ICH Guidelines & Harmonization

About This Course

Understand the international standards that make global drug development possible. ICH guidelines are the foundation of pharmaceutical regulation across the US, EU, and Japan, and this course shows you how to use them effectively. You'll learn how these harmonized guidelines save time and money by allowing you to use the same data and documentation in multiple regions. We cover all the major guideline categories—quality, safety, efficacy, and multidisciplinary—and show you how they apply to your daily work. Whether you're developing a new product or working on regulatory submissions, understanding ICH guidelines helps you make better decisions and avoid rework. This course explains not just what the guidelines say, but how to interpret and apply them in real-world situations, so you can develop products that meet international standards from the start.