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:
- 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:
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Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
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Dates of 2019 Scientific Advice Working Party (SAWP) meetings and submission deadlines for scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests
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Dates of 2018 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:
Members
Below are the current members and alternates of the SAWP. Their declarations of interests are available in the European expert list.
Members
Members
- Dina Apele-Freimane
- Ewa Balkowiec Iskra
- Carin Bergquist
- Ole Weis Bjerrum
- David Brown
- Minne Casteels
- Mario Miguel Coelho da Silva Rosa
- Fernando de Andrés Trelles
- Dieter Deforce
- Pierre Demolis
- Paolo Foggi
- Kolbeinn Gudmundsson
- Kirstine Moll Harboe
- Karl-Heinz Huemer
- Filip Josephson
- Brigitte Keller-Stanislawski
- Sheila Killalea
- Andreas Kirisits
- Rune Kjeken
- Armin Koch
- Andrea Laslop
- Romaldas Mačiulaitis
- Armando Magrelli
- Eva Malikova
- Peter Mol
- Alexandre Moreau
- Jan Mueller-Berghaus
- Daniel O'Connor
- Maura O'Donovan
- Johannes Hendrikus Ovelgonne
- Markku Pasanen
- Mair Powell
- Livia Puljak
- Jens Reinhardt
- Elmer Schabel
- Anja Schiel (Chair)
- Brigitte Schwarzer-Daum
- Olli Tenhunen
- Kerstin Wickström
Alternates
- Angeles Alonso Garcia
- Adriana Andrić
- Caroline Auriche-Benichou
- Nicolas Beix
- Susan Cole
- André Elferink
- Blanca Garcia-Ochoa
- Hrefna Gudmundsdottir
- Marion Haberkamp
- Walter Janssens
- Karin Janssen van Doorn
- Juha Kolehmainen
- Finbarr Patrick Leacy
- Stephan Lehr
- João Manuel Lopes de Oliveira
- Serena Marchetti
- Dana Gabriela Marin
- Darius Matusevicius
- James McBlane
- Jeanette McCallion
- Cristina Migali
- Susan Morgan
- Flora Musuamba Tshinanu
- Robert Nistico
- Karri Penttila
- Elina Rönnemaa
- Audrey Sultana
- Linda Trauffler
- Kristian Wennmalm
- Johanna Wernsperger
- Mogens Westergaard
- Elena Wolff-Holz
- Joerg Zinserling