Medical Regulatory Affairs
DOWNLOAD
Download Medical Regulatory Affairs PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Medical Regulatory Affairs book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Medical Regulatory Affairs
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2022-01-27
Medical Regulatory Affairs written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-27 with Medical categories.
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
DOWNLOAD
Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-24
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-24 with Science categories.
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.
Handbook Of Medical Device Regulatory Affairs In Asia
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.
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
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2018-03-28
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
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.
Review On Pharmaceutical Regulatory Affairs
DOWNLOAD
Author : Ilamathi.A.S
language : en
Publisher: Writers Corner Publication
Release Date : 2024-04-03
Review On Pharmaceutical Regulatory Affairs written by Ilamathi.A.S and has been published by Writers Corner Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-03 with Antiques & Collectibles categories.
ABSTRACT: Regulatory affairs in the pharmaceutical industry play an important role in ensuring the safety, efficacy, and quality of medicinal products worldwide. The pharmaceutical drug regulatory affairs profession was developed from the desire all over the world to protect public health by providing good quality medicine including safety and efficacy in the area of not only pharmacy but also in the area of veterinary medicine, medical devices, insecticides, pesticides, agrochemical, cosmetic and complementary medicine. Regulatory affairs acts as an interface between the pharmaceutical company and the regulatory agencies. The key role of regulatory affairs professions includes maintaining Compliance, Product approval, Risk management, Market access, Quality assurance. It works under proper organizational structure and various regulatory bodies around the world. Regulatory affairs professional also involves in clinical trail and R&D to develop innovative products that take advantage of new technological and regulatory developments to accelerate time to market. They can face regulatory non-compliance issues, but drug developers can also look to tech-enabled solutions to improve regulatory compliance. Regulatory affairs should explore whether the different innovation in pharma can decrease the risk of compliance issues.
Handbook Of Medical Device Regulatory Affairs In Asia
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2018-03-28
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
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 Device Regulatory Practices
DOWNLOAD
Author : Val Theisz
language : en
Publisher: CRC Press
Release Date : 2015-08-03
Medical Device Regulatory Practices written by Val Theisz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-03 with Medical categories.
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 effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Medical Product Regulatory Affairs
DOWNLOAD
Author : Dr. John J. Tobin
language : en
Publisher:
Release Date : 2024
Medical Product Regulatory Affairs written by Dr. John J. Tobin and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024 with Drugs categories.
Combination Products
DOWNLOAD
Author : Smita Gopalaswamy
language : en
Publisher: CRC Press
Release Date : 2008-04-22
Combination Products written by Smita Gopalaswamy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-22 with Business & Economics categories.
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
Fda Regulatory Affairs
DOWNLOAD
Author : David Mantus
language : en
Publisher: CRC Press
Release Date : 2014-02-28
Fda Regulatory Affairs written by David Mantus and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-28 with Medical categories.
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.