About
the Book:
“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. |
About the Authors:
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.
Sandhya Mahendra Bagde is a known academician and
industry professional with a rich blend of 15 years of academic experience and
5 years of industrial expertise in the field of pharmaceutical sciences. Her
extensive knowledge and dedication have positioned her as a respected
authority, particularly in the domain of Pharmaceutical Regulatory Affairs. She
is conducting her doctoral research in Pharmaceutical Sciences, contributing
significantly to advancing knowledge in her field. Her research journey has
been marked by innovation and meticulousness, leading to numerous publications
in national and international journals of repute, which showcase her commitment
to scientific exploration and academic excellence. Throughout her career, she
has demonstrated exceptional proficiency in regulatory practices and
documentation, providing valuable insights into the complexities of the
pharmaceutical industry. Her industrial experience has further enriched her
teaching methodologies, enabling her to bridge the gap between theoretical
concepts and practical applications. As an educator, she has been instrumental
in guiding and mentoring students, instilling in them a strong foundation in
regulatory affairs and a keen understanding of the pharmaceutical landscape.
Her dedication to fostering excellence has inspired many aspiring professionals
in their academic and career pursuits.
Ketki Sunil Ande is a dedicated Quality Assurance
Sr. Officer at SUN PHARMA, one of India's leading pharmaceutical companies. She
specializes in dossier preparation and regulatory documentation, bringing a
wealth of practical experience to the field of Pharmaceutical Regulatory
Affairs. He has actively contributed to advancing knowledge in her domain
through the publication and presentation of her work in reputed national and
international journals and conferences. Her work highlights her commitment to
excellence in regulatory practices and her ability to navigate the complexities
of pharmaceutical regulations with precision. In her current role, He plays a
pivotal part in ensuring compliance with global regulatory standards, applying
her expertise to facilitate successful regulatory submissions. Her keen
understanding of documentation processes and attention to detail make her a
valued professional in the pharmaceutical industry. |
