Stability Testing of New Drug Substances and Products Q1A (R2)

Tuesday, 26th October, 2021, 11:00 AM - 12:00 PM CEST.

Stability testing of New Drug Substances and Products according to the guideline ICH Q1A (R2) which addresses the information to be submitted in registration applications for new molecular entities and associated drug products. Topics as shelf life, storage conditions, climatic zones, stress testing, long term testing, intermediate testing and accelerated testing are considered and the content of the guideline is examined.