Working Group on Quality Review of Documents

The Working Group on Quality Review of Documents (QRD) provides assistance to the European Medicines Agency's scientific committees and to companies on linguistic aspects of the product information for medicines. This includes summaries of product characteristics, labelling and package leaflets.

The QRD's tasks include:

  • ensuring linguistic clarity, consistency and accuracy of the product information;
  • verifying the terminology used in translations and their consistency with the original versions;
  • promoting legibility of product information;
  • reviewing and updating templates for opinions of the scientific committees and for product information, to ensure compliance with European Union (EU) rules on medicinal products and taking practical experience into account;
  • contributing to the development of a common understanding on the implementation of legislation and guidelines in relation to product information and labelling.

Mandate of the QRD Working Group

Meeting dates

The QRD's meeting dates are available in this document:


The QRD is composed of two experts per Member State, one for human and one for veterinary medicinal products, selected by the national competent authorities. They all have appropriate expertise in regulatory and linguistic areas, as well as in product information and labelling for medicines

In addition, one representative each from the European Commission, the Translation Centre for the Bodies of the European Union (CdT) and the Agency secretariat participate in the work of the QRD.

The Agency chairs the group and provides secretarial support.


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


  • Sergejs Akulics
  • Javier Alonso Naveda
  • Ana Andre
  • Lilia Asenova
  • Zanda Auce
  • Ieva Ausrotaite
  • Maria Bartolo
  • Diana Laura Bassula
  • Marcela Beková
  • Stephanie Busse
  • Sara Camilleri
  • Emma Cassar Buontempo
  • Katarzyna Chrobak
  • Gabriella Csontos
  • Daniel Delwiche
  • Ines Dias
  • Niclas Falk
  • Susanna Georgi
  • Iva Gruden Zdunic
  • Paula Kajaste
  • Ene Kenkmann
  • Vanja Kilibarda
  • Theoni Kousteni
  • Svjetlana Krnic
  • Rozalina Kulaksazova
  • Gábor Kulcsár
  • Nathalie Lagrange
  • Karine Le Dortz
  • Caroline LEROUX
  • Nina Malvik
  • Daniela Mares
  • Kirsten Martin
  • Alma Moffett
  • Daniela Motiu
  • Leona Nepejchalová
  • Nicolas Nyssen
  • Rafael Olecki
  • Conor OReilly
  • Amalia Papadaki
  • Anita Piwowarczyk
  • Alexandrina Preda
  • Mojca Pust
  • Kristina Raczova
  • Matija Radovanovic
  • Daniela Raneri
  • Danila Renzo
  • Intse Romein
  • Delphine Rousseau
  • Nina Ruso
  • Sandra Schack
  • Kim Sherwood
  • Evelina Shumkova
  • Dagbjort Sigvaldadottir
  • Stephen Spiteri
  • Nijole Stankeviciene
  • Triin Teppor
  • Justine Timonnier
  • Marta Giovanna Toma
  • Mette Tranholm
  • Monique van Raamsdonk
  • Eva Vernerova
  • Marta Wagnerova
  • Petra Wiesinger
  • Stephanie Zeitouni