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06903nam a22002417a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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20250522101152.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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250522b |||||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9789814877862 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615.23 |
| Item number |
WON |
| 245 ## - TITLE STATEMENT |
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| Title |
Medical regulatory affairs: |
| Remainder of title |
an international handbook for medical devices and healthcare products |
| 250 ## - EDITION STATEMENT |
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| Edition statement |
3rd |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
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| Name of publisher, distributor, etc. |
Jenny Stanford Publishing |
| Place of publication, distribution, etc. |
Singapore |
| Date of publication, distribution, etc. |
2022 |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
xxxix, 765 p. |
| 365 ## - TRADE PRICE |
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| Price type code |
GBP |
| Price amount |
193.00 |
| 500 ## - GENERAL NOTE |
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| General note |
Table of Contents:<br/><br/>1. How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth after the COVID-19 Impact <br/>Raymond K. Y. Tong <br/>Part 1: Introduction <br/>2. The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals <br/>David Martin and Neil Lesser <br/>3. The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments <br/>Fredrik Dalborg <br/>4. Commercial Sense and What It Means for a Regulatory Manager or Executive <br/>Annie Joseph <br/>5. Market Strategic Challenges for Medical Device (Asia/Pacific) <br/>Sherwin Tan, Ki Eunyu, Kyser Tay, and David Lee <br/>6. Regulatory Affairs as a Business Partner <br/>Claudette Joyce C. Perilla <br/>7. Introduction to Regulatory Affairs Professionals’ Roles <br/>Dacia Su <br/>8. What It Means to Be a Medtech Regulatory Journalist <br/>Amanda Maxwell <br/>9. Accelerating Access to in vitro Diagnostics: Urgent Need for Increasing the Speed and Efficiency of Regulatory Review and Policy Development for in vitro Diagnostics for Antimicrobial Resistance and Epidemic Preparedness and Response <br/>Rosanna W. Peeling, David Heymann, Noah Fongwen, Oliver Williams, Joanna Wiecek, Phil Packer, and Gabriela Juarez-Martinez <br/>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 <br/>Lynda J. Wight <br/>Part 2: Medical Device Safety and Related ISO Standards <br/>11. Biomedical Devices: Overview <br/>Piu Wong <br/>12. Labeling, Label, and Language: A Truly Global Matter <br/>Evangeline D. Loh and Jaap L. Laufer <br/>13. Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific <br/>Seow Li-Ping Geraldine <br/>14. Medical Device Classification Guide <br/>Patricia Teysseyre <br/>15. ISO 13485:2016: Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes <br/>Gert Bos <br/>16. ISO 14971: Application of Risk Management to Medical Devices <br/>Tony Chan and Raymond K. Y. Tong <br/>17. Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance <br/>Gabriela Ehrlich <br/>18. Good Submission Practice <br/>Shinji Hatakeyama and Isao Sasaki <br/>Part 3: Medical Device Regulatory System in the United States, European Union, Saudi Arabia, and Latin America <br/>19. United States Medical Device Regulatory Framework <br/>Joshua Silverstein <br/>20. Regulation of Combination Products in the United States <br/>John Barlow Weiner and Thinh X. Nguyen <br/>21. European Union Medical Device Regulatory System <br/>Arkan Zwick and Gert Bos <br/>22. Regulation of Combination Products in the European Union <br/>Gert Bos <br/>23. Medical Device Regulatory Affairs in Latin America <br/>Carolina Cera and Gladys Servia <br/>24. Saudi Arabia: Medical Device Regulation System <br/>Ali Aldalaan <br/>Part 4: Medical Device Regulatory System in Asia-Pacific Region <br/>25. Australian Medical Device Regulations: An Overview <br/>Petahn McKenna <br/>26. China: Medical Device Regulatory System <br/>Jack Wong <br/>27. Hong Kong: Medical Device Regulatory System <br/>Jack Wong and Linda Chan <br/>28. India: Medical Device Regulatory System <br/>Kulwant S. Saini <br/>29. Indonesia: Medical Device Regulatory System <br/>Mita Rosalina <br/>30. Japan: Medical Device Regulatory System <br/>Atsushi Tamura and Keizo Matsukawa <br/>31. Korea: Medical Device Regulatory System <br/>Young Kim, Soo Kyeong Shin, and Jamie Noh <br/>32. Overview of Medical Device Regulation in Malaysia <br/>Ir. Sasikala Devi Thangavelu <br/>33. The Philippine Medical Device Regulatory System <br/>Rhoel Laderas <br/>34. Singapore Medical Device Regulation <br/>May Ng, Ray Soh, Trish, Beatrice, Bing Kang, Yiyu, Xinyu, Ivy Lim, and Tiffany Hu <br/>35. Taiwan: Medical Device Regulatory System Introduction <br/>Pei-Weng Tu <br/>36. Thailand: Medical Device Control and Regulation <br/>Kanokorn Pulsiri, Sirinmas Katchamart, Sansanee Pinthong, and Korrapat Trisansri <br/>37. Vietnam <br/>Nguyen Minh Tuan <br/>Part 5: Hot Topics <br/>38. A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company <br/>Jacky Devergne <br/>39. Regulatory Strategy: An Overview <br/>Pakhi Rusia <br/>40. Leading the New Normal by Accelerating Digital Transformation <br/>Virginia Chan <br/>41. An Overview of the Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development <br/>Jacob Cheong <br/>42. Overview of Health Supplements: Singapore <br/>Srilatha Sreepathy, Geeta Pradeep, and A. V. Rukmini <br/>43. International Medical Device School Experience <br/>Encey Yao <br/>44. Medtech Start-Up: Journey to First Product Approval <br/>Sing Wee, Joel Tan, and Trish, May Ng <br/>45. Digital Transformation of Healthcare and Venture Capital’s Role in It <br/>Mark Wang <br/>46. A Regulatory Career in Asia <br/>Ambrose Chan <br/>47. A Former FDA Investigator’s Views on Compliance with the Medical Device Regulations <br/>Ken Miles |
| 520 ## - SUMMARY, ETC. |
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| Summary, etc. |
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.<br/><br/>(https://www.routledge.com/Medical-Regulatory-Affairs-An-International-Handbook-for-Medical-Devices-and-Healthcare-Products/Wong-Tong/p/book/9789814877862?srsltid=AfmBOoplW7Yngyhn5vZ8nCP-7p7X7FcL_-vpZvvzub-24l1MmpRH9UNt) |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Medical device regulations |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical regulatory affairs |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical production and management--Handbook |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Wong, Jack [Edited] |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Tong, Raymond |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Book |
| Source of classification or shelving scheme |
Dewey Decimal Classification |
