CMC Workshop

This session will provide an overview and update about the regulatory landscape in the Middle East, with main focus on challenges and opportunities. It will reflect the updated accelerated programs implemented recently in the region and sharing successful stories. It will address as well the current post-approval CMC changes model, the specificity of the local requirement linked to the complex supply management and patient access implication, with an industry proposal for future trend to optimize the life cycle maintenance activity of the registered products.