EMA (Policy 0070) Re-launch
Key date: September 2023
Key Emphasis Points from re-launch Webinar
• Early preparation of packages for submission – prior to Opinion
• Complete QC check prior to submission
• CCI redactions shall be checked and justified properly
How can GENINVO help you with anonymization?
• Experienced team of SMEs to support you with setting up process to meet Policy 0070 requirements.
• Industry leader In-house developed automation tool for anonymization i.e., SHADOW
• License and perform anonymization in-house or Outsource to our team of SMEs.
What is Shadow?
• 21 CFR 11 and GDPR compliant solution to support Data + Document + DICOM image anonymization
• Automated to reduce more than 50% time for anonymization
• Established success for EMA 0070 and Health Canada PRCI submissions
Our Experience
• Involved in PIM meetings with regulatory bodies.
• Setup process for our clients to meet clinical data sharing and anonymization requirements.
• Presentation at conferences on our experiences with anonymization of clinical data, risk assessment, PRCI and CBI information.
o Commercially Confidential Information in clinical data publishing
o Do’s and Don’ts for PRCI submissions
o Beyond k-anonymity for Clinical Trial Data anonymization
o Evaluation of Re-identification Risk for Anonymized Clinical Documents