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Navigating EMA Policy 0070—How Do We Ensure Compliance?

On-Demand Webinar

EMA Policy 0070 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. Anonymizing sensitive information from clinical trial documents while maintaining their clinical utility is a daunting task.

Attend this webinar with Lora Killian, Director of Transparency and Disclosure at Synchrogenix, a Certara company, to learn how EMA Policy 0070 will affect your organization and how to facilitate compliance. She will address the following critical transparency and disclosure issues:

  • The old requirements vs. new detailed requirements for clinical reports
  • New timelines and milestones for redacting and publishing clinical reports
  • Short-term compliance deliverables: patient narratives, CCI justification tables and validation, and anonymization reports
  • Which anonymization techniques best preserve data utility and result interpretation while preventing subject re-identification

About Our Speaker

Webinar-1speaker-KillianLora Killian, Director of Transparency and Disclosure, has over 12 years of pharmaceutical and business operations experience. She is responsible for the development and oversight of Synchrogenix’s entire suite of transparency services which includes anonymization, clinical trial disclosure, and lay language summary development. Ms. Killian has played an integral role consulting with sponsors in the development of company-specific transparency policies to address the latest wave of regulation arising out of the EU and the US.

EMA Policy 0070 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. Anonymizing sensitive information from clinical trial documents while maintaining their clinical utility is a daunting task.

Watch this webinar with Lora Killian, Director of Transparency and Disclosure at Synchrogenix, a Certara company, to learn how EMA Policy 0070 will affect your organization and how to facilitate compliance. She addressed the following critical transparency and disclosure issues:

  • The old requirements vs. new detailed requirements for clinical reports
  • New timelines and milestones for redacting and publishing clinical reports
  • Short-term compliance deliverables: patient narratives, CCI justification tables and validation, and anonymization reports
  • Which anonymization techniques best preserve data utility and result interpretation while preventing subject re-identification
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