Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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SESSION 6: EU PORTAL & DATABASE

Session Chair(s)

Anne De Bock

Sr Regional Director

AstraZeneca, Belgium

What is the status quo and what can you expect to happen in 2017? This session will answer these questions in form of high-level presentations followed by a panel discussion that focuses on the learnings so far from user-acceptance testing.

Speaker(s)

The EU Portal and Database: What to Expect. Demo of the draft Portal.

Noemie Manent, PharmD

European Medicines Agency, Netherlands

TDA-CTT Operations Workstream Lead

A stakeholder's perspective of the EU clinical trials portal and database

John Poland, PhD

Association of Clinical Research Organizations (ACRO), United Kingdom

Regulatory Affairs Consultant

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