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.
INTERNATIONAL COUNCIL FOR HARMONISATION
Q1–STABILITY, 2.5-DAY TRAINING
1. Introduction to ICH and Stability Testing
2. Setting the scene
3. Specific expectations
Past offering: March 10-12, 2020, Burlington, MA USA
Dates for additional offerings TBC.
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
2020 Dates TBC