EMA Updates Implementation for New Clinical Data Policy

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-09-2015 09:30


The European Medicines Agency (EMA) will hold a webinar on Wednesday June 24, 2015, to update stakeholders on the implementation of its policy on publication of clinical data.

The EMA's new policy, which became effective January 1, 2015, applies to clinical reports contained in all marketing-authorization 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, the 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, the 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 anonymization and redaction of personal data in clinical reports.

A live broadcast of the webinar will be available on EMA's website. However, spaces to participate interactively in the webinar are limited. All individuals who wish to participate should register by June 19, 2015.

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

Source: EMA


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