Linked e-resources
Details
Table of Contents
Cover; Half title; Title; Copyright; Contents; Preface; Chapter 1. How to Train University Students in Regulatory Affairs; 1.1 Introduction; 1.2 A Sample of Regulatory Affairs Exercises for Students; 1.2.1 Background; 1.2.2 Lifelong Learning; Part 1 Introduction; Chapter 2. The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals; 2.1 Introduction; 2.2 Drivers of Change; 2.3 Historical Role and Skill Set of a Regulatory Professional.
2.4 Changing Role and Skill Set of the Regulatory Professional2.5 Develop as a Center of Intelligence; 2.6 Advance toward Strategic Relationship Management; 2.7 Develop as a Strategic Business Partner; 2.8 Conclusion: What Will It Take to Get There; Chapter 3. The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments; 3.1 Introduction; 3.2 Key Trends in the Asia Medical Device Industry; 3.3 The Role of the Asia RA Team in a Global Medical Device Organization; 3.4 Coordination between Commercial Teams and RA Teams.
3.5 The Role of the RA Team during the Different Stages of a Product Life3.5.1 Product Development; 3.5.2 Market Introduction; 3.5.3 Product Maintenance; 3.5.4 Product Phase-Out; 3.6 The RA Professional: A Trusted Advisor; 3.7 Summary; Chapter 4. Commercial Sense and What It Means for a Regulatory Manager or Executive; 4.1 Know the Basics; 4.1.1 Marketing or Commercial Plan; 4.1.2 Priority Products and How They Are Ranked in the Company; 4.1.3 Know Your Commercial People; 4.2 Maintain a Healthy Communication; 4.3 Be Proactive and Part of the Solution.
4.4 Remain the Expert and Provide Clarity to the Organization4.5 Be a Champion for New Product Launches; Chapter 5. Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally; 5.1 Introduction; 5.2 Information in Regulatory Strategy; 5.2.1 Device Name; 5.2.2 Device Description; 5.2.3 Intended Use; 5.2.4 Country of Interest; 5.2.5 Device Classification; 5.2.6 Product Registration or Conformity Assessment Route and Its Approval Timeline; 5.2.7 Technical Documentation Requirement; 5.2.8 Quality Management System Requirement.
5.2.9 Clinical Assessment5.2.10 Reimbursement Assessment; 5.3 Conclusion; Chapter 6. Regulatory Affairs as a Business Partner; Chapter 7. Introduction to Regulatory Affairs Professionals' Roles; Chapter 8. What It Means to Be a Medtech Regulatory Journalist; Chapter 9. Affordable Access to Medical Devices in Developing Countries; 9.1 Introduction; 9.2 Why Is Affordable Access to Medical Devices Important for Developing Countries; 9.2.1 Emergency Preparedness; 9.2.2 Efficiency and Effectiveness of Health Systems; 9.2.3 Health Equity; 9.3 Case Studies.
2.4 Changing Role and Skill Set of the Regulatory Professional2.5 Develop as a Center of Intelligence; 2.6 Advance toward Strategic Relationship Management; 2.7 Develop as a Strategic Business Partner; 2.8 Conclusion: What Will It Take to Get There; Chapter 3. The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments; 3.1 Introduction; 3.2 Key Trends in the Asia Medical Device Industry; 3.3 The Role of the Asia RA Team in a Global Medical Device Organization; 3.4 Coordination between Commercial Teams and RA Teams.
3.5 The Role of the RA Team during the Different Stages of a Product Life3.5.1 Product Development; 3.5.2 Market Introduction; 3.5.3 Product Maintenance; 3.5.4 Product Phase-Out; 3.6 The RA Professional: A Trusted Advisor; 3.7 Summary; Chapter 4. Commercial Sense and What It Means for a Regulatory Manager or Executive; 4.1 Know the Basics; 4.1.1 Marketing or Commercial Plan; 4.1.2 Priority Products and How They Are Ranked in the Company; 4.1.3 Know Your Commercial People; 4.2 Maintain a Healthy Communication; 4.3 Be Proactive and Part of the Solution.
4.4 Remain the Expert and Provide Clarity to the Organization4.5 Be a Champion for New Product Launches; Chapter 5. Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally; 5.1 Introduction; 5.2 Information in Regulatory Strategy; 5.2.1 Device Name; 5.2.2 Device Description; 5.2.3 Intended Use; 5.2.4 Country of Interest; 5.2.5 Device Classification; 5.2.6 Product Registration or Conformity Assessment Route and Its Approval Timeline; 5.2.7 Technical Documentation Requirement; 5.2.8 Quality Management System Requirement.
5.2.9 Clinical Assessment5.2.10 Reimbursement Assessment; 5.3 Conclusion; Chapter 6. Regulatory Affairs as a Business Partner; Chapter 7. Introduction to Regulatory Affairs Professionals' Roles; Chapter 8. What It Means to Be a Medtech Regulatory Journalist; Chapter 9. Affordable Access to Medical Devices in Developing Countries; 9.1 Introduction; 9.2 Why Is Affordable Access to Medical Devices Important for Developing Countries; 9.2.1 Emergency Preparedness; 9.2.2 Efficiency and Effectiveness of Health Systems; 9.2.3 Health Equity; 9.3 Case Studies.