Current status of European Medicines Agency policy on publication of clinical data - Stakeholder webinar

• Date:
  Miercuri, 24 iunie 2015, Toată ziua
• Locație:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) is organising a webinar on the implementation of its policy on publication of clinical data for medicinal products for human use, which came into effect on 1 January 2015. The aim of the webinar is to update stakeholders on the progress the Agency has made on the implemetation of the policy. The topics covered by the webinar will include an explanation of the principles for the submission of redacted clinical reports, the redaction consultation process, as well as guidance on what is and is not considered commercially confidential information and on the anonymisation and redaction of personal data in clinical reports. Registration closed.

Documents

Agenda – Implementation of EMA policy on publication of clinical data – Current status – Stakeholder webinar

Reference Number: EMA/380643/2015

Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use

Reference Number: EMA/357536/2014 Rev.2

Presentation - Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports (Anne-Sophie Henry-Eude)

Presentation - EMA policy on publication of clinical data – Update on implementation (Noel Wathion)

Presentation - Guidance on the anonymisation of clinical reports for the purpose of publication in accordance with policy 0070 (Monica Dias)

Presentation - Redaction consultation process (Anne-Sophie Henry-Eude)

Presentation - Guidance on the sSubmission of clinical reports intended for publication in accordance with Policy 0070 (Frances Nuttall)

Multimedia