How to design pre-clinical combined studies evaluating both long term systemic toxicity and local tissue effects

The risks of long term systemic effects according to ISO 10993-11 and local effects after implantation according to ISO 10993-6 should be addressed for all implantable medical devices. In order to reduce the number of animals used, for a more ethical use of animals according to the three Rs, it is possible to combine these evaluations. Nevertheless, when conducting combined studies for evaluating local effects and systemic effects, one should pay attention to fulfill the requirements of both standards. The webinar aims to provide an overview of the regulatory requirements related to those evaluations and give inputs for the pre-clinical study designs through the use of case studies.