Pharmaceutical Regulatory Affairs : Principles and Practices (Hardcover)

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.