Global CMC Requirements covering the Product Lifecycle - Quality data for non-EU and management of company's global CMC interfaces

The focus of this seminar is on CMC requirements in non-EU countries. Another key topic is the question on how to continuously secure regulatory compliance along the international interfaces.

Our experts will pass on their in-depth knowledge of standards especially for the Brazilian, Chinese, Russian and Japanes markets. They will share their experience on international variation management and give you an insight into the world of GMP. During the workshop you will have the opportunity to discuss and share your compliance issues and find personal solutions.


After attending the seminar, you will have a profound understanding of your CMC duties within the international pharmaceutical environment covering both: concrete content related topics and managerial interactivities at the interfaces: Thereby improving your skills to work towards the expectations of your interfaces.