Overview

Discover how to unlock efficient redaction and transparency processes in line with EMA policy 70 with Ideagen PleaseReview.

The EMA transparency policy 70 was suspended in 2018 as part of EMA's Business Continuity Plan for its relocation in the wake of Brexit. The suspension remained in effect throughout the COVID-19 pandemic apart from exceptional transparency measures for COVID-19 medicines. Now, nearly five years later, the policy has been re-launched.

While the transparency policy aims to enable public scrutiny and the application of new knowledge in future research, the policy stirs up challenges facing document review teams and organizations as a whole. Applicants are required to redact Personal Private Data (PPD), Personally Identifiable Data (PID) and Commercially Confidential Data (CCI) from their clinical data documents. The work on each of the different redaction types requires a different process and therefore needs to be take on by different teams, ideally in parallel as there is considerable time pressure.

Key takeaways

Join our insightful webinar "The road to transparency: mastering EMA policy 70 submissions" where we will delve into the implications of EMA transparency policy 70 and steps you can take to master efficient redactions and submissions.

Date and time: 29th February, 3pm BST

This webinar is hosted by James Wilding, VP of Collaboration Solutions at Ideagen.