Medical Devices (includes In Vitro Diagnostics)
The use of companion diagnostics (CDx) has become increasingly common in recent years due to advances in diagnostics and therapies related to oncology, inflammation and autoimmune diseases. Coupled with the benefit of customizing treatment options for individual patients, assuring positive outcomes and avoiding side effects, CDx offer a revolutionary approach to improving patient care. However, the need to have both the drug and device approved for market at the same time and the unique regulatory requirements adds to the complexity of the co-development process. Successful launch of CDx products relies on regulatory professionals who can navigate the challenges exclusive to CDx.
A successful companion diagnostics launch relies on the ability of the regulatory professionals to navigate the challenges unique to CDx products. Even though the regulatory requirements for developing companion diagnostics are outlined by the US Food and Drug Administration (FDA) and other regulatory authorities each drug-device combination is distinctive as are the associated challenges. The session is designed to provide participants with an in-depth perspective of the important issues faced by regulatory professionals and practical regulatory solutions for working in the CDx space.