Expert Medical Device, IVD and Combo Product Expert
The benefits of global regulators strengthening reliance and work-sharing initiatives worldwide is generally understood. Since the Global Harmonization Task Force, which ran from 1991 – 2011, harmonization efforts in pre-premarket and post-market have been a goal. These efforts were molded into more of a collaboration and reliance model with the expanded International Medical Device Regulators Forum (IMDRF) which took over in 2012 and continues today.
This session will take a look at the success of some of the IMDRF programs, such as MDSAP, SaMD, and Adverse Event Coding. The panelists will discuss current IMDRF initiatives and how industry can contribute. Lastly, the session will introduce “relianomics”, which can be defined as a structured framework for the assessment of the impact of regulatory reliance pathways on regulatory, economic, societal, and other systems. Industry representatives will opine on the shifting mindsets toward reliance and the importance of establishing clear KPIs to measure progress.
