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EMA Proactive Transparency – Clinical Data Publication (Policy 0070)

Track:
What Can Stakeholders Expect from Clinical Trial (Development), Transparency and Medical Information?

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0601

Room Number:
Boston 1-2

Type:
Session

Title:
EMA Proactive Transparency – Clinical Data Publication (Policy 0070)

Chair(s):
Melanie Carr
Head of Stakeholders and Communication
European Medicines Agency (EMA), European Union, United Kingdom

Description:
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.

Presentation(s) & Speaker(s):
Experience and Lessons Learned to Date
Joao Ferreira, PharmD
Clinical Data Publication Manager
European Medicines Agency (EMA) , United Kingdom

SME and Big Pharma Perspectives on the Publication Process
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

How Use Can Be Made of the Data – An Academic’s Viewpoint
Sarah Nevitt
Department of Biostatistics
University of Liverpool, United Kingdom

Why Increased Transparency is Important for Patients
David Haerry
European AIDS Treatment Group, Belgium