Scientific Advice Working Party The Scientific Advice Working...

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, 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 726/2004External link icon, 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:
The dates of 2014 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel EMA-health-technology-assessment requests
Mandate, rules of procedure and work programme
More information on the SAWP's responsibilities and composition is available in this document:
Mandate, objectives and rules of procedure of the SAWP
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
Minne Casteels
Fernando de Andrés Trelles
Dieter Deforce
Pierre Demolis
Jens Ersbøll
Kolbeinn Gudmundsson
Robert James Hemmings (Chair)
Karl-Heinz Huemer
Bertil Jonsson (Vice-Chair)
Sheila Killalea
Armin Koch
Thomas Lang
Andrea Laslop
Armando Magrelli
Peter Mol
Jan Mueller-Berghaus
Johannes H. Ovelgönne
Ira Palminger Hallen
Luca Pani
Markku Pasanen
Mair Powell
Mario Miguel Rosa
Elmer Schabel
Olli Tenhunen
Ferran Torres
Kerstin Westermark
Kerstin Wickström
Alternates
Caroline Auriche-Benichou
Norbert Benda
Carin Bergquist
Thalia Marie Blicher
André Elferink
Paolo Foggi
Blanca Garcia-Ochoa
Christian Gartner
Marion Haberkamp
Helgi Helgason
Walter Janssens
Peter Kiely
Andreas Kirisits
Juha Kolehmainen
Marleen Laloup
João Manuel Lopes de Oliveira
Valentina Mantua
Alexandre Moreau
Susan Morgan
Amany N. El-Gazayerly
Nithyanandan Nagercoil
Jens Reinhardt
Jan Sjöberg