Scientific Advice Working Party

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The Scientific Advice Working Party (SAWP) is a standing working party with the sole remit of providing scientific advice and protocol assistance. It was established by the Committee for Medicinal Products for Human Use (CHMP).

The SAWP is a multidisciplinary group, which comprises a chairperson, 28 members including three members of the Committee for Orphan Medicinal Products (COMP), one member of the Paediatric Committee (PDCO) and one member of the Committee for Advanced Therapies (CAT).

In the nomination process of the working party's members, a fair representation of the following areas of expertise is ensured:

  • non-clinical safety;
  • pharmacokinetics;
  • methodology and statistics;
  • therapeutic fields for which there are frequent requests or which are defined in the Annex of Regulation (EC) No 726/2004, such as cardiology, oncology, diabetes, neurodegenerative disorders and infectious diseases including human-immunodeficiency-virus (HIV) infection.

The SAWP coordinates the provision of scientific advice and protocol assistance. It brings an integrated view forward to the CHMP and the COMP on:

  • quality relating to the development of medicinal products;
  • non-clinical and clinical safety and efficacy relating to the development of medicinal products;
  • the significant benefit of orphan medicinal products.

The SAWP meets 11 times a year at the European Medicines Agency for a three-to-four-day meeting, generally two weeks before the monthly CHMP plenary meeting:

Mandate, rules of procedure and work programme

More information on the SAWP's responsibilities and composition is available in this document:

Members

Below are the current members and alternates of the SAWP. Their declarations of interests are available in the European expert list.

Members

  • Ewa Balkowiec Iskra
  • Ole Weis Bjerrum
  • Brigitte Bloechl-Daum
  • David Brown
  • Minne Casteels
  • Mario Miguel Coelho da Silva Rosa
  • Fernando de Andrés Trelles
  • Dieter Deforce
  • Pierre Demolis
  • Paolo Foggi
  • Christian Gartner
  • Kolbeinn Gudmundsson
  • Kirstine Moll Harboe
  • Robert James Hemmings (Chair)
  • Karl-Heinz Huemer
  • Brigitte Keller-Stanislawski
  • Sheila Killalea
  • Rune Kjeken
  • Armin Koch
  • Andrea Laslop
  • Romaldas Mačiulaitis
  • Armando Magrelli
  • Peter Mol
  • Alexandre Moreau
  • Jan Mueller-Berghaus
  • Koenraad Norga
  • Daniel O'Connor
  • Maura O'Donovan
  • Johannes Hendrikus Ovelgonne
  • Markku Pasanen
  • Mair Powell
  • Livia Puljak
  • Jens Reinhardt
  • Elmer Schabel
  • Jan Sjöberg
  • Olli Tenhunen
  • Kerstin Wickström

Alternates

  • Angeles Alonso Garcia
  • Adriana Andrić
  • Dina Apele-Freimane
  • Caroline Auriche-Benichou
  • Nicolas Beix
  • Carin Bergquist
  • Susan Cole
  • André Elferink
  • Blanca Garcia-Ochoa
  • Hrefna Gudmundsdottir
  • Marion Haberkamp
  • Walter Janssens
  • Karin Janssen van Doorn
  • Filip Josephson
  • Andreas Kirisits
  • Juha Kolehmainen
  • Katerina Kopeckova
  • Stephan Lehr
  • Herve Le Louet
  • João Manuel Lopes de Oliveira
  • Serena Marchetti
  • Dana Gabriela Marin
  • James McBlane
  • Jeanette McCallion
  • Martin Mengel
  • Susan Morgan
  • Odoardo Maria Olimpieri
  • Karri Penttila
  • Anja Schiel
  • Audrey Sultana
  • Johanna Wernsperger
  • Mogens Westergaard
  • Elena Wolff-Holz

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