On request of either committee, the QWP is involved in:

  • the preparation, review and update of quality guidelines;
  • the provision of scientific advice on general and product-specific matters relating to quality;
  • the resolution of national divergences regarding the assessment of quality issues;
  • liaison with interested parties;
  • international co-operation on quality-related matters, including with the European Directorate for the Quality of Medicines and Healthcare (EDQM).

All recommendations drawn up by the QWP are transmitted to the relevant committee for adoption.

Mandate, rules of procedure and work programme

The updated mandate and rules of procedure will be published once available.

Information on this working party's responsibilities, composition, procedures and activities is available in the following documents:

3-year work plan for the joint CHMP/CVMP Quality Working Party 2024-2026

Mandate, objectives and rules of procedure for the joint CHMP/CVMP Quality Working Party

Composition

The QWP is composed of European experts selected according to their specific expertise in the area of quality assessment.

CVMP and CHMP members are invited to nominate one expert per Member State for products for human use and, where there is a separate agency for veterinary medicinal products, one expert per Member State for products for veterinary use.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) may also nominate an observer to participate in the work of the QWP.

Members

Below (in alphabetical order of surname) are the current members of the QWP. The members' declarations of interests are available in the European expert list.

  • Tone Agasoster
  • Fernando Blanco
  • Peter Caspers
  • Eugenia Cogliandro
  • Andrea Cseh-Pálos
  • Bart Denayer
  • Dorota Distlerova
  • Lucija Fasalek
  • Gernot Hirn
  • Blanca Hirschlerova (chair)
  • Christopher Janich
  • Karin Krogars
  • Nicholas Lee (vice-chair)
  • Jobst Limberg
  • Olaf Ludek
  • Ivica Malnar
  • Maryam Mehmandoust
  • Mary O’Grady
  • Kristofer Olofsson
  • Silvia Perez Lopez
  • Piet-Hein Overhaus
  • Carmen Purdel
  • Annika Ridell
  • Marie-Helene Sabinotto (vice-chair)
  • Laivi Saaremael
  • Christian Spiteri
  • Josef Suchy
  • Ivana Tasevska
  • Patricia Vera Luque
  • Tina Visholm Jensen
  • Tiago Vistulu De Abreu
  • Anna Zadrozna

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