Standards for validating health measures definition and content

If a company has made arrangements with a third-party service provider to submit data on medicines on their behalf, it is sufficient that a staff member of the third-party service provider has successfully completed the training.

XEVMPD training is also available to users from national competent authorities.

The course is available as a series of presentations, videos and step-by-step guides. As the training videos do not reflect changes to the Article 57 format and XSD (extensible markup language schema definition) schema applicable as of 16 June 2014, step-by-step guides were created to provide up-to-date information: After finishing the e-learning course, users can perform an XEVMPD knowledge evaluation.

At least one user from each marketing authorisation holder or sponsor of clinical trials should receive training.

Users who have successfully completed the training offered by the Agency and the Eudra Vigilance registration process can start to submit data to the Agency.

The NSQHS Standards (second edition) have been submitted to health ministers for approval.

The launch of the NSQHS Standards (second edition) is planned for November 2017, with assessment to commence from January 2019.

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