ICH guidline training

the National Agency for pharmaceutical products has organized on April,18th,2024 a training session led by internationally specialized trainers on the technical requirements for the registration of pharmaceutical products for human use ICH.

This session was dedicated to the agency’s executives and evaluators, focused on the quality of biological products. The main theme of this training was the ICH Q5E guideline, highlighting the comparability of biotechnology and biological products, particularly in the case where modifications are made to the manufacturing processes.