The Modern Regulatory Era: AI, Regulatory Intelligence, Global Harmonization, and Risk-Based Transformation in Pharmaceutical Development
Abstract
The Modern Regulatory Era: AI, Regulatory Intelligence, Global Harmonization, and Risk-Based Transformation in Pharmaceutical Development Table of Contents CHAPTER 1 IntroductionCHAPTER 2 Foundations of Pharmaceutical Law and GovernanceCHAPTER 3 The Architecture of Global HarmonizationCHAPTER 4 Principles of Risk-Based RegulationCHAPTER 5 Regulatory Intelligence FrameworksCHAPTER 6 Data Standards and Electronic SubmissionsCHAPTER 7 Preclinical Development and Translational PathwaysCHAPTER 8 Clinical Trial Design and Adaptive ProtocolsCHAPTER 9 Chemistry, Manufacturing, and Controls and Quality by DesignCHAPTER 10 Expedited and Accelerated Approval MechanismsCHAPTER 11 Artificial Intelligence in Drug Discovery and DesignCHAPTER 12 Artificial Intelligence in Clinical Trials and OperationsCHAPTER 13 Real-World Data and Real-World EvidenceCHAPTER 14 Automated Regulatory Intelligence and Dossier GenerationCHAPTER 15 Biosimilars, Biologics, and Advanced TherapiesCHAPTER 16 Digital Health, Medical Software, and ConvergenceCHAPTER 17 Pharmacovigilance and Post-Market Lifecycle ManagementCHAPTER 18 Global Health Authority Inspections and Compliance AuditsCHAPTER 19 Comparative Regulatory Case StudiesCHAPTER 20 Strategic Horizons and Concluding Synthesis