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Policy 0070 • Data Anonymization • Lay Summaries • Patient-Level Data Disclosure • International Registries

January 30-31, 2018
  • Philadelphia, PA

Join CBI’s 5th Annual Clinical Data Disclosure and Transparency conference to navigate regulatory changes at both the U.S. and international level, develop strategies to anonymize and release patient level data, ensure compliance with disclosure and transparency requirements and achieve meaningful patient engagement through comprehensive lay summaries. Gain insight from an expert speaking faculty, discussing and disseminating the latest information related to Title VIII of FDAAA Final Rule and complimentary NIH policy, EMA Policy 0070, ICMJE requirements, data anonymization, sharing patient-level data and international registries.

Progressive Insights and Industry Perspectives from Disclosure and Transparency Experts:

  • Moving Beyond Phase I of Policy 0070 —
    Quantified Risk Assessments, Anonymization and EMA Timelines
  • Implications of Transparency on Publication Requirements
  • Explore NIH Clinical Trials Reforms and Navigate New Requirements
  • Navigate New EU Clinical Trials Regulation and Prepare for
    Anticipated 2018 EU Portal and Database
  • Protect Patient Privacy and Preserve Regulatory Integrity when
    Sharing Patient-Level Data
  • Improve Communication and Ignite Collaboration to Achieve
    Meaningful Patient Involvement
  • Anonymize Data Sharing Standards at the Local and Global Level
  • Achieve Patient Engagement Through Lay Summary Documents
    in Clinical Trials

Previous Attendee Acclaim:

Fantastic conference with very knowledgeable speakers on content. I strongly recommend this conference to new folks, as well as those already in the Pharma environment to attend so that they can have a better understanding of transparency.

Clinical Trial Transparency Coordinator, AstraZeneca

A great forum for updates and trends on the evolving trial transparency landscape and compliance.

Director, Clinical Trial Disclsoure, Sanofi