Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics and complementary medicines.
Companies responsible for the discovery, testing, manufacture and marketing of these products must ensure sale of safe and effective products. Drug Regulatory Affairs refers to fulfilment of all aspects of drug regulations within the pharmaceutical companies from development process to finished product marketing.
The book provides a sound basis on understanding of international drug regulatory guidelines controlling the quality, safety and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in pharmaceutical industry.
|Publishers||CBS Publishers & Distributors|
|Size||28×40/16 (trimmed 173×240mm)|
|About the Author||
Papiya Bigoniya MPharm, PhD is currently Professor and Principal, DSKM College of Pharmacy, RKDF University, Bhopal. Earlier, she served as faculty at Department of Pharmacy, Barkatullah University, Globus College of Pharmacy, Bhopal, and Professor and Principal, Radharaman College of Pharmacy, Bhopal.
She completed her BPharm from Dr HS Gour University, Sagar, MPharm from Jadavpur University, Kolkata, and PhD from Dr HS Gour University, Sagar. She has to her credit 109 national and international publications in peer-reviewed journals, contributed in 10 book series and presented more than 98 papers at various conferences, workshops, seminars, SDPs and training programs.
Dr Bigoniya has 21 years of experience in research and teaching. She is the editorial board member, reviewer and referee in a number of journal. She has an Indian patent approved for innovation in skin cancer therapy, and working experience as principal investigator in research projects sponsored by various bodies like UGC, AICTE, MPCST and DRDO.