Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners - Pise, Ajay G; Bagde, Sandhya m; Ande, Ketki s
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"Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners" is an exhaustive resource that aims to bridge the gap between academic curricula and industry requirements in the pharmaceutical domain. The book is carefully crafted to serve as a comprehensive guide for students, academicians, and professionals seeking to master the intricacies of regulatory writing and documentation practices. It provides a thorough understanding of the key aspects of documentation, including regulatory dossiers, SOPs, validation protocols, and clinical trial documentation, as well as…mehr

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Produktbeschreibung
"Documentation and Pharmaceutical Regulatory Writing for Students and Practitioners" is an exhaustive resource that aims to bridge the gap between academic curricula and industry requirements in the pharmaceutical domain. The book is carefully crafted to serve as a comprehensive guide for students, academicians, and professionals seeking to master the intricacies of regulatory writing and documentation practices. It provides a thorough understanding of the key aspects of documentation, including regulatory dossiers, SOPs, validation protocols, and clinical trial documentation, as well as international regulatory guidelines from the FDA, EMA, and ICH. The book also places special emphasis on practical aspects, incorporating real-world examples, case studies, and checklists to provide a hands-on learning experience and facilitate application in professional scenarios.
Autorenporträt
Ajay Ghanshyamji Pise is a distinguished professor and invertor in the field of pharmaceutical sciences, with over a decade of experience in research, education, and innovation. He holds 10 National-International awards including the Best Teacher Award from MCOPS, Manipal University. He has presented his research work in more than 15 countries, including Singapore, Malaysia, Sri Lanka, the Netherlands, and Dubai. He has served as BOS member of RTM Nagpur University and Manipal University. As an academic mentor, He has guided over 200 individuals in starting their own ventures in Vidarbha, fostering a culture of entrepreneurship and innovation. His leadership extends to the Lifon Group, an initiative supporting farmers and unemployed youth, and his revolutionary sandalwood farming project in Chimur Vidhan Sabha, where he actively promotes the economic importance of sustainable farming practices. He has authored multiple books, published research papers in reputed International Journals, and holds patents that underscore his dedication to pharmaceutical innovation. As the founder of Lifon Healthcare, he has also pioneered the production of health drinks and natural products, leveraging traditional knowledge and modern science to promote health and well-being. His expertise and vision make him a respected figure in the pharmaceutical and healthcare industries.