Medical Product Regulatory Affairs - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Medical Product Regulatory Affairs write by John J. Tobin. This book was released on 2011-08-24. Medical Product Regulatory Affairs available in PDF, EPUB and Kindle. 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.
Medical Regulatory Affairs
Medical Regulatory Affairs - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Medical Regulatory Affairs write by Jack Wong. This book was released on 2022-01-27. Medical Regulatory Affairs available in PDF, EPUB and Kindle. 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.
Regulatory Affairs for Biomaterials and Medical Devices
Regulatory Affairs for Biomaterials and Medical Devices - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Regulatory Affairs for Biomaterials and Medical Devices write by Stephen F. Amato. This book was released on 2014-10-27. Regulatory Affairs for Biomaterials and Medical Devices available in PDF, EPUB and Kindle. 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
Medical Product Regulatory Affairs
Medical Product Regulatory Affairs - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Medical Product Regulatory Affairs write by John J. Tobin. This book was released on 2023-08-29. Medical Product Regulatory Affairs available in PDF, EPUB and Kindle. Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. 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. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
Handbook of Medical Device Regulatory Affairs in Asia
Handbook of Medical Device Regulatory Affairs in Asia - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Medical Device Regulatory Affairs in Asia write by Jack Wong. This book was released on 2013-03-27. Handbook of Medical Device Regulatory Affairs in Asia available in PDF, EPUB and Kindle. 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.
