Medical Regulatory Affairs
Title | Medical Regulatory Affairs PDF eBook |
Author | Jack Wong |
Publisher | CRC Press |
Pages | 806 |
Release | 2022-01-27 |
Genre | Medical |
ISBN | 1000440516 |
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.
Medical Product Regulatory Affairs
Title | Medical Product Regulatory Affairs PDF eBook |
Author | John J. Tobin |
Publisher | John Wiley & Sons |
Pages | 304 |
Release | 2011-08-24 |
Genre | Science |
ISBN | 3527644717 |
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Regulatory Affairs for Biomaterials and Medical Devices
Title | Regulatory Affairs for Biomaterials and Medical Devices PDF eBook |
Author | Stephen F. Amato |
Publisher | Elsevier |
Pages | 203 |
Release | 2014-10-27 |
Genre | Technology & Engineering |
ISBN | 0857099205 |
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Handbook of Medical Device Regulatory Affairs in Asia
Title | Handbook of Medical Device Regulatory Affairs in Asia PDF eBook |
Author | Jack Wong |
Publisher | CRC Press |
Pages | 618 |
Release | 2013-03-27 |
Genre | Medical |
ISBN | 9814411213 |
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Handbook of Medical Device Regulatory Affairs in Asia
Title | Handbook of Medical Device Regulatory Affairs in Asia PDF eBook |
Author | Jack Wong |
Publisher | CRC Press |
Pages | 475 |
Release | 2018-03-28 |
Genre | Medical |
ISBN | 0429996764 |
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Medical Product Regulatory Affairs
Title | Medical Product Regulatory Affairs PDF eBook |
Author | Dr. John J. Tobin |
Publisher | |
Pages | 0 |
Release | 2024 |
Genre | Drugs |
ISBN | 9783527688999 |
Medical Device Regulatory Practices
Title | Medical Device Regulatory Practices PDF eBook |
Author | Val Theisz |
Publisher | CRC Press |
Pages | 578 |
Release | 2015-08-03 |
Genre | Medical |
ISBN | 9814669113 |
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv