Книга "Medical Product Regulatory Affairs" является наиболее обширным исследованием в своей области и охватывает вопросы регулирования медицинских изделий и лекарственных средств во всех основных мировых рынках. Автор предоставляет ясное и лаконичное описание материала, основанное на многолетнем опыте работы в данной области. В книге рассматриваются вопросы разработки лекарственных средств, а также национальные и европейские вопросы регулирования, получение и сохранение лицензий на производство, а также регулирование в США. Кроме того, в книге также рассматриваются вопросы, связанные с CDER, CBER, получением маркетинговых и производственных лицензий, процессом ICH и хорошими лабораторными, клиническими и производственными практиками. Эта книга станет незаменимым ресурсом для фармакологов, биоинженеров, фармацевтов и студентов фармацевтических факультетов, а также для всех, кто работает в фармацевтической индустрии и нуждается в знаниях в области регулирования медицинских изделий.
Written in a lucid and succinct style by a seasoned author, this competitively priced text covers regulatory issues in all the major global markets regulating pharmaceuticals and devices, and as such is by far the most complete text in its field of reference. Starting from medicine development, there are full sections devoted to the regulation applicable in various national and EU countries, applying and maintaining a manufacture's licence, regulation in the United States of America, among others, matters such as marketing and production licenses, Good Laboratory Practices and the extensive International Cooperation in the Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) process, to mention but a few topics relevant to pharmacologists and bioengineers amongst others. Every pharmacist, biomedical engineer, pharmaceutical process engineer or student of pharmacy with an interest in the challenges posed to the pharmaceutical sector by regulation would benefit from familiarising themselves with this authoritative guide to medical regulatory matters.
This is an interesting book just because of its price category. Although it appears at first wholly dedicated to drug development and regulation, it's actually quite comprehensive, covering all the regulatory maerks across the globe, as well as in the EU, in the United States of America and complete sections on marketing, license and production. It also deals with how to work with the good laboratory practices too.
Электронная Книга «Medical Product Regulatory Affairs» написана автором Gary Walsh в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9783527623044
Описание книги от Gary Walsh
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.
