The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an interactive review session and share learnings between sponsors to advance the understanding of fit-for-purpose RWD to generate RWE.
Be on the look out for our newest publication! The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency
Active Open Hand Working Group members represent the following IVD stakeholders: