Risk Management Principles for Devices and Pharmaceuticals
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Author Acknowledgments
RAPS and lead editor, J. Michael Sprafka, MPH, PhD, thank the following subject matter experts for shar-
ing their experience and knowledge and volunteering their time to contribute to this third edition of Risk
Management Principles for Devices and Pharmaceuticals.
Nayan Achayara, MBBS,
MRCP, MFPM
Chapter 1
Jessica D. Albano, PhD, MPH
VP, Epidemiology &Analytics
Syneos Health
Chapter 14
Krishna Bahadursingh, MD,
FRCS, MBA, LLB, FFPM
Head of WorldWide Patient
Safety-Japan
Bristol Myers Squibb
Judy Bingham, MHA, GAICD
Executive Director
Easington Pty Ltd
Chapter 4
Mariette Boerstoel-Streefland,
MD, MSc, MBA
Chief Safety Officer, SVP
Patient Safety
AstraZeneca
Chapter 16
Brian Buysse, PhD
Senior Director, Epidemiology
Syneos Health
Chapter 14
Jemma Contreras, PhD
Advisory Group Lead, R&D
Consulting
Syneos Health
Chapter 23
Lindsay Crampton, BSc
Advisory Group Lead, Risk
&Program Management,
Consulting
Syneos Health
Chapter 23
George Cusatis MS, RAC
Sr. Regulatory Affairs Manager
Medtronic
Chapter 3
Karin de Haart, MSc
Product Strategy Lead
IQVIA
Chapter 13
Bruce R. DeMark, PhD
Retired Research Fellow
Procter &Gamble
Pharmaceuticals
Chapter 20
Debashish Dey, MD, PhD,
MPH
Vice President &Head, Drug
Safety &Pharmacovigilance
Intellia Therapeutics
Bernadette Dwan, BSc,
Mpharm, MPSI
Product Strategy Lead
IQVIA
Chapter 13
Michael Engwall, DVM, PhD,
DSP
Chapter 6
Sara Ephross, PhD
Senior Director, Epidemiology
Syneos Health
Chapter 14
Matthew Francis, MS, PhD
Epidemiologist
Proctor and Gamble
Chapter 10
Angie Graves, MBA,
MLS(ASCP)
Senior Director, Business
Operations, Real World &
Late Phase
Syneos Health
Chapter 14
Mark Heinemann, BSc
Associate Director, Regulatory
Advice &Delivery
Syneos Health France SARL
Chapter 12