quality management

The quality management system of the Medicines Evaluation Board (MEB) is again this year certified on the basis of the ISO 9001-2008 standard.

The MEB was the first European authorisation agency to have its quality management certified.

Case Control Study 2014

This audit has found that the following subjects have been effectively elaborated:

  • Policy objectives are consistently monitored in a structured way (B1, ISO 5.4.1). From the overall strategic objectives, concrete department objectives have been formulated, the progress of  those objectives are  accurately monitored by the quality team based on a well-structured Excel overview. This results at the start of the new policy cycle in a clear overview of which (sub-)objectives have been realised in the past year and which objectives must or must not be included once more in the policy for the next year.
  • The smart working smart building principles, the term used within MEB for ‘@nders werken’, is implemented in a controlled way (O1, ISO 8.5.3). The interviews show that the smart working smart building principles  is demonstrably starting to  pay off. The MEB has also established in a recent survey that the employees are satisfied with this approach. Paperless working based on ICI contributes to the efficiency and quality of the primary processes and the ICT instruments support working at home increasingly better. Due to the centralised accommodation, there is extensive interaction between employees of the different departments.
  • The quality of the  assessment processes is effectively guaranteed (P2, ISO 7.5.1). In the primary process, various checks are carried out that ensure that the quality of the  assessments is optimally guaranteed. Examples of quality checks include the peer reviews, the check on formal requirements by the RPL, and the various (national and international) bodies that monitor quality.

Pharmacovigilance audits

According to article 101 (2) of the Directive 2001/83/EC  it is mandatory for Member States  to perform regular audits of their Pharmacovigilance system and to report the results to the European Commission. The report has been published:

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