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Session 2: Global Harmonization for Clinical Trial Transparency and Disclosure
Session Chair(s)
Karla Childers, MS
Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States
In this session we will look at emerging goals and opportunities sponsors view as possibilities for global harmonization in Clinical Trial Transparency. We will discuss the ideology along with the risks, benefits and opportunities for harmonization in Clinical Trial Transparency globally. Objectives: • Highlight incremental steps that can lead towards successful global harmonization • Look at additional opportunities for increased harmonization • Discuss global CTT harmonization opportunities as they relate to all stakeholders
Speaker(s)
Panelist:
Anne Cutting
GSK, United Kingdom
Director, Human Subject Research Governance
Panelist:
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
Panelist:
Nate Root, MSc
Ionis Pharmaceuticals, United States
Associate Director, Disclosure and Transparency
Panelist:
Andre Molgat, PhD
Health Canada, Canada
Head of Operations, Public Release of Clinical Information
Panelist:
Merete Joergensen, MBA, MSc
Merete-J Consulting CVR: 34920818, Denmark
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
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