The Evolution of Policy 0070: EMA Clinical Data Publication

Industry has significant experience with use of redaction in delivery of Redacted Clinical Packages and the use of the qualitative risk assessment approach. To drive better clinical utility, we must find tools that support use of additional anonymisation techniques and the ability to measure the risk associated with a submission that can support scalable delivery of Redacted Clinical Packages. In this session we will seek examples of potential tools which have been developed by vendors to measure risk and/or anonymise beyond redaction. The sessions are designed to ask vendors to demonstrate how their tool goes beyond redaction and supports risk assessment in the anonymisation of clinical documents. The session is designed to allow participants a chance to see all potential tools and seek potential solutions for their companies. This session will focus on tools, not services.