Risk Management Principles for Devices and Pharmaceuticals (Hardcover)

This second edition includes expanded and updated risk management information on healthcare products around the world. Before a biologic, pharmaceutical or medical device product can be approved and marketed, and throughout its lifecycle, the manufacturer must prove that any risk(s) associated with its use has been reduced as far as possible. This book includes information on, among other things:

• preclinical, clinical and postmarketing risk evaluation
• regional risk management requirements
• benefit-risk assessment
• pregnancy registry use
• quality risk management

Table of Contents

• Chapter 1: The Impact of Preclinical Planning and Study Outcome on the Risk Management of Biologics 1
• Chapter 2: Risk Management Regulations in the US 11
• Chapter 3: Regulations Related to Risk Management in Japan 35
• Chapter 4: European Experience With Additional Risk Minimization and Its Impact on Benefit-Risk 41
• Chapter 5: Risk Management of Medicines and Biologics in Australia 49
• Chapter 6: Benefit-Risk Management: Current Trends and Future Directions 57
• Chapter 7: Risk Management in the Medical Device and Food Industries 63
• Chapter 8: Quality Risk Management (QRM)—A Gateway to Quality by Design (QbD) 71
• Chapter 9: Benefit-Risk Assessment: Art or Science? 79
• Chapter 10: Benefit-Risk Evaluation: Latest Regulatory Agency Innovation Activiti es 85
• Chapter 11: Use of Pregnancy Registries for Risk Management 95
• Chapter 12: Clinical Evaluation Reports 101
• Chapter 13: Risk Communication: Learning From Experts, Learning From Evidence 107 free
• Chapter 14: Postmarketing Pharmacoepidemiology Database Study Development to Evaluate Long-Term Drug Safety—An Example, Prolia 113
• Chapter 15: Risk Management in the Future: Looking Into the Crystal Ball 119
• Chapter 16: Social Science Theory as a Framework for Designing and Evaluating Pharmaceutical Risk Management Dissemination and Implementation Strategies 125
• Chapter 17: EHR Use for Stimulated Reporting of Adverse Drug Events 139
• Index 149
• About the Editors 159