Quality Working Party
The Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) on matters relating directly or indirectly to the quality of human or veterinary medicinal products.
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
More information on the QWP's responsibilities, composition, procedures and activities is available in the following documents:
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Mandate, objectives and rules of procedure for the joint CHMP/CVMP Quality Working Party (PDF/116.26 KB)
First published: 10/07/2007
Last updated: 06/03/2019
EMA/CHMP/CVMP/QWP/65702/2016 Rev. 1 -
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Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2023 (PDF/312.25 KB)
First published: 31/01/2023
EMA/CHMP/CVMP/QWP/822156/2022
EMA has temporarily suspended or scaled back certain activities since 2019 based on EMA’s business continuity plan and during the COVID-19 pandemic. QWP is set for reorganisation in 2023, as part of EMA's revised operating model for working parties. Until then, QWP continues to work under its current mandate. The updated mandate and rules of procedure will be published once available. |
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.
Members
- Tone Agasøster
- Luisa Arreaza Lopez
- Miriam Bartolo
- Jens-Uwe Bleich
- Silvia Cârstoiu
- Peter Caspers
- Eugenia Cogliandro
- Andrea Cseh-Pálos
- Viola Csomor
- Domingos de Carvalho Ferreira
- Ruth Demarco
- Bart Denayer
- Ines Dias
- Diyana Dimitrova
- Dorota Distlerova
- Zuzana Dzupinova
- Kyriaki Fakinou
- Lucija Fasalek
- Zuzana Fliegerová
- Blanka Hirschlerova (Chair)
- Christina Højelse
- Tina Visholm Jensen
- Karin Krogars
- Demetra Kyriakidou
- Nicholas Lee
- Jobst Limberg
- Olaf Ludek
- Ivica Malnar
- Maryam Mehmandoust
- Norbert Moller
- Mary O'Grady
- Kristofer Olofsson
- Piet-Hein Overhaus
- Dace Peiseniece
- Vladislav Petkov
- Daniela Plosceanu
- Monika Posega
- Viktorija Pruse
- Carmen Purdel
- Alessandro Maria Renier
- Annika Ridell
- Gianluca Antonio Romeo
- Laivi Saaremäel (Vice-Chair)
- Marie-Hélène Sabinotto (Vice-Chair)
- Ksenija Šandor
- Bojana Stavar Mocnik
- Susanne Stotter
- Josef Suchy
- Indre Sveikauskaite-Radučienė
- Maja Tabak-Slošić
- Ivana Tasevska
- Katrien Van Landuyt
- Maria Vassiliou
- Patricia Vera Luque
- Vassilis Violakis
- Tiago Vistulo De Abreu
- Natalia Wąsowicz-Żendzian
- Anna Zadrozna