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Mercure Hotel Amsterdam City

Dec 04, 2019 8:00 AM - Dec 05, 2019 5:00 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 2: Global Harmonization for Clinical Trial Transparency and Disclosure

Session Chair(s)

Karla  Childers, MS

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

Panelist:

Director, Human Subject Research Governance, GSK, United Kingdom

Anne-Sophie  Henry-Eude, PHARMD

Panelist:

Head of Documents Access and Publication Department, European Medicines Agency, Netherlands

Nate  Root, MSC

Panelist:

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals, United States

Andre  Molgat, PHD

Panelist:

Head of Operations, Public Release of Clinical Information, Health Canada, Canada

Merete  Joergensen, MBA, MSC

Panelist:

Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark

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