Avoiding Policy 0070 Pitfalls and Ensuring Compliance

Email this to someonePrint this pageShare on LinkedIn0Tweet about this on TwitterShare on Google+0

Avoiding Policy 0070 Pitfalls case study

The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since then has undergone several iterations. The evolving guidance adds complexities to the Marketing Authorisation Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness and greater data utility, many aspects of the disclosure process remain undefined, leaving sponsors to work through complex issues on their own. Further updates are expected as the EMA incorporates additional requirements such as advanced anonymization techniques and dataset de-identification. Avoiding Policy 0070 pitfalls, ensuring compliance, and keeping teams engaged within the changing paradigm is challenging but critical to success.

CASE STUDY: “The Bear, The Alligator, and the Sloth”

Synchrogenix Redaction Management Solutions

Synchrogenix offers expert guidance and our ClinGenuity Redaction Management Service (CRMS™), the industries only AI-enabled technology solution for redaction ensuring consistent and compliant redaction packages…
  • 5+ years of redaction experience with over 5,500 reports
  • 15+ applications already published, 45+ in process using Synchrogenix’s anonymization methodology
  • Leverage our experience across the largest Tier 1-3 sponsor partners in the industry
  • Over 10 million pages processed

Author: Synchrogenix

Share This Post On
%d bloggers like this: