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

Mandate and objectives for the European Medicines Agency Working Party on Quality Review of Documents (QRD)

Reference Number: EMA/403106/2014

Meeting dates

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

Quality Review of Documents (QRD) working group plenary meeting dates

Composition

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.

Members

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.

• Malin Ålander
• Javier Alonso Naveda
• Ana Andre
• Zanda Auce
• Ieva Ausrotaite
• Maria Bartolo
• Diana Laura Bassula
• Marcela Beková
• Emelie Bergman Perland
• Susanne Breedijk-van den Ende
• Anne Hasle Buur
• Helga Cassar
• ANNA CHALAMPALA
• Katarzyna Chrobak
• Ines Dias
• Voinka Dimitrova
• Iva Gruden Zdunic
• Ene Kenkmann
• Vanja Kilibarda
• Svjetlana Krnic
• Rozalina Kulaksazova
• Gábor Kulcsár
• Karine Le Dortz
• Caroline LEROUX
• Nina Malvik
• Kirsten Martin
• Daniela Motiu
• Michelle Mulchrone
• Leona Nepejchalová
• Nicolas Nyssen
• Rafael Olecki
• Conor OReilly
• Amalia Papadaki
• Dace Peiseniece
• Anita Piwowarczyk
• Alexandrina Preda
• Mojca Pust
• Matija Radovanovic
• Daniela Raneri
• Vaida Ribokaitė
• Elena Rodrigo Serrano
• Intse Romein
• Angeliki Rompoti
• Delphine Rousseau
• Nina Ruso
• Sandra Schack
• Kim Sherwood
• Evelina Shumkova
• Dagbjort Sigvaldadottir
• Judita Skladaná
• Marianne Solsvik
• Stephen Spiteri
• Triin Teppor
• Juliane Teubel
• Marta Giovanna Toma
• Tamás Tóth
• Veera Vaharautio
• Eva Vernerova
• Marta Wagnerová
• Dominique Westphal
• Petra Wiesinger
• Serena Zamponi
• Stephanie Zeitouni