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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)
Joao Ferreira, PHARMD
Clinical Data Publication Manager, European Medicines Agency, Netherlands
Experience and Lessons Learned to Date
Stephen Bamford
Director, Head of Data Transparency, Janssen Research & Development, United Kingdom
SME and Big Pharma Perspectives on the Publication Process
Silvia Nosari, DRSC
Chief Regulatory Affairs Officer, Adienne Pharma & Biotech, Italy
SME and Big Pharma Perspectives on the Publication Process
Sarah Nevitt
Department of Biostatistics, University of Liverpool, United Kingdom
David Haerry
Patient Advocate, EATG, Switzerland
Why Increased Transparency is Important for Patients
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