Second stakeholder meeting on the implementation of the European Medicines Agency's policy on publication of clinical data for human medicines

• Date:
  Monday, 7 September 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

On 7 September 2015 the European Medicines Agency (EMA) organised a face-to-face meeting to follow-up the meeting which took place on 6 July. The aim of this meeting was to further consult with stakeholders on the two sets of guidance under development, on the identification and redaction of commercially confidential information in the clinical reports submitted to the EMA for publication, and on the anonymisation of the clinical reports, in the context of the policy. EMA also presented new technical guidance on the procedural aspects related to the submission of the clinical reports, for example practical matters of how material should be sent to EMA, as well as the workflow of the redaction consultation process and the overall process leading to publication.

Documents

Draft agenda - Second stakeholder meeting on the implementation of EMA policy 0070 (on the publication of clinical data)

DraftReference Number: EMA/552187/2015

Summary – Second stakeholder meeting on the implementation of EMA policy 0070 (on publication of clinical data for medicinal products for human use)

Reference Number: EMA/600317/2015

Presentation - External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070): Second stakeholder meeting on the im...

Presentation - Key aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA Policy 0070: Second stakeholder meeting on the implementation of EMA policy 0070 (on the pub...