Contents: 1. How to Train University Students in RA 2. The Evolution of the Regulatory Professional:
Perspectives on the Skill Sets and Capabilities That Will Define the Next
Generation of Regulatory Professionals 3. The Role of the Asia Regulatory Affairs Team in Relation
to the Commercial Team and Other Departments 4. Commercial Sense and What It Means for a Regulatory
Manager or Executive 5. Medical Device Regulatory Strategy: Product Development
and Product Registration in Asia and Global 6. Regulatory Affairs as a Business Partner
7. Introduction to Regulatory Affairs Professionals’ Roles 8. What It Means to Be a Medtech Regulatory Journalist 9. Affordable Access to Medical Devices in Developing
Countries 10. Regulatory Specialists in Medical Devices in
Europe—Meeting the Challenge of Keeping Current in a Changing Environment: How
TOPRA Supports Professionals in a Dynamic Industry 11. Biomedical Device: Overview 12. Labeling, Label, and Language: A Truly Global Matter 13. Regulatory Affairs for Medical Device Clinical Trials in
Asia Pacific 14. Medical Device Classification Guide 15. ISO 13485:2003/2016—Medical Devices—Quality Management
Systems—Requirements for Regulatory Purposes 16. ISO 14971: Application of Risk Management to Medical
Devices 17. Medical Devices: IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance 18. United States Medical Device Regulatory Framework 19. Regulation of Combination Products in the United States 20. European Union: Medical Device Regulatory System
21. Regulation of Combination Products in the European Union
22. Medical Device Regulatory Affairs in Latin America
23. Saudi Arabia: Medical Device Regulation System
24. Australian Medical Device Regulations: An Overview
25. China: Medical Device Regulatory System
26. Hong Kong: Medical Device Regulatory System
27. India: Medical Device Regulatory System
28. Indonesia: Medical Device Regulatory System
29. Japan: Medical Device Regulatory System
30. Korea: Medical Device Regulatory System Malaysia: Medical
Device Regulatory System
31. Malaysia: Medical Device Regulatory System
32. Philippines: Medical Device Regulatory System and
Licensing
33. Singapore: Medical Device Regulatory System
34. Taiwan: Medical Device Regulatory System
35. Thailand: Regulatory and Medical Device Control
36. Vietnam: Medical Device Regulatory System
37. A Strong Regulatory Strategy
is a Competitive Advantage to a Medical Device Company |
