Transforming Computational Modeling from A Valuable Scientific Tool to A Valuable Regulatory Tool: Myth or Reality?
Healthcare companies have been investing in computer modeling and simulation (i.e., in silico) methods for decades to accelerate the innovation of safer and more robust products. Over the past few years, FDA has established various regulatory frameworks that accommodate the incorporation of in silico (digital) evidence in device submissions. Their efforts include the publication of guidance documents, collaboration with medical device industry stakeholders to develop the ASME V&V 40 standard, and collaboration with international organizations.
ANSYS, US FDA, and the Avicenna Alliance are organizing a roundtable discussion focusing on modeling and simulation in the medical device and pharmaceutical industries. The goal of the meeting is to discuss opportunities and challenges when utilizing in silico approaches during development and regulatory review. The event will be organized around 2 panel discussions, where senior leaders from the largest medical device and pharmaceutical companies will be sharing their experience and expectations.More information can be found here