Risk Management Principles for Devices and Pharmaceuticals
iii
Table of Contents
Author Acknowledgments........................................................................................................................ix
SECTION I: Risk Management Regulations................................................................................ 1
Chapter 1 Risk Management Regulations in the US............................................................................3
Brande Yaist, MS Debra Porter, MS Debashish Dey, MD, PhD, MPH and Nayan Achayara
MBBS, MRCP, MFPM
Chapter 2 Regulations Related to Risk Management in Japan...........................................................39
Yong Huang, MD, PhD Krishna Bahadursingh, MD, FRCS, MBA, LLB, FFPM
and Hiroshi Nakane
Chapter 3 European Experience with Additional Risk Minimization and its Impact on
Benefit-Risk.......................................................................................................................49
Darin Oppenheimer DRSc, FRAPS, RAC and George Cusatis MS, RAC
Chapter 4 Risk Management of Medicines and Biologicals in Australia............................................59
Judy Bingham, MHA, GAICD
Chapter 5 Risk Management in Canada.............................................................................................71
David Konadu, MSc, MASc
SECTION II: Benefit-Risk Management Principles and Practices. ..............................................83
Chapter 6 The Impact of Preclinical Planning and Study Outcome on the Risk Management of
Biologicals..........................................................................................................................85
Michael Engwall, DVM, PhD, DSP
Chapter 7 Risk Management in Medical Devices and Artificial Intelligence.....................................99
Leo Hovestadt, MSc
Chapter 8 Quality Risk Management: A Gateway to Quality by Design.........................................121
Beat Widler, PhD, dipl. pharm. med., and Peter Schiemann, PhD, MBA
Chapter 9 Quality Management Systems for Medical Devices. .......................................................133
Russ Roberson, PhD, MBA, MScME, BScAgE
Chapter 10 Risk Management Principles and Processes for OTC Medicines....................................153
Michael Steinbuch, PhD, FISPE, Matthew Francis, MS, PhD, and Andrej Miotk, PhD
iii
Table of Contents
Author Acknowledgments........................................................................................................................ix
SECTION I: Risk Management Regulations................................................................................ 1
Chapter 1 Risk Management Regulations in the US............................................................................3
Brande Yaist, MS Debra Porter, MS Debashish Dey, MD, PhD, MPH and Nayan Achayara
MBBS, MRCP, MFPM
Chapter 2 Regulations Related to Risk Management in Japan...........................................................39
Yong Huang, MD, PhD Krishna Bahadursingh, MD, FRCS, MBA, LLB, FFPM
and Hiroshi Nakane
Chapter 3 European Experience with Additional Risk Minimization and its Impact on
Benefit-Risk.......................................................................................................................49
Darin Oppenheimer DRSc, FRAPS, RAC and George Cusatis MS, RAC
Chapter 4 Risk Management of Medicines and Biologicals in Australia............................................59
Judy Bingham, MHA, GAICD
Chapter 5 Risk Management in Canada.............................................................................................71
David Konadu, MSc, MASc
SECTION II: Benefit-Risk Management Principles and Practices. ..............................................83
Chapter 6 The Impact of Preclinical Planning and Study Outcome on the Risk Management of
Biologicals..........................................................................................................................85
Michael Engwall, DVM, PhD, DSP
Chapter 7 Risk Management in Medical Devices and Artificial Intelligence.....................................99
Leo Hovestadt, MSc
Chapter 8 Quality Risk Management: A Gateway to Quality by Design.........................................121
Beat Widler, PhD, dipl. pharm. med., and Peter Schiemann, PhD, MBA
Chapter 9 Quality Management Systems for Medical Devices. .......................................................133
Russ Roberson, PhD, MBA, MScME, BScAgE
Chapter 10 Risk Management Principles and Processes for OTC Medicines....................................153
Michael Steinbuch, PhD, FISPE, Matthew Francis, MS, PhD, and Andrej Miotk, PhD