Scientific Advice Working Party

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, 36 members including three members of the Committee for Orphan Medicinal Products (COMP), three members of the Paediatric Committee (PDCO), three members of the Committee for Advanced Therapies (CAT) and one member of the Pharmacovigilance Risk Assessment Committee (PRAC).

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:

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:

Members

Members

  • Ewa Balkowiec Iskra
  • Carin Bergquist
  • Ole Weis Bjerrum
  • Minne Casteels
  • Mario Miguel Coelho da Silva Rosa
  • Fernando de Andrés Trelles
  • Dieter Deforce
  • Pierre Demolis
  • Paolo Foggi (Chair)
  • Sara Galluzzo
  • Hrefna Gudmundsdottir
  • Karl-Heinz Huemer
  • Brigitte Keller-Stanislawski
  • Sheila Killalea
  • Andreas Kirisits
  • Rune Kjeken
  • Armin Koch
  • Juha Kolehmainen
  • Andrea Laslop
  • Mette Linnert Jensen
  • Romaldas Mačiulaitis
  • Cristina Migali
  • Peter Mol
  • Alexandre Moreau
  • Johannes Hendrikus Ovelgonne
  • Karri Penttila
  • Mair Powell
  • Livia Puljak
  • Jens Reinhardt
  • Rosalía Ruano Camps
  • Elmer Schabel
  • Brigitte Schwarzer-Daum
  • Olli Tenhunen
  • Anna Vikerfors
  • Kristian Wennmalm
  • Kerstin Wickström
  • Joerg Zinserling

Alternates

  • Silvijus Abramavicius
  • Adriana Ammassari
  • Mikael Andersson
  • Dina Apele-Freimane
  • Caroline Auriche-Benichou
  • Nicolas Beix
  • Karoline Buhre
  • Bruno Delafont
  • André Elferink
  • Ivana Haunerova
  • Larissa Higgins
  • Karin Janssen van Doorn
  • Johanna Lähteenvuo
  • Finbarr Leacy
  • Anders Lignell
  • João Manuel Lopes de Oliveira
  • Armando Magrelli
  • Serena Marchetti
  • Clemens Mittmann
  • Jan Mueller-Berghaus
  • Flora Musuamba Tshinanu
  • Robert Nistico
  • Maura O'Donovan
  • Martin Oleksiewicz
  • Sif Ormarsdóttir
  • Elina Rönnemaa
  • Ingrid Schellens
  • Anja Schiel
  • Audrey Sultana
  • Linda Trauffler
  • Johanna Wernsperger
  • Mogens Westergaard
  • Elena Wolff-Holz