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Millennium Gloucester Hotel London Kensington

Sep 24, 2014 8:00 AM - Sep 25, 2014 5:30 PM

4-18 Harrington Gardens, London, SW7 4LH, United Kingdom

Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice

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THU Session 3: OPERATIONAL ASPECTS OF DATA SHARING: EudraCT

Session Chair(s)

Merete Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials

Merete-J Consulting CVR: 34920818, Denmark

How to cope with the posting back to 2004?

Speaker(s)

Azin Shahzamani

How to cope with the posting back to 2004?

Azin Shahzamani

Genentech, A Member of the Roche Group, United States

Senior Director, Regulatory Affairs

Noemie Manent, PharmD

EMA – Practical considerations of EudraCT and EU CTR postings, and international context

Noemie Manent, PharmD

European Medicines Agency, Netherlands

TDA-CTT Operations Workstream Lead

Rebecca Williams, PharmD, MPH

US Requirements on Results Reporting – and international context

Rebecca Williams, PharmD, MPH

Essex, Part of Emmes Group, United States

Senior Clinical Trials Subject Matter Expert

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