Volume 2: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics

<p><b>Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics</b> by Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi is an essential resource for <b>M.Pharm B.Pharm students industry professionals</b> and <b>regulatory experts</b>. This book is meticulously structured into <b>20 comprehensive chapters</b> offering in-depth insights into critical areas of pharmaceutical regulatory affairs.</p><p>Key topics include the<b> clinical drug development process</b> with detailed coverage of phases from<b> Phase 0 to Phase IV</b> as well as <b>ethics in clinical research</b> exploring historical perspectives and modern ethical challenges. It also dives into <b>regulations governing clinical trials across major regions like India the USA the EU and Japan.</b></p><p>Readers will find valuable information on <b>USA Australian and European Union regulations</b> as well as <b>emerging markets such as ASEAN GCC and CIS countries</b>. The book also covers the <b>regulatory aspects of drugs cosmetics herbals biologicals medical devices and food and nutraceuticals</b>. Topics like <b>intellectual property rights (IPR) and quality management systems ensure readers are equipped with knowledge on patents data exclusivity and Total Quality Management.</b></p><p>This guide also examines future trends in pharmaceutical regulatory affairs offering insight into innovations and emerging regulatory practices. Ideal for professionals and students alike this book serves as a vital reference in the global regulatory landscape.</p>