WEBINAR: Navigating API Change Management in Japan

We recently held a webinar on the topic of change management in Japan. Teva api regulatory and change management experts, Marianna Kishinevsky and Rinat Bordman, discussed the change management landscape in Japan and how we, at Teva api, utilize our local, dedicated team in Japan to navigate the complex and frequent changes that require control and review.  

Watch the short webinar here below!

Marianna and Rinat outlined Teva api’s operations in Japan and all the supporting functions that contribute the right expertise in regulatory and change management. They explained where the changes come from – whether internally from Teva api’s manufacturing sites or from the PMDA authorities. They went into detail about the different types of major and minor changes that can and do occur and what’s needed from the team from the initial pre-notification of the change all the way through to submission. With major changes, there’s obviously a potential risk to the supply, so a lot more is needed to manage and deal with the change. Teva api’s special internal taskforce brings in all the relevant people to effectively manage the implementation of the change.  

They gave real and current examples of changes that were recently implemented in Japan and explained why changes occur in general. Marianna explained that changes are usually driven by the product strategy – to do with quality of the materials, changes of the supplier, procurement changes, cost reduction and so on. It’s an active industry where changes are a normal and natural occurrence.   

Lastly, they went into detail about how Teva api builds a resilient supply chain for change management and what’s needed to ensure minimum impact to the customer, making sure there’s clear communication and that the customer has enough stock until the change is fully implemented. Rather than having any external dependencies, we ensure that everything is controlled internally so that changes are easier to manage.