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Millennium Hotel London Mayfair

Dec 06, 2017 12:30 PM - Dec 07, 2017 4:45 PM

44 Grosvenor Square Mayfair, London, W1K 2HP, United Kingdom

The Evolution of Policy 0070: EMA Clinical Data Publication

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Session 3: Lessons Learned

Session Chair(s)

Julie Holtzople

Julie Holtzople

Independent Consultant, Holtzople Consulting, United States

The industry has seen the publication of over 50 clinical redacted document packages by the EMA since the start of the EMA Policy 0070 process. In this session we will look at the delivery process end to end and discuss with members of the pharmaceutical industry and the EMA lessons learned and best practices that have emerged in successful submission and publication.

Speaker(s)

Anne-Sophie Henry-Eude, PHARMD

Anne-Sophie Henry-Eude, PHARMD

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

Despina Poulimenou, MBA

Despina Poulimenou, MBA

Clinical Data Publication Manager, European Medicines Agency, Netherlands

Stephen John Kroll, MS

Stephen John Kroll, MS

Director, Medical Communications, Bristol-Myers Squibb Company, United States

Ada Adriano, MSC

Ada Adriano, MSC

Clinical Data Publication Manager, European Medicines Agency, Netherlands

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