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EMA Proactive Transparency – Clinical Data Publication (Policy 0070)
Session Chair(s)
Melanie Carr
Head of Stakeholders and Communication Division
European Medicines Agency, Netherlands
With more than one year of experience of publishing clinical data in the EU, this session will feature different stakeholders perspectives on the impact that this increased level of transparency is having. Panellists will share some of the lessons learned and best practices that have emerged with successful submissions and publication as well as areas where there is still further room for improvement.
Speaker(s)
Experience and Lessons Learned to Date
Joao Ferreira, PHARMD
European Medicines Agency, Netherlands
Clinical Data Publication Manager
SME and Big Pharma Perspectives on the Publication Process
Stephen Bamford
Janssen Research & Development, United Kingdom
Director, Head of Data Transparency
SME and Big Pharma Perspectives on the Publication Process
Silvia Nosari, DRSC
Adienne Pharma & Biotech, Italy
Chief Regulatory Affairs Officer
Sarah Nevitt
University of Liverpool, United Kingdom
Department of Biostatistics
Why Increased Transparency is Important for Patients
David Haerry
EATG, Switzerland
Patient Advocate