The European Medicines Agency (EMA) will hold a webinar on Wednesday 24 June to update stakeholders on the implementation of its policy on publication of clinical data.

This landmark policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports will be published as soon as a decision on the application has been taken, currently foreseen for mid-2016.

In preparation for this major initiative, EMA is currently building a new system for the publication of reports and is defining a series of work processes with its stakeholders. To ensure a successful implementation of the policy, EMA will clarify various aspects that need to be anticipated by stakeholders.

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.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/06/news_detail_002343.jsp&mid=WC0b01ac058004d5c1