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.

Mandate of the QRD Working Group

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.

  • Rica Albuschat
  • Javier Alonso Naveda
  • Ana Andre
  • Zanda Auce
  • Maria Eleni Avraamidou
  • Maria Azevedo Mendes
  • Margareta Bego
  • Marcela Beková
  • Loreta Bobrovičiūtė
  • Marina Brancheva
  • Stephanie Busse
  • Sara Camilleri
  • Emma Cassar Buontempo
  • Maija Cirkina
  • Petra Docolomanska
  • Maria Grazia Evandri
  • Godwin Farrugia
  • Blanca Garcia-Ochoa
  • Jacqueline Genoux-Hames
  • Maja Golobic
  • Heike Gyra
  • Miklos Harmos
  • Bernard Jendrašinkin
  • Marjeta Jordan
  • Paula Kajaste
  • Tarja Kankkunen
  • Ene Kenkmann
  • Theoni Kousteni
  • Sonja Krivokapic
  • Rozalina Kulaksazova
  • Nathalie Lagrange
  • Ingrid Leentjens
  • Laëtitia Le Letty
  • Johann M. Lenhardsson
  • Jan MacDonald
  • Ioannis Malemis
  • Nina Malvik
  • Deirdre Mannion
  • Denisse Mazilu
  • Gloria McAndrew
  • Florence Montanier
  • Annamária Mosolygó-Telepó
  • Françoise Mosselmans
  • Pauline Murray
  • Leona Nepejchalová
  • Dimitrina Novakova
  • Rita Offermann
  • Anita Piwowarczyk
  • Alexandrina Preda
  • Daniela Raneri
  • Vaida Ribokaitė
  • Delphine Rousseau
  • Gerrit Johan Schefferlie
  • Renee Sheehan
  • Kim Sherwood
  • Evelina Shumkova
  • Dagbjort Sigvaldadottir
  • Despoina Skivalou
  • Stephen Spiteri
  • Simona Sturzu
  • Triin Teppor
  • Valérie Van Merris
  • Eva Vernerova
  • Anna Wachnik-Święcicka
  • Marta Wagnerova
  • Dominique Westphal
  • Petra Wiesinger