President, Clinical Trial Management
avatar for Robert Paarlberg

Robert Paarlberg

Paarlberg & Associates LLC
Principal
MP

Michael Pacanowski

FDA
Associate Director for Genomics and Targeted Therapy, OCP, CDER
CP

Carol Pamer

FDA
Program Lead for Pharmacovigilance, OSE, CDER
avatar for Gerald Dal Pan

Gerald Dal Pan

FDA
Director, Office of Surveillance and Epidemiology
IP

Irene Pan

UBC: An Express Scripts Company
Senior Research Scientist
ZQ

Zhiying "Jean" Pan

Amgen Inc.
Senior Manager, Biostatistics
EP

Elektra Papadopoulos

FDA
Associate Director, Clinical Outcome Assessments Staff, OND, CDER
AP

Anna Papinska

University of Southern California
PhD candidate
avatar for Todd Paporello

Todd Paporello

Bayer HealthCare Pharmaceuticals
Vice President and Head of North American Regulatory Affairs
NP

Nihar Parikh

CitiusTech Inc.
Healthcare Consultant
avatar for Samarth Parikh

Samarth Parikh

Janssen Pharmaceutical Companies of Johnson & Johnson
Postdoctoral Fellow
avatar for Min Soo Park

Min Soo Park

KCGI
Chair
avatar for James Parrott

James Parrott

Rutgers, The State University of New Jersey
Associate Professor
AP

Anisha Patel

Virginia Commonwealth University School of Pharmacy
PhD Candidate, Department of Pharmacotherapy and Outcomes Science
avatar for Bakul Patel

Bakul Patel

FDA
Associate Director for Digital Health, Office of the Center Director,...
avatar for Kinnari Patel

Kinnari Patel

Rocket Pharmaceuticals
Vice President, Head of Regulatory, Pharmacovigilance, and Compliance
avatar for Mira Patel

Mira Patel

University of Arizona
PhD Student, Pharmaceutical Economics, Policy, and Outcomes
PP

Prisha Patel

Centre For Innovation In Regulatory Science (CIRS)
Manager, Global Development Programme
RP

Rohini Patil

Cognizant
Manager, Life Sciences Business Consulting
avatar for Matthew Pazdernik

Matthew Pazdernik

Merck & Co., Inc.
Director, Regulatory Submission Planning and Portfolio Management
avatar for Eric Peacock

Eric Peacock

MyHealthTeams
Co-founder and Chief Executive Officer
avatar for Doug Peddicord

Doug Peddicord

Association of Clinical Research Organizations (ACRO)
Executive Director
avatar for Lisa Peluso

Lisa Peluso

PharmApprove, a member of the NDA Group
Director, Coaching and Client Engagement
VP

Vada Perkins

FDA
Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER
avatar for Jane Perlmutter

Jane Perlmutter

Gemini Group
Founder and President
avatar for Mark Perrott

Mark Perrott

Pope Woodhead
Head of Development Consulting
avatar for Debbie Persaud

Debbie Persaud

NNIT Inc.
Regulatory Affairs SME
avatar for Julia Petses

Julia Petses

Sanofi US
Director, Medical Information Services, Diabetes
avatar for Julia Petses

Julia Petses

Sanofi US
Director, Medical Information Services, Diabetes
MP

Michael Phillips

ICON plc
Director, Product Innovation
avatar for Patrick Phillips

Patrick Phillips

Health Decisions, Inc.
Chief Executive Officer
avatar for John Piccone

John Piccone

IBM Watson Health
Lead Partner Life Sciences Strategy and Analytics


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