GoingToMeet

In light of harmonization efforts in collaboration with ICH, the global guidelines for Stability Conditions were recently revised and modified, in particular the splitting of global stability regions earlier designated as Zone IV into Zone IVa and IVb. The regulatory authorities of the ASEAN countries, all considered hot and humid areas, have defined the harmonized requirements for stability testing on products intended to reach the ASEAN common market.

This live and comprehensive web seminar will cover the impact of these guidance revisions on global expectations for new and existing pharmaceutical ingredients, as well as address information to be submitted in original and subsequent applications for marketing authorization of their related pharmaceutical products for human use. In addition, a comparison of the regulatory expectations for different global regions will be presented, along with a model stability study that will span the requirements for all global areas.