25th Annual EuroMeeting

The purpose of this session is to consider the major trends and challenges driven by the new Quality Paradigm. The principles have been established by ICH Q8, Q9, Q10 and Q11. Some major regional training, Q&A and points to consider led to the clarification of how to implement this new concept, however in practical term, room for interpretation is still important creating a barrier to an easy implementation for regulatory submission. The next steps to consider will be to clarify some specific points such as: • How to consider the process validation in the context of the new paradigm • How to discuss and explain the critical aspect of the pharmaceutical development and where in the CTD document to provide the relevant information binding and no binding • The changes lead by the continuous improvement and how to address the change Control • The challenges and the opportunities offered by post-approval management Based on practical example the session will illustrate challenges and possible proposal around these questions.