INTERNATIONAL COUNCIL FOR HARMONISATION
The ICH, established in 1990, has evolved to respond to the increasingly global face of drug development. Its mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Northeastern University’s Biopharmaceuticals Analysis Training Laboratory held a pilot program in Boston in October 2017 and has been an ICH Trusted Training Provider since November 2017. In addition to instructor-led training, online course material is being developed to reach an even broader audience.
Q1–STABILITY, 2.5-DAY TRAINING
1. Introduction to ICH and Stability Testing
2. Setting the scene
3. Specific expectations
Q8–Q11, 3-DAY TRAINING
1. History of the Quality Guidelines in ICH
2. Pharmaceutical Development: ICH-Q8(R2) part 1
3. Pharmaceutical Development: ICH-Q8(R2) part 2
4. Quality Risk Management: ICH-Q9
5. Pharmaceutical Quality Systems: ICH-Q10
6. Development and Manufacture of Drug Substance: ICH-Q11