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Amba Hotel Marble Arch

Dec 06, 2016 8:00 AM - Dec 07, 2016 5:30 PM

Bryanston Street , London, W1H 7EH, United Kingdom

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.

SESSION 6: EU PORTAL & DATABASE

Session Chair(s)

Anne  De Bock

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)

Noemie  Manent, PharmD

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

Noemie Manent, PharmD

TDA-CTT Change Management Lead, European Medicines Agency, Netherlands

John  Poland, PhD

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

John Poland, PhD

Regulatory Affairs Consultant, Association of Clinical Research Organizations (ACRO), United Kingdom

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