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A Concise Textbook of Drug Regulatory Affairs Paperback – 2015
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About the Book This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. About the Editors Dr N Udupa, born in July 1953, completed his post-graduation in 1976, received PhD from Banaras Hindu University, Varanasi in 1987. After serving in Pharma Industry for eight years, he has been working in academics for last 30 years. He currently holds the position of Director Research – Health Sciences, Manipal University, Manipal and served as Principal of Manipal College of Pharmaceutical Sciences, Manipal University, Manipal from 1997-2013. He received Principal of the Year (2001) award from APTI. He served as Convener - Scientific Services of Indian Pharmaceutical Congress Association from 2010 to 2012. Dr Krishnamurthy Bhat completed his graduation and post-graduation in Pharmacy from JSS College of Pharmacy, Mysore and L M College of Pharmacy, Ahmedabad respectively. He received his PhD from Gujarat University. Dr Bhat worked with Bangalore Pharmaceutical and Research Laboratory, Bangalore as Manager – Quality Assurance. He has worked as a faculty in K B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat. Dr Bhat was instrumental in establishing bioanalytical section of Manipal Acunova. Currently, he is Professor and Head, Department of Pharmaceutical Quality Assurance at Manipal College of Pharmaceutical Sciences, Manipal University.
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