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:

Dates of 2024 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests

Reference Number: EMA/569290/2019 Rev.2

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

Reference Number: 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:

Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)

AdoptedReference Number: EMEA/CHMP/SAWP/69686/04 Rev.17

Members

Below are the current members and alternates of the SAWP. Their declarations of interests are available in the European expert list.

Members

• Dina Apele-Freimane
• Caroline Auriche-Benichou
• Ewa Balkowiec Iskra
• Carin Bergquist
• Minne Casteels
• Marie Louise Schougaard Christiansen
• Mario Miguel Coelho da Silva Rosa
• Dieter Deforce
• Pierre Demolis (Vice-Chair)
• André Elferink
• Paolo Foggi (Chair)
• Hrefna Gudmundsdottir
• Olga Kholmanskikh
• Andreas Kirisits
• Rune Kjeken
• Armin Koch
• Juha Kolehmainen
• Andrea Laslop
• Mette Linnert Jensen
• Cristina Migali
• Alexandre Moreau
• Torsten Holm Nielsen
• Johannes Hendrikus Ovelgonne
• Gabriella Passacquale
• Karri Penttila
• Vilma Petrikaite
• Mair Powell
• Livia Puljak
• Jens Reinhardt
• Rosalía Ruano Camps
• Elmer Schabel
• Brigitte Schwarzer-Daum
• Olli Tenhunen
• Kristian Wennmalm
• Joerg Zinserling

Alternates

• Silvijus Abramavicius
• Lukas Malte Aguirre Davila
• Adriana Ammassari
• Mikael Andersson
• Elina Asikanius
• Nicolas Beix
• Karoline Buhre
• Caoimhin Concannon
• Valentina Conti
• Macarena Gajardo Alvarez
• Karin Janssen van Doorn
• Johanna Lähteenvuo
• Anders Lignell
• João Manuel Lopes de Oliveira
• Serena Marchetti
• Heidi Mestl
• Clemens Mittmann
• Nathalie Morgensztejn
• Flora Musuamba Tshinanu
• Martin Oleksiewicz
• Sif Ormarsdóttir
• Dagmar Pospisilova
• Elina Rönnemaa
• Anja Schiel
• Viktoriia Starokozhko
• Audrey Sultana
• Martin Walter
• Elisabeth Wischnitzki
• Hilke Zander