Safety Assessment of Borderline Products

10:40 AM - 11:05 AM

Regulatory preclinical safety assessment of medicinal products and medical devices generally requires a predefined set of in vitro and in vivo toxicity studies that are performed according to harmonized guidelines, such as those defined by ICH or ISO. However, some products fall outside the EU definitions of a medicinal product or medical device, and these therefore require a more customised approach to safety assessment. This presentation will focus on these non-standard products and the unique challenges they present.