Academic Publication

Author Profile

Kavita Bahmani, M.Pharm, Ph.D is Assistant Professor in Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science & Technology, Hisar, Haryana, India. She is actively involved in many academic organizations. She established herself as good teacher and researcher. She has published and presented many research papers in National and International journals. Dr. Kavita Bahmani has also authored many two professional books. She is life member of pharmaceutical societies involved in professional organizations. She has attended many conferences & seminars. She is awarded with National Education award for the contribution in education. By online platforms viz. Youtube and slide share she share lots of lectures and presentations with the students. Dr. Neelam Pawar is working as Assistance Professor in Chaudhary Bansilal Universitiy, Bhiwani, Haryana. Dr. Neelam Pawar has undergone training and internships to enhance her knowledge and expertise in the pharmaceutical field. Dr. Neelam Pawar has published several research papers in reputed journals and has authored book chapters in the field of pharmaceutical regulatory science and social research methodology. Her guidance has led to valuable contributions to the field. She has also authored a book titled “Pharmaceutical Regulatory Science,” which contributes to the understanding of regulatory requirements in the pharmaceutical industry. Apart from her academic and research endeavors, Dr. Neelam Pawar has participated in various seminars, webinars, and conferences, sharing her knowledge and insights with the global pharmaceutical community. She has also been a part of several national and international events related to drug development, healthcare, and academic advancements.

About The Book

"Regulatory Aspects of Herbal and Biologicals" is a comprehensive and enlightening exploration that navigates the intricate intersections of traditional wisdom and modern regulatory frameworks within the realm of herbal and biological products. In a world constantly shaped by scientific breakthroughs, this book unravels the complexities of regulations governing these dynamic domains, spanning geographical boundaries to encompass India, the United States, and the European Union. At its core, this book empowers readers with fundamental insights into the regulatory landscapes surrounding biologics and vaccines. Delving deep into the intricacies, it unravels the multifaceted requirements governing newly developed biologics and their biosimilars, shedding light on the intricate processes of preclinical and clinical development. The exploration extends to the realm of blood and its components, elucidating the crucial significance of regulatory compliance in healthcare. Each chapter offers a unique vantage point on regulatory frameworks. From India's foundational principles to the United States' nuanced biologics landscape, and the European Union's intricate directives, the book unveils the intricacies of each region's regulatory tapestry. The investigation extends to the global realm of vaccines, delving into clinical evaluation, marketing authorization, quality assessment, and pharmacovigilance. Completing the journey, the book illuminates the realm of herbal products, dissecting quality, safety, and legislative considerations across continents. Through its pages, readers embark on an enriching educational odyssey, gaining a panoramic view of the regulatory landscapes that underpin the health and wellbeing of our global community.

Table of Contents

Preface Unit I Introduction 1.1 How Do Biological Products Differ From Conventional Drugs? 2. Applicable Regulations and Guidelines in India 3. Development Principle for Similar Biologics 4. Data Requirements (Preclinical Studies) 5. Clinical Trial Application (Data Requirements) 6. Market Authorization Application Data Requirements 7. Postmarket Data 8. Pharmacovigilance 9. Good Manufacturing Practice 10. Good Distribution Practices Review Questions Unit II Biological Products 1.1 Biosimilars 2. Biologics Regulations Laws 3. Guidance and Regulation on Biosimilars 4. Approval of Biosimilar Product 5. General Requirement 6. Biological License Application (BLA) Biologics Licensing Review Questions Unit III Introduction of Biologics 2. Directives 3. Scientific Guidelines and Guidance of Europe 4. Comparability and Biosimilarity 5. Guidelines 6. Marketing Authorization Application 7. Plasma Master File (PMF) 8. Requirements for Initial Application for Certification 9. Regulatory Frame Work 10. Regulation in EU 11. Development of Biologics 12. Clinical Trial Authorization 13. Safety of Biosimilars 14. Advertisements 15. Labelling Review Questions Unit IV Introduction 2. United States Vaccine Regulation 3. Vaccines Regulation in European Union 4. Blood And Bloodrelated Products Part Xii B: Requirements for the Functioning and Operation of A Blood Bank and / or for Preparation of Blood Components 5. European Union Regulation 6. International Society of Blood Transfusion (ISBT) 7. International Haemovigilence Network (INH) Review Questions Unit V Herbal Products 6. Legal Provisions /regulations For ASU &H Drugs 7. Main Regulatory Bodies Part 1general Requirements Schedule Y for Herbal Medicine Review Questions