Global Regulatory Inspections in Clinical Research: Preparation, Response, and Lessons Learned

This comprehensive guide explores the critical role of regulatory inspections in clinical research, offering a global perspective on the processes and expectations of key regulatory authorities. The book covers the history, mandates, and inspection methodologies of major bodies such as the FDA, EMA, MHRA, PMDA, Health Canada, TGA, SFDA, and DCGI, while highlighting common findings and strategies to address them effectively.

Readers will gain practical insights into preparing for inspections, managing noncompliance, and crafting robust Corrective and Preventive Action (CAPA) plans. Through detailed case studies and lessons learned, the book illustrates real-world scenarios and actionable strategies for sites, sponsors, and CROs to enhance their readiness and practices.

The book also delves into global trends, including the increased focus on electronic data, decentralized trials, and harmonization efforts under ICH-GCP. With a focus on quality systems and leveraging technology, it provides long-term strategies to maintain compliance and improve trial outcomes.

Ideal for clinical research professionals, this guide equips readers with the tools to navigate inspections confidently and uphold the highest standards in clinical research.