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EMA’s Policy on Clinical Publication: Opportunities, Challenges and Measuring Success
Session Chair(s)
Susan Forda, PhD
VP, GLobal Regulatory Affairs International
Eli Lilly & Company Ltd., United Kingdom
Marie-Agnes Heine, MA
Head of Communication Department
European Medicines Agency, Netherlands
The implementation of EMA’s policy on the publication of clinical data (policy 70) will open up huge opportunities for the wide use of these data by stakeholders, which is expected to result in benefits for public health. EMA is the first regulatory authority worldwide to provide such broad access to clinical data. As of October 2016, for every new medicine, citizens, including researchers and academics, are able to directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing-authorisation applications. This session will elaborate on the opportunities and challenges that the new policy brings.
Speaker(s)
EMA’s Policy 70: Status of Implementation
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
Opportunities and Challenges the Policy Brings
Susan Forda, PhD
Eli Lilly & Company Ltd., United Kingdom
VP, GLobal Regulatory Affairs International
How Can Academics Use the Data and Can Clinical Study Reports Be Leveraged as Big Data?
Tom Jefferson
Centre for Evidence-Based Medicine, United Kingdom
Honorary Research Fellow
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