Biologics Working Party

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The Biologics Working Party (BWP) provides recommendations to the European Medicines Agency's scientific committees on all matters relating directly or indirectly to quality and safety aspects relating to biological and biotechnological medicines.

The BWP's tasks include:

  • providing support to the Committee for Medicinal Products for Human Use (CHMP) on dossier evaluation, to facilitate consistency of assessments and the coherence of CHMP opinions;
  • at the request of the CHMP, providing scientific advice on general and product-specific matters relating to the quality aspects of biological and biotechnological medicinal products;
  • preparing, reviewing and updating guidelines, in conjunction with other appropriate working parties;
  • liaising with interested parties, such as pharmaceutical industry associations, learned societies, healthcare-professional organisations and patient organisations;
  • international cooperation on the quality and safety of biological and biotechnological medicinal products;
  • contributing to CHMP scientific opinions in collaboration with the World Health Organization (WHO) for the evaluation of medicines intended for markets outside the European Union (EU);
  • acting as a focus and catalyst for training;
  • contributing to and organising workshops and training sessions on the quality and safety of biological and biotechnological medicinal products;
  • interacting with the European Directorate for the Quality of Medicines and Healthcare (EDQM), particularly in relation to European Pharmacopoeia activities, biological standardisation and the activities of the Official Medicines Control Laboratory (OMCL) network;
  • preparing statements on general or product-specific matters for the public;
  • on request of the CHMP, constituting a rapid-acting crisis group to take on specific issues relating to the quality of biological or biotechnological medicinal products, including quality in relationship to safety aspects, with the objective of exchanging information on a European level and co-ordinating responses to the public in a timely manner.

Mandate, rules of procedure and work programme

More information on the BWP's responsibilities and composition are available in these documents:

Composition

The BWP is composed of European experts selected according to their specific expertise.

All members of the CHMP are invited to nominate one expert to be a member of the BWP (one member per Member State) on the basis of their specific expertise or regulatory experience on the subjects covered within the scope of the BWP mandate.

Members

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

  • Marie-Christine Annequin
  • Lyudmil Antonov
  • John Joseph Borg
  • Vitalis Briedis
  • Alan Fauconnier
  • Nanna Aaby Kruse (Vice-Chair)
  • Barbora Ladinova
  • Maeve Lally
  • Tamara Mandusic Nazor
  • Helerin Margus
  • Margarida Menezes-Ferreira
  • Heidi Meyer
  • Ulrike Muus
  • Carlo Pini
  • Ilona G. Reischl
  • Jean-Louis Robert
  • Sol Ruiz (Chair)
  • Sirkku Saarela
  • Therese Solstad Saunders
  • Katalin Szalay
  • Magdalena Szymaniak
  • Mirela Tavakol
  • Marcos Timón
  • Asterios Tsiftsoglou
  • Michael Udell
  • Antonius Johannes van der Stappen
  • Maria Vassiliou
  • Mats Welin