Combined products: regulations & clinical development

2:55 PM - 3:25 PM

Despite the development and increasing use of products combining medicinal products, medical devices and digital health technologies (combined products), there is no harmonised regulatory framework for these products globally. The session will discuss challenges in navigating regulatory pathways in various regions and how to bridge the gap between the medicinal products and the medical devices frameworks. The development of combined products challenges organisations and requires new collaboration models within companies and between pharmaceutical companies and device manufacturers. This session will also discuss clinical development of combined products and data generation and what role medical writers may play in this process.