EMA getting ready for the publication of clinical data

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08/06/2015

EMA getting ready for the publication of clinical data

Webinar on 24 June to provide update on implementation of policy

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 information, please see the agenda of the webinar.

A live broadcast of the webinar will be available on EMA's website. However, spaces to participate in the webinar are limited. All individuals who wish to participate should register their interest by sending an email with their contact details to clinicaldatapolicywebinar@ema.europa.eu by 19 June 2015.

A face-to-face meeting will be organised on 6 July 2015 at the EMA to allow more detailed discussions on the guidance on anonymisation and redaction of personal data and on what is not considered commercially confidential information. More details on this meeting will follow shortly.

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