Working Group on Quality Review of Documents

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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.

Meeting dates

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

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.

  • Maria Eleni Avraamidou
  • Maria Azevedo Mendes
  • Mariette Backes-Lies
  • Jelena Biruš
  • Anca Bitoiu
  • Loreta Bobrovičiūtė
  • Marina Brancheva
  • Liene Burkāne
  • Stephanie Busse
  • Sara Camilleri
  • Emma Cassar-Buontempo
  • Maija Cirkina
  • Maria Grazia Evandri
  • Godwin Farrugia
  • Blanca Garcia-Ochoa
  • Jacqueline Genoux-Hames
  • Heike Gyra
  • Miklos Harmos
  • Kamila Hrochova
  • Fredrik Hussenius
  • Bernard Jendrašinkin
  • Sharon Jones
  • Marjeta Jordan
  • Paula Kajaste
  • Ene Kenkmann
  • Annette Kristensen
  • Karin Krogars
  • Rozalina Kulaksazova
  • Marcela Kulcsárová
  • Ingrid Leentjens
  • Laëtitia Le Letty
  • Johann M. Lenhardsson
  • Ana Loureiro
  • Jan MacDonald
  • Ioannis Malemis
  • Nina Malvik
  • Denisse Mazilu
  • Edward Mc Gettrick
  • Dries Minne
  • Florence Montanier
  • Annamária Mosolygó-Telepó
  • Françoise Mosselmans
  • Leona Nepejchalová
  • Vaidilute Nomeikienė
  • Dimitrina Novakova
  • Eugen Obermayr
  • Rita Offermann
  • Rafael Ortega Huedo
  • Ioanna Pelekani Talioti
  • Anita Piwowarczyk
  • Marcela Poláková
  • Alexandrina Preda
  • Christiane Rahn
  • Daniela Raneri
  • Delphine Rousseau
  • G Johan Schefferlie
  • Petra Šegina
  • Evelina Shumkova
  • Dagbjort Sigvaldadottir
  • Marianne Solsvik
  • Stephen Spiteri
  • Katarina Štraus
  • Simona Sturzu
  • Adriana Tomaskovicova
  • Eva Vernerova
  • Afrodite Voulgari
  • Katarina Vučić
  • Anna Wachnik-Święcicka
  • Marta Wagnerova
  • Dominique Westphal
  • Petra Wiesinger