{"product_id":"volume-2-comprehensive-guide-to-pharmaceutical-regulatory-affairs-global-regulations-and-advanced-topics-9798895567074","title":"Volume 2: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics","description":"\u003cp\u003e • Author(s): Veerareddy Prabhakar Reddy | Muralidhar Rao Akkaladevi\u003cbr\u003e • Publisher: Notion Press\u003cbr\u003e • Publisher Imprint: Notion Press\u003cbr\u003e • BISAC: Research\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eComprehensive Guide to Pharmaceutical Regulatory Affairs: Global Regulations and Advanced Topics\u003c\/strong\u003e by Veerareddy Prabhakar Reddy and Muralidhar Rao Akkaladevi is an essential resource for \u003cstrong\u003eM.Pharm, B.Pharm students, industry professionals\u003c\/strong\u003e, and \u003cstrong\u003eregulatory experts\u003c\/strong\u003e. This book is meticulously structured into \u003cstrong\u003e20 comprehensive chapters\u003c\/strong\u003e, offering in-depth insights into critical areas of pharmaceutical regulatory affairs.\u003c\/p\u003e\u003cp\u003eKey topics include the\u003cstrong\u003e clinical drug development process\u003c\/strong\u003e, with detailed coverage of phases from\u003cstrong\u003e Phase 0 to Phase IV\u003c\/strong\u003e, as well as \u003cstrong\u003eethics in clinical research\u003c\/strong\u003e, exploring historical perspectives and modern ethical challenges. It also dives into \u003cstrong\u003eregulations governing clinical trials across major regions like India, the USA, the EU, and Japan.\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eReaders will find valuable information on \u003cstrong\u003eUSA, Australian, and European Union regulations\u003c\/strong\u003e, as well as \u003cstrong\u003eemerging markets such as ASEAN, GCC, and CIS countries\u003c\/strong\u003e. The book also covers the \u003cstrong\u003eregulatory aspects of drugs, cosmetics, herbals, biologicals, medical devices, and food and nutraceuticals\u003c\/strong\u003e. Topics like \u003cstrong\u003eintellectual property rights (IPR) and quality management systems ensure readers are equipped with knowledge on patents, data exclusivity, and Total Quality Management.\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eThis 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.\u003c\/p\u003e","brand":"Atlantic Books","offers":[{"title":"Paperback","offer_id":46384056008855,"sku":"9798895567074","price":2753.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9798895567074.webp?v=1768781749","url":"https:\/\/atlanticbooks.com\/products\/volume-2-comprehensive-guide-to-pharmaceutical-regulatory-affairs-global-regulations-and-advanced-topics-9798895567074","provider":"Atlantic Books","version":"1.0","type":"link"}