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Session 2: Global Harmonization for Clinical Trial Transparency and Disclosure
Session Chair(s)
Karla Childers, MS
Vice President, Bioethics, Policy & Partnerships, 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)
Anne Cutting
Director, Human Subject Research Governance, GSK, United Kingdom
Panelist:
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
Panelist:
Nate Root, MSC
Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals, United States
Panelist:
Andre Molgat, PHD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Panelist:
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
Panelist: