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Mercure Hotel Amsterdam City

2019年12月04日 (水) 午前 8:00 - 2019年12月05日 (木) 午後 5:00

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

Anne Cutting

Director, Human Subject Research Governance, GSK, United Kingdom

Panelist:

Anne-Sophie  Henry-Eude, PHARMD

Anne-Sophie Henry-Eude, PHARMD

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

Panelist:

Nate  Root, MSC

Nate Root, MSC

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

Panelist:

Andre  Molgat, PHD

Andre Molgat, PHD

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

Panelist:

Merete  Joergensen, MBA, MSC

Merete Joergensen, MBA, MSC

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

Panelist:

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