الصفحة 1
الصفحة 1
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices
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.
Career options in the pharmaceutical and biomedical industry : An insider’s guide
Divided into five parts: Part 1 provides an academic perspective that focuses on the specific preparation required in the final years of study to embark on a successful career in the pharmaceutical and biomedical industries. In Part 2, industry experts discuss employment possibilities all along the drug or product life cycle,from discovery research and development to commercialisation. Part 3 follows, highlighting opportunities in support functions such as regulatory affairs or quality assurance. Part 4 focuses on additional opportunities in the wider biomedical sector, while Part 5 contains practical tips and training opportunities for entering the pharmaceutical and biomedical industries. In the epilogue, the authors reflect on this fascinating field and its career prospects.
Advances in pharma business management and research ; Vol. 1
This book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'.
