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.
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 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.
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 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 in the Pharmaceutical Industry
Regulatory Affairs in the Pharmaceutical Industry - 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 in the Pharmaceutical Industry write by Javed Ali. This book was released on 2021-11-14. Regulatory Affairs in the Pharmaceutical Industry available in PDF, EPUB and Kindle. Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
