Risk Management Principles for Devices and Pharmaceuticals
x
Lisette Hoogendoorn, PhD
Epidemiology Director
IQVIA
Chapter 13
Leo Hovestadt, MSc
Director Governmental Affairs
EU
Elekta
Chapters 7, 11 and 15
Yong Huang, MD, PhD
Associate Director
Bristol Myers Squibb Japan
Chapter 2
Tara Isherwood, MSc, BSc
(Hons)
Senior Director, Regulatory
Advice and Delivery
Syneos Health
Chapter 12 and 14
David Konadu, MSc, MASc
Senior Analyst, Quality
Systems
Edwards Lifesciences
Chapter 5
Richard Loomis, MD
Chief Informatics Officer,
Clinical Solutions
Elsevier
Chapter 19
Nadja Merkusheva, MD
Sr. Principal, Strategic RW
Solutions
IQVIA
Chapter 13
Andrej Miotk, PhD
Senior Product Vigilance
Manager
P&G
Chapter 10
Elaine H. Morrato, DrPH,
MPH, CPH
Founding Dean and Professor
Parkinson School of Health
Sciences and Public Health
Loyola University Chicago
Chapter 21
Hiroshi Nakane
Senior Manager
Gilead Sciences
Chapter 2
Darin Oppenheimer DRSc,
FRAPS, RAC
AVP Regulatory Affairs
Agilent Technologies
Chapter 3
Debra Porter, MS
Associate Director, Project
Management
Eli Lilly and Company
Chapter 1
Russ Roberson, PhD, MBA,
MScME, BScAgE
Chapter 9
Peter Schiemann, PhD, MBA
Managing Partner and
Co-Founder
Widler &Schiemann Ltd.
Chapter 8
Paul Sheehan, MSJ, BSc
Vice President
Synoes Health
Chapter 23
Meredith Y. Smith, PhD, MPA,
FISPE
Senior Director,
Implementation Science
Evidera, Inc., PPD, a part of
Thermo Fisher Scientific
Chapter 22
Michael Steinbuch, PhD,
FISPE
Senior Director, Global Head
of Postmarket Product
VIgilance
Procter &Gamble
Chapter 10
Tjeerd-Pieter van Staa, MD,
MSc, MA, PhD
Professor of Health eResearch
University of Manchester
Chapter 17
Priscilla Velentgas, PhD
Senior Principal
IQVIA
Chapter 13
Angela Walker, MD
Senior Director of Quality
Clinical Solutions
Chapter 19
Beat Widler, PhD, dipl. pharm.
med.
Managing Partner and
Co-Founder
Widler &Schiemann Ltd.
Chapter 8
Fei Xue, MD, MSC, ScD
Global Safety Medical Director,
Safety Officer
Amgen Inc.
Chapter 18
Brande Yaist, MS
Associate Vice President,
Value, Evidence and
Outcomes-Immunology
Eli Lilly and Company
Chapter 1
x
Lisette Hoogendoorn, PhD
Epidemiology Director
IQVIA
Chapter 13
Leo Hovestadt, MSc
Director Governmental Affairs
EU
Elekta
Chapters 7, 11 and 15
Yong Huang, MD, PhD
Associate Director
Bristol Myers Squibb Japan
Chapter 2
Tara Isherwood, MSc, BSc
(Hons)
Senior Director, Regulatory
Advice and Delivery
Syneos Health
Chapter 12 and 14
David Konadu, MSc, MASc
Senior Analyst, Quality
Systems
Edwards Lifesciences
Chapter 5
Richard Loomis, MD
Chief Informatics Officer,
Clinical Solutions
Elsevier
Chapter 19
Nadja Merkusheva, MD
Sr. Principal, Strategic RW
Solutions
IQVIA
Chapter 13
Andrej Miotk, PhD
Senior Product Vigilance
Manager
P&G
Chapter 10
Elaine H. Morrato, DrPH,
MPH, CPH
Founding Dean and Professor
Parkinson School of Health
Sciences and Public Health
Loyola University Chicago
Chapter 21
Hiroshi Nakane
Senior Manager
Gilead Sciences
Chapter 2
Darin Oppenheimer DRSc,
FRAPS, RAC
AVP Regulatory Affairs
Agilent Technologies
Chapter 3
Debra Porter, MS
Associate Director, Project
Management
Eli Lilly and Company
Chapter 1
Russ Roberson, PhD, MBA,
MScME, BScAgE
Chapter 9
Peter Schiemann, PhD, MBA
Managing Partner and
Co-Founder
Widler &Schiemann Ltd.
Chapter 8
Paul Sheehan, MSJ, BSc
Vice President
Synoes Health
Chapter 23
Meredith Y. Smith, PhD, MPA,
FISPE
Senior Director,
Implementation Science
Evidera, Inc., PPD, a part of
Thermo Fisher Scientific
Chapter 22
Michael Steinbuch, PhD,
FISPE
Senior Director, Global Head
of Postmarket Product
VIgilance
Procter &Gamble
Chapter 10
Tjeerd-Pieter van Staa, MD,
MSc, MA, PhD
Professor of Health eResearch
University of Manchester
Chapter 17
Priscilla Velentgas, PhD
Senior Principal
IQVIA
Chapter 13
Angela Walker, MD
Senior Director of Quality
Clinical Solutions
Chapter 19
Beat Widler, PhD, dipl. pharm.
med.
Managing Partner and
Co-Founder
Widler &Schiemann Ltd.
Chapter 8
Fei Xue, MD, MSC, ScD
Global Safety Medical Director,
Safety Officer
Amgen Inc.
Chapter 18
Brande Yaist, MS
Associate Vice President,
Value, Evidence and
Outcomes-Immunology
Eli Lilly and Company
Chapter 1