Clinical/Regulatory Engagement


To date, InSilc has been completed interaction with regulatory bodies and clinical trial forums through attending various events that have provided networking opportunities, while also taking part in targeted one-on-one meetings with notified bodies, regulatory experts and clinicians. Several notable engagements have taken place, including several one-on-one meetings with Dr. Robert Bryne, who is a key opinion leader in the field of Cardiovascular Interventions and leader of the European Association of Percutaneous Cardiovascular Interventions Task force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention. Furthermore, there has been significant clustering activity with other projects, with InSilc involved in a recent closed-door meeting to discuss regulatory issues related to In Silico Clinical Trials organised by Prof. Viceconti. This engagement and activity is ongoing, where the ultimate aim is to develop a regulatory strategy for InSilico Medicine to fill the gap in the current regulatory landscape.