Granularity and Periodicity Advisory Group

The Granularity and Periodicity Advisory Group (GPAG) provides advice to the Pharmacovigilance Risk Assessment Committee (PRAC) relating to amendments of the European Union Reference Dates (EURD) list.

For more information, see:

• Working parties and ther groups

Responsibilities

The working group's tasks include:

• Advising PRAC on the monthly review and update of the European Union Reference Dates (EURD) list
• Defining the scientific scope of each single assessment procedure in the EURD list and ensuring that terminology is clear and consistent
• Developing guidance and criteria to determine the frequency of single assessment procedures, based on scientific judgment

The working group's work takes into account existing knowledge about the benefit-risk profile of active substances or their combinations, as well as the regulatory tools to further monitor and review those profiles.

It determines the frequency of periodic safety update reports (PSURs) and their data lock points using a risk-based approach, in line with the criteria set out in Good Pharmacovigilance Practices (GVP), Annex IV.

For more information, see:

• Good pharmacovigilance practices (GVP)

Composition

In addition to PRAC members, the working group is composed of:

• PharmacoVigilance Work Sharing Procedures Working Party members;
• National competent authorities experts;
• EMA experts.

The best available expertise needed to deliver the group’s commitments is considered when selecting experts to this group.