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Millennium Hotel London Mayfair

2017 年 12 月 06 日 12:30 下午 - 2017 年 12 月 07 日 4:45 下午

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

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Despina Poulimenou, MBA

Despina Poulimenou, MBA

European Medicines Agency, Netherlands

Clinical Data Publication Manager

Stephen John Kroll, MS

Stephen John Kroll, MS

Bristol-Myers Squibb Company, United States

Director, Medical Communications

Ada Adriano, MSC

Ada Adriano, MSC

European Medicines Agency, Netherlands

Clinical Data Publication Manager

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