Medical Product Regulatory Affairs 在線電子書 圖書標籤:
發表於2025-01-11
Medical Product Regulatory Affairs 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2025
"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." –Microbiology Today, May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and 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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
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Medical Product Regulatory Affairs 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2025