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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

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)

Anne  Cutting

Panelist:

Anne Cutting

GSK, United Kingdom

Director, Human Subject Research Governance

Anne-Sophie  Henry-Eude, PharmD

Panelist:

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Nate  Root, MSc

Panelist:

Nate Root, MSc

Ionis Pharmaceuticals, United States

Associate Director, Disclosure and Transparency

Andre  Molgat, PhD

Panelist:

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

Merete  Joergensen, MBA, MSc

Panelist:

Merete Joergensen, MBA, MSc

Merete-J Consulting, Denmark

Clinical Disclosure and Transparency Expert

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