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