IP Innovative Publication Pvt. Ltd.
IP Innovative Publication Pvt. Ltd.
The authors of "Text Book of Regulatory Affairs for the Students of M.Pharm 1st Semester" are Prof. (Dr.) Ravinesh Mishra, Dr. Bhartendu Sharma, Dr. Priya Sharma.
If you want to download the PDF of Text Book of Regulatory Affairs for the Students of M.Pharm 1st Semester, it is not allowed. However, you can immediately access the book by purchasing the ePub with a % discount.
If you want to download a Free PDF of Text Book of Regulatory Affairs for the Students of M.Pharm 1st Semester, it is not allowed. However, you can immediately access the book by purchasing the ePub with a % discount.
“Regulatory Affairs” presents a comprehensive exploration of the principles, practices, and evolving dimensions of pharmaceutical regulatory science. Developed to offer a balanced integration of theoretical foundations and practical applications, the book serves as an essential guide for understanding the global regulatory landscape that governs the development, evaluation, manufacturing, marketing, and post-marketing surveillance of pharmaceutical products. It systematically covers the regulatory frameworks of various national and international authorities, including detailed discussions on the roles and responsibilities of organizations such as the Central Drugs Standard Control Organization (CDSCO), United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and the International Council for Harmonisation (ICH). Special attention is given to the documentation and regulatory pathways required for new drug approvals, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Drug Master Files (DMF).
The book also delves into critical areas such as Intellectual Property Rights (IPR), patent filings, regulatory data protection, and exclusivity provisions, which are vital for innovation and commercial strategy in the pharmaceutical industry. Quality standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) are thoroughly explained, highlighting their significance in ensuring product safety, efficacy, and compliance. The design and ethical conduct of clinical trials, regulatory inspection processes, and pharmacovigilance systems for monitoring drug safety post-approval are also covered in detail. Supported by case studies, real-world examples, and regulatory updates, this book offers practical insights that reflect current industry trends and expectations. Its content is structured to encourage clarity, comprehension, and application, making it a reliable reference for anyone engaged in pharmaceutical development, compliance, or research. Whether used as a foundational resource or a practical manual, the Regulatory Affairs provides readers with the critical knowledge and skills necessary to navigate and succeed in the highly regulated and dynamic pharmaceutical environment.
Prof. (Dr.) Ravinesh Mishra is currently working as Dean, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. He holds a B. Pharm. from CCS University (2003), M. Pharm. from Rajiv Gandhi University of Health Sciences, Bengaluru (2007), and Ph.D. in Pharmaceutical Sciences from Jamia Hamdard University, New Delhi (2011). With over 18 years of professional experience, Prof. Mishra has qualified GATE twice and was awarded the UGC and CSIR fellowships during his doctoral studies. He received the prestigious DST Young Scientist Award in 2010 and has also undergone short-term toxicological trainings.
Prof. Mishra has made significant contributions to pharmaceutical research with over 80 publications, 14 patents, 3 books, and 10 book chapters to his credit. He has guided several M. Pharm students and Ph.D. scholars. His achievements have been recognized with awards from the Society of Toxicology and Therapeutic Drug Monitoring & Clinical Toxicology.
Dr. Bhartendu Sharma is currently working as an Associate Professor, Head of Department, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. He holds M.Pharm in Pharmaceutical Chemistry and earned his Ph.D. in Pharmaceutical Sciences, bringing with him over 13 years of academic and research experience. Dr. Sharma has been actively involved in both teaching and research, contributing to the development of future pharmaceutical professionals. His areas of interest include drug design and synthesis, medicinal chemistry, and pharmaceutical analysis. He has guided numerous undergraduate, postgraduate and Ph.D. scholars and is committed to fostering research-oriented learning. Over the years, he has contributed to several research publications in reputed journals and has participated in various national and international conferences. Dr. Sharma is dedicated to academic excellence, innovation in pharmaceutical education, and continuous professional development.
Dr. Priya Sharma is currently working as an Assistant Professor, School of Pharmacy and Emerging Sciences at Baddi University of Emerging Sciences and Technology, Baddi, Himachal Pradesh. She holds M.Pharm in Pharmaceutics and earned her Ph.D. in Pharmaceutical Sciences. With over 5 years of academic and research experience, she is actively involved in both teaching and guiding students in the field of pharmaceutical sciences. Her core areas of interest include novel drug delivery systems, formulation and development, and pharmaceutical technology. She has participated in several national/international conferences and workshops, and is committed to continuous learning and innovation in pharmaceutical education. Dr. Sharma has also contributed to research publications and is keen on expanding her research profile through interdisciplinary collaborations.
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