Pharmaceutical Regulatory Affairs

Principles and Practices
1. Auflage 2025
ISBN: 978-1-032-94487-6
Verlag: Taylor & Francis Ltd

Buch, Englisch, 280 Seiten, Format (B × H): 210 mm x 280 mm

This book provides concepts, procedures, guidelines, and regulatory affairs in the drug development. It begins with a detailed overview of the drug development lifecycle, from initial discovery and preclinical research to clinical trials and market approval, addressing scientific, regulatory, and ethical considerations at each stage. The book covers the evolution of global trade agreements like GATT and the WTO's impact on pharmaceuticals, highlighting issues surrounding pharmaceutical patents and intellectual property rights. It discusses the importance of the SUPAC guidelines in ensuring quality and consistency in drug manufacturing post-approval and examines the WHO's guidelines on technology development and transfer. The fundamentals of regulatory affairs are covered, emphasizing the roles and responsibilities of regulatory professionals. The book provides an in-depth look at regulatory frameworks of major agencies worldwide, including the CDSCO in India, the FDA in the U.S., the EMA in the EU, the TGA in Australia, the PMDA in Japan, Health Canada, and regulatory authorities in emerging markets. It also addresses the international regulatory landscape for medical devices and reviews foundational pharmaceutical regulations. Additionally, it explores regulatory guidelines for clinical testing, including the roles and responsibilities under pharmaceutical legislation, principles of bioethics and biosafety, the digital transformation in clinical trials, and the critical role of pharmacovigilance. The book concludes with an examination of the global regulatory scenario for pharmaceutical excipients, providing a detailed roadmap through the complexities of drug development, regulatory compliance, and global standards. This book is valuable for professionals, researchers, and students of pharmaceutical sciences.

Zielgruppe

Professional Practice & Development and Professional Reference

Autoren/Hrsg.

Rajendran, Bharanitharan

Srivastava, Nimisha

Mishra, Neeraj

Ashique, Sumel

Fachgebiete

• Geisteswissenschaften Philosophie Angewandte Ethik & Soziale Verantwortung Wissenschaftsethik, Technikethik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Chapter1. Stages and Processes in Drug Development and Discovery. Chapter 2. The WTO and its Impact on Pharmaceuticals. Chapter 4. Pharmaceutical Patents and IPR. Chapter 5. Understanding the Scale-Up and Post-Approval Changes (SUPAC) Guidelines. Chapter 6. WHO Guidelines on Technology Development & Transfer. Chapter 7. Fundamentals of Regulatory Affairs in Pharmaceuticals. Chapter 8. Regulatory Framework of the Central Drugs Standard Control Organization (CDSCO) in India. Chapter 9. Regulatory Overview of the U.S Food and Drug Administration (FDA). Chapter 10. Regulatory Framework of the European Medicines Agency (EMA) and EU Member States. Chapter 11. Regulatory Processes of the Therapeutic Good Administration (TGA) in Australia. Chapter 12. Regulatory Landscape of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Chapter 13. Health Canada's Regulatory Framework for Pharmacueticals. Chapter 14. Regulatory Sciences in Emerging Markets of Rest of The World (Row). Chapter 15. International Regulatory Authorities for Medical Devices. Chapter 16. Regulatory Overview: Indian Drugs and Cosmetics Act of 1940 and Rules of 1945. Chapter 17. Responsibilities and Functions Under Pharmaceutical Legislation. Chapter 18. Principles of Bioethics and Biosafety in Pharmaceuticals. Chapter 19. Digital Transformation in Clinical Trials and Research. Chapter 20. Pharmacovigilance: Ensuring safety in clinical trials. Chapter 21. Regulatory Scenario of Excipients Worldwide. Chapter 22. Innovation through Renovation: Navigating Regulatory Framework and Technical Challenges of Drug Repositioning.

Über Autor(innen)

Nimisha Srivastava has been working as an Associate Professor at the Amity Institute of Pharmacy, Amity University Uttar Pradesh, Lucknow Campus since August 2008. She has over 16 years of teaching and research experience. She has more than 50 publications of international and national repute, focusing on novel drug delivery systems, dermatological disorders such as psoriasis, dermatitis, inflammation, and wound healing, as well as nano vesicular systems like ethosomes and transferosomes for herbal phytoconstituents, and nanocrystals for the treatment of breast and skin cancer. She was selected to present her innovation titled "Herbal Remedy for Psoriasis" at the Bio-Tech Startup Expo-2022 (BIRAC) Innovation towards Aatma Nirbhar Bharat on June 9, 2022, at Pragati Maidan, New Delhi. In 2019, she was awarded the Best Researcher Award for her work on "Herbal Remedies for Dermatological Disorders" by the Society of Biotechnologists of India.

Neeraj Mishra has been working as a Professor at Amity Institute of Pharmacy, Gwalior, since July 2019. He has around twenty years of teaching and research experience. He has more than 100 publications of international and national repute on recent concepts of novel drug delivery systems, oral delivery of synbiotics, localized drug delivery, and targeted and controlled drug delivery of nanocarriers and microparticles for the treatment of breast, colon, and neurodegenerative disorders. He has also edited 10 books and authored 25 book chapters. He has been granted three international patents and two Indian patents. Dr. Mishra is the recipient of the “Distinguished Professor Award” 2019 from DST-NSTMIS, SPAICS, Indore, and M.P. in September 2019. Dr. Mishra has also received the “Outstanding Scientist Award '' 2020, 6th International Scientist Awards on Engineering, Science, and Medicine, 20–21 June 2020, Chennai, India. He has received the “Distinguished Professor Award '' 2021 from the Indian Pharmaceutical Association, MP State Branch, Indore. Further, he has received the “Best Academician Award” in the Indian Pharmacy Graduate Association, M.P. State International Conference held on May 6, 2023, at DAVV Auditorium, Indore, India.

Sumel Ashique has been working as an Assistant Professor at the Pandaveswar School of Pharmacy in Pandaveswar, India. He has three years of teaching experience and has published more than 45 research articles in internationally and nationally accredited, reputed journals. He has been working in targeted drug delivery, nanotechnology, and infection disorders. He has also been granted four patents from IP and Australia and has authored more than 18 book chapters.

Bharanitharan Rajendran is an experienced professional with over a decade of dedicated expertise in the Life Sciences industry, specializing in Compliance, Quality Assurance, and Validation for GxP systems. His journey in this field spans from the earliest stages of Clinical Trials through to Post Market reporting, covering a wide spectrum of critical systems including Clinical Operations, Clinical Data Management, Regulatory Reporting, Safety & Adverse Event Reporting, Medical Affairs, Pharmacovigilance, Supply Chain, and ERP SAP systems. As a Certified Internal ISO27001 Auditor, Bharanitharan has a proven track record of successfully implementing Information Security Management Systems following ISO27001/ISO27002 standards.