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

  • Angeles Alonso Garcia
  • Brigitte Bloechl-Daum
  • David Brown
  • Torbjorn Callreus
  • Minne Casteels
  • Fernando de Andrés Trelles
  • Dieter Deforce
  • Pierre Demolis
  • Jens Ersbøll
  • Paolo Foggi
  • Kolbeinn Gudmundsson
  • Robert James Hemmings (Chair)
  • Karl-Heinz Huemer
  • Sheila Killalea
  • Armin Koch
  • Thomas Lang
  • Andrea Laslop
  • Romaldas Mačiulaitis
  • Armando Magrelli
  • Peter Mol
  • Jan Mueller-Berghaus
  • Daniel O'Connor
  • Johannes Hendrikus Ovelgonne
  • Luca Pani
  • Markku Pasanen
  • Mair Powell
  • Mario Miguel Rosa
  • Elmer Schabel
  • Jan Sjöberg
  • Olli Tenhunen
  • Ferran Torres
  • Kerstin Wickström

Alternates

  • Caroline Auriche-Benichou
  • Carin Bergquist
  • André Elferink
  • Blanca Garcia-Ochoa
  • Christian Gartner
  • Marion Haberkamp
  • Kirstine Moll Harboe
  • Helgi Helgason
  • Walter Janssens
  • Karin Janssen van Doorn
  • Filip Josephson
  • Peter Kiely
  • Andreas Kirisits
  • Juha Kolehmainen
  • João Manuel Lopes de Oliveira
  • Valentina Mantua
  • Martin Mengel
  • Alexandre Moreau
  • Susan Morgan
  • Amany N. El-Gazayerly
  • Martin Erik Nyeland
  • Odoardo Maria Olimpieri
  • Jens Reinhardt
  • Jonathan Sisson

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