Outsourcing of a clinical development program

Two years ago we outsourced the clinical development program of a product to an external organization. We expect the submission of the NDA next year. Our plan is to develop the product further in-house and develop it for new indications. We have to monitor the safety of this product very carefully across phases and indications. What is needed to be ready for this task?

Pre-registration and post-registration safety

In our company pre-registration and post-registration safety is the responsibility of two departments. We want to implement a sustainable approach for the monitoring of product’s safety. Reorganization is not an option. Please evaluate the situation and propose solutions.

Safety crisis-like situation

Last year we had a safety crisis-like situation with one of our marketed products. We made substantial efforts to understand what happened. The causes of the problem were identified and a plan was set up to eliminate them. In the future we want to identify critical signals earlier. How can we do this?

Country specific and global development

We (a Japan based company) have signed a licensing agreement with a Europe based pharma company. The agreement gives the licensee the right to develop and commercialize one of our promising products globally, except in Japan. The product was recently introduced in Japan. We will monitor the safety of our product in the Japanese market. Do we have any other legal or regulatory obligation with regard to safety? Are there any other critical issues we may not have considered?