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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, as well as 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.
Veerareddy Prabhakar Reddy, Muralidhar Rao Akkaladevi
Dr. Prabhakar Reddy Veerareddy is the Principal at University College of Pharmaceutical Sciences, Palamuru University, Telangana. With a B.Pharm from Kakatiya University, an M.Pharm from Andhra University, a Ph.D. from Kakatiya University, and a Post-Doctoral Fellowship from Butler University, USA, he is a distinguished educator and researcher. Dr. Reddy has received numerous fellowships and awards, published two books, and holds one patent. He has an h-index of 28 with over 2200 citations. His research spans drug delivery systems and nanotechnology. Dr. Reddy is a member of several professional organizations and has delivered over 80 invited talks globally.
Dr. A. Muralidhar Rao is the distinguished Principal of St. Mary's College of Pharmacy and President of the Association of Pharmacy Professionals for Telangana State. With over 25 years of teaching experience, Dr. Rao has made significant contributions to pharmacy education and research. He is the author of 15 books on various pharmacy topics and has published numerous research papers.
Dr. Rao is a Fellow of the Association of Pharmacy Professionals (APP) and the Indian Science Congress Association (ISCA). He is also a life member of the Association of Pharmaceutical Teachers of India (APTI), the Indian Pharmacy Graduates' Association (IPGA), and the Indian Pharmacological Society (IPS). A respected speaker, he has presented at national and international conferences, sharing his expertise and inspiring others in the field
