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Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products

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Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products

In recent years, therapeutic risk management has moved from an underdeveloped concept to a core competency for regulatory professionals. Here, for the first time, is a publication that addresses the whole spectrum of the global risk management revolution, from the high science to the intensely practical feet-on-the-ground application.

Tap into the expertise of regulators, contractors, academics and members of the global industry and examine risk management regulations in Australia, Canada, EU, Japan and the US. Gain insight into key elements of risk management; including preclinical planning, Quality Risk Management, risk: benefit assessment, clinical evaluation reports and risk communication.

» View the Table of Contents

Who would benefit from this publication?

This book is useful for individuals working on product development in regulated industries. Anyone involved in risk assessment and risk management in the pharmaceutical and medical device industry would benefit from the new information in this book.

Copyright © 2012, RAPS

Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products

Table of Contents

Chapter 1: The Impact of Preclinical Planning and Study Outcome on the Risk Management of Biologicals
By Dan Wierda, PhD, ATS
1
Chapter 2: Risk Management Regulations in the US
By Brande Ellis, MHS and Nayan Acharya
11
Chapter 3: Regulations Related to Risk Management in Japan
By Yong Huang, MD, PhD and Shinya Yamauchi
35
Chapter 4: European Perspective on Risk Management Plans and the Safety Specification
By Ursula M. Schmidt-Ott, MD, Stephen Heaton, MD and Gabriela Segretin
41
Chapter 5: Risk Management of Medicines and Biologicals in Australia
By Judy Bingham, FSHP, MHSc, GAICD
51
Chapter 6: Risk Management in Canada
By Ella Dratewka-Kos, PhD, Sunita Phull and Adriana Ziff, MSc, RPh
59
Chapter 7: Risk Management in the Medical Device and Food Industries
By Salma Michor, PhD, MBA, CMgr, RAC
65
Chapter 8: Quality Risk Management (QRM) a Gateway to Quality by Design (QbD)
By Beat Widler, PhD and Peter Schiemann, PhD
71
Chapter 9: Risk:Benefit Assessment: Art or Science?
By Mariette Boerstoel-Streefland, MD, MBA, MS(epi)
81
Chapter 10: Evaluation of Benefit:Risk—Latest Innovation Activities by Regulatory Agencies
By Elaine B. Taylor and Kiley DePolo
87
Chapter 11: Use of Pregnancy Registries for Risk Management
By Vikki D. Brown, MD, Jessica D. Albano, PhD, MPH, Kristin Phelps and Jean Whitehouse, RN
95
Chapter 12: Clinical Evaluation Reports
By Evangeline D. Loh, PhD, RAC and Chris Brodrick, MS (BME)
101
Chapter 13: Cancer Drugs Register of the Italian Medicines Agency and Its Use in Risk Management
By Luca De Nigro and Entela Xoxi, PhD
107
Chapter 14: Risk Communication: Learning from Experts, Learning from Evidence
By Lee L. Zwanziger
113
Chapter 15: Risk Management in the Future: Looking Into the Crystal Ball
By Tjeerd-Pieter van Staa, MD, PhD, MSc, MA
119
Chapter 16: Social Science Theory as a Framework for Designing and Evaluating Pharmaceutical Risk Mitigation Dissemination and Implementation Strategies
By Elaine H. Morrato, DrPH, MPH, CPH
125
Index 139
About the Editors 145

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