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EMA Policy 0070 Relaunch - Changes and how GenInvo can help

The pre-launch EMA webinar emphasized the importance of early preparation and quality checks before submitting packages, along with proper justification of CCI redactions. GENINVO offers support for anonymization, providing an experienced team and an automation tool called SHADOW. Their solution complies with regulations, reduces anonymization time, and has a successful track record with EMA 0070 and Health Canada PRCI submissions. GENINVO's expertise extends to PIM meetings, helping clients meet clinical data sharing requirements, and presenting at conferences.

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EMA Policy 0070 Relaunch - Changes and how GenInvo can help

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  1. 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 Contact us Email: info@geninvo.com Website: www.geninvo.com

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