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 2022 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests (PDF/191.58 KB)
First published: 01/09/2021
Last updated: 15/11/2021
EMA/569288/2019 Rev. 2 -
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Dates of 2023 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests (PDF/146.3 KB)
First published: 14/06/2022
Last updated: 16/11/2022
EMA/569289/2019 Rev.4
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
- Caroline Auriche-Benichou
- Mario Miguel Coelho da Silva Rosa
- Pierre Demolis
- Hrefna Gudmundsdottir
- Sheila Killalea
- Andreas Kirisits
- Armin Koch
- 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
- Nicolas Beix
- Karoline Buhre
- Caoimhin Concannon
- Valentina Conti
- Bruno Delafont
- André Elferink
- Macarena Gajardo Alvarez
- Sara Galluzzo
- Ivana Haunerova
- Larissa Higgins
- Karin Janssen van Doorn
- Ebru Karakoc Madsen
- Johanna Lähteenvuo
- Anders Lignell
- João Manuel Lopes de Oliveira
- Serena Marchetti
- Clemens Mittmann
- Nathalie Morgensztejn
- Flora Musuamba Tshinanu
- Robert Nistico
- Martin Oleksiewicz
- Sif Ormarsdóttir
- Elina Rönnemaa
- Ingrid Schellens
- Anja Schiel
- Audrey Sultana
- Martin Walter
- Elisabeth Wischnitzki
- Hilke Zander