Medical Affairs in the Healthcare 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 Medical Affairs in the Healthcare Industry write by Dr Peter Kruse. This book was released on 2015-12-03. Medical Affairs in the Healthcare Industry available in PDF, EPUB and Kindle. Peter Kruse MD, PhD, has divided a nearly 30 year professional career as a physician, scientist and working for the healthcare industry for global drug, biologics and medical device companies. This introduction to Medical Affairs gives a quick overview of this unique role that provides "the bridge" between Science and Business. Dr. Kruse shares his experience and some tricks of the trade - easy and to the point - for anyone working already in the Medical Affairs field or wishes to join it.
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.
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.
Medicine and Culture
Medicine and Culture - 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 Medicine and Culture write by Lynn Payer. This book was released on 1996-11-15. Medicine and Culture available in PDF, EPUB and Kindle. The author concludes that medical decisions are often based on cultural biases and philosophies, suggesting a revaluation of American medical practices is warranted.
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
