PRAC members
The European Medicines Agency (EMA) publishes details of the members and alternates of its Pharmacovigilance Risk Assessment Committee (PRAC).
The PRAC consists of:
- a chair, elected by serving PRAC members;
- one member and an alternate nominated by each of the EU Member States;
- one member and an alternate nominated by each of the EEA-EFTA States;
- six independent scientific experts nominated by the European Commission;
- one member and one alternate representing patients organisations nominated by the European Commission;
- one member and an alternate representing healthcare professionals nominated by the European Commission.
All members and alternates serve on the committee for a once renewable three year period.
List of members and alternates
The list includes each member's and alternate's:
- affiliation;
- curriculum vitae;
- declaration of interests and confidentiality undertaking.
For more information on EMA's policy on handling competing interests for committee members, see Handling competing interests.
For contact details, please refer to the affiliated organisations of individual committee members.
Members
Members nominated by the Member States
Independent scientific experts nominated by the European Commission
Members representing patients' organisations nominated by the European Commission
Members representing healthcare professionals nominated by the European Commission
Chair
- Name
- Sabine Straus
- Affiliation
- College ter Beoordeling van Geneesmiddelen
- Address
- P.O Box 8275, 3503 RG Utrecht, NETHERLANDS
- Downloads
Vice-chair
- Name
- Martin Huber
- Affiliation
- Bundesinstitut für Arzneimittel und Medizinprodukte
- Address
- Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
- Downloads
Members nominated by Member States
- Liechtenstein has delegated its task related to PRAC to another Member State, as foreseen
in Article 61a (2) of Regulation (EC) No 726/2004, as amended by Regulation (EU) No
1235/2010. It was mutually agreed that Austria will take over Liechtenstein’s tasks in
the PRAC.
Austria
Member
- Name
- Jan Neuhauser
- Affiliation
- BASG - Bundesamt für Sicherheit im Gesundheitswesen
- Address
- Traisengasse 5, A- 1200 Vienna, AUSTRIA
- Downloads
Alternate
- Name
- Sonja Hrabcik
- Affiliation
- BASG - Bundesamt für Sicherheit im Gesundheitswesen
- Address
- Traisengasse 5, A- 1200 Vienna, AUSTRIA
- Downloads
Belgium
Member
- Name
- Jean-Michel Dogné
- Affiliation
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - Agence Fédérale des Médicaments et des Produits de Santé
- Address
- Galileolaan 5/03, Avenue Galilée 5/03, B-1210 Brussel - Bruxelles, BELGIUM
- Downloads
Alternate
- Name
- Jo Robays
- Affiliation
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - Agence Fédérale des Médicaments et des Produits de Santé
- Address
- Galileolaan 5/03, Avenue Galilée 5/03, B-1210 Brussel - Bruxelles, BELGIUM
- Downloads
Bulgaria
Member
- Name
- Maria Popova-Kiradjieva
- Affiliation
- ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
- Address
- 8, Damyan Gruev str., 1303 Sofia, BULGARIA
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Alternate
- Name
- Julian Eftimov
- Affiliation
- ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
- Address
- 8, Damyan Gruev str., 1303 Sofia, BULGARIA
- Downloads
CROATIA
Member
- Name
- Nikica Mirošević Skvrce
- Affiliation
- Agencija za Lijekove i Medicinske Proizvode
- Address
- Ksaverska cesta 4, 10000 Zagreb, CROATIA
- Downloads
Alternate
- Name
- Željana Margan Koletić
- Affiliation
- Agencija za Lijekove i Medicinske Proizvode
- Address
- Ksaverska cesta 4, 10000 Zagreb, CROATIA
- Downloads
Cyprus
Member
- Name
- Elena Kaisis
- Affiliation
- Ministry of Health
- Address
- Pharmaceutical Services, 15 Polyphimou, Strovolos Industrial Area, 2033 Nicosia, CYPRUS
- Downloads
Alternate
- Name
- Panagiotis Psaras
- Affiliation
- ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΥΠΗΡΕΣΙΕΣ ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ
- Address
- Ministry Of Health, 15 Polyphimou, 2033 Lefkosia , CYPRUS
- Downloads
CZECHIA
Member
- Name
- Eva Jirsová
- Affiliation
- Státní ústav pro kontrolu léčiv
- Address
- Srobarova 48, 100 41 Prague, CZECHIA
- Downloads
Alternate
- Name
- Jana Lukacisinova
- Affiliation
- Státní ústav pro kontrolu léčiv
- Address
- Srobarova 48, 100 41 Prague, CZECHIA
- Downloads
Denmark
Member
- Name
- Anette Kirstine Stark
- Affiliation
- Danish Medicines Agency
- Address
- Axel Heides Gade 1, 2300 København S, DENMARK
- Downloads
Alternate
- Name
- Marie Louise Schougaard Christiansen
- Affiliation
- Danish Medicines Agency
- Address
- Axel Heides Gade 1, 2300 København S, DENMARK
- Downloads
Estonia
Member
- Name
- Maia Uusküla
- Affiliation
- Ravimiamet
- Address
- 1, Nooruse Street, 50411 Tartu, ESTONIA
- Downloads
Alternate
- Name
- Krõõt Aab
- Affiliation
- Ravimiamet
- Address
- 1, Nooruse Street, 50411 Tartu, ESTONIA
- Downloads
Finland
Member
- Name
- Kirsti Villikka
- Affiliation
- Lääkealan turvallisuus- ja kehittämiskeskus
- Address
- P.O. Box 55, FI-00034 FIMEA, Helsinki, FINLAND
- Downloads
Alternate
- Name
- Kimmo Jaakkola
- Affiliation
- Lääkealan turvallisuus- ja kehittämiskeskus
- Address
- P.O Box 55, FI-00034 Fimea, FINLAND
- Downloads
France
Member
- Name
- Tiphaine Vaillant
- Affiliation
- Agence nationale de sécurité du médicament et des produits de santé
- Address
- 143-147 Boulevard Anatole France, 93285 St Denis Cedex, FRANCE
- Downloads
Alternate
- Name
- Nathalie Gault
- Affiliation
- Agence nationale de sécurité du médicament et des produits de santé
- Address
- 143-147 Boulevard Anatole France, 93285 St Denis Cedex, FRANCE
- Downloads
Germany
Member
- Name
- Martin Huber
- Affiliation
- Bundesinstitut für Arzneimittel und Medizinprodukte
- Address
- Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
- Downloads
Alternate
- Name
- Brigitte Keller-Stanislawski
- Affiliation
- Paul-Ehrlich-Institut
- Address
- Paul-Ehrlich Straße 51-59, 63225 Langen, GERMANY
- Downloads
Greece
Member
- Name
- Sofia Trantza
- Affiliation
- National Organization for Medicines
- Address
- 284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
- Downloads
Alternate
- Name
- Georgia Gkegka
- Affiliation
- National Organization for Medicines
- Address
- 284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
- Downloads
Hungary
Member
- Name
- Julia Pallos
- Affiliation
- Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
- Address
- Szabolcs utca 33, 1135 Budapest, HUNGARY
- Downloads
Alternate
- Name
- Melinda Palfi
- Affiliation
- Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
- Address
- Szabolcs utca 33, 1135 Budapest, HUNGARY
- Downloads
Iceland
Member
- Name
- Guðrún Stefánsdóttir
- Affiliation
- Lyfjastofnun
- Address
- Vínlandsleið 14, IS-113 Reykjavík, ICELAND
- Downloads
Alternate
- Name
- Guðrún Þengilsdóttir
- Affiliation
- Lyfjastofnun
- Address
- Vínlandsleið 14, IS-113 Reykjavík, ICELAND
- Downloads
Ireland
Member
- Name
- Rhea Fitzgerald
- Affiliation
- An tÚdarás Rialála Táirgí Sláinte
- Address
- Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
- Downloads
Alternate
- Name
- Ronan Grimes
- Affiliation
- An tÚdarás Rialála Táirgí Sláinte
- Address
- Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
- Downloads
Italy
Member
- Name
- Amelia Cupelli
- Affiliation
- Agenzia Italiana del Farmaco
- Address
- Via del Tritone, 181, 00187, Roma, ITALY
- Downloads
Alternate
- Name
- Valentina Di Giovanni
- Affiliation
- Agenzia Italiana del Farmaco
- Address
- Via del Tritone, 181, 00187, Roma, ITALY
- Downloads
Latvia
Member
- Name
- Zane Neikena
- Affiliation
- Zāļu valsts aģentūra
- Address
- Jersikas iela 15, LV-1003 Riga, LATVIA
- Downloads
Alternate
- Name
- Zane Stade
- Affiliation
- Zāļu valsts aģentūra
- Address
- Jersikas iela 15, LV-1003 Riga, LATVIA
- Downloads
Lithuania
Member
- Name
- Rugile Pilviniene
- Affiliation
- State Medicines Control Agency under the Ministry of Health
- Address
- Savanoriu ave. 220, LT-50196 Kaunas, LITHUANIA
- Downloads
Alternate
- Name
- Lina Seibokiene
- Affiliation
- State Medicines Control Agency under the Ministry of Health
- Address
- Žirmūnų str.139A, LT-09120 Vilnius, LITHUANIA
- Downloads
Luxembourg
Member
- Name
- Nadine Petitpain
- Affiliation
- Centre Hospitalier Régional Universitaire
- Address
- Rue du Morvan, 54500 Vandoeuvre-Les-Nancy, FRANCE
- Downloads
Alternate
- Name
- Anne-Cecile Vuillemin
- Affiliation
- Ministère de la Santé
- Address
- 20, Rue de Bitbourg, L-1273 Luxembourg, LUXEMBOURG
- Downloads
Malta
Member
- Name
- John Joseph Borg
- Affiliation
- Awtorità dwar il-Mediċini
- Address
- Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
- Downloads
Alternate
- Name
- Benjamin Micallef
- Affiliation
- Awtorità dwar il-Mediċini
- Address
- Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
- Downloads
Netherlands
Member
- Name
- Menno van der Elst
- Affiliation
- College ter Beoordeling van Geneesmiddelen
- Address
- P.O Box 8275, 3503 RG Utrecht, NETHERLANDS
- Downloads
Alternate
- Name
- Liana Gross-Martirosyan
- Affiliation
- College ter Beoordeling van Geneesmiddelen
- Address
- P.O Box 8275, 3503 RG Utrecht, NETHERLANDS
- Downloads
Norway
Member
- Name
- David Olsen
- Affiliation
- Statens legemiddelverk
- Address
- Postboks 240, Skøyen, 0213 Oslo, NORWAY
- Downloads
Alternate
- Name
- Pernille Harg
- Affiliation
- Statens legemiddelverk
- Address
- Postboks 240, Skøyen, 0213 Oslo, NORWAY
- Downloads
Poland
Member
- Name
- Adam Przybylkowski
- Affiliation
- Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
- Address
- Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
- Downloads
Alternate
- Name
- Katarzyna Ziolkowska
- Affiliation
- Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
- Address
- Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
- Downloads
Portugal
Member
- Name
- Ana Sofia Diniz Martins
- Affiliation
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
- Address
- Parque de Saúde de Lisboa, Avenida do Brasil, 53, 1749-004 Lisboa, PORTUGAL
- Downloads
Alternate
- Name
- Inês Ribeiro-Vaz
- Affiliation
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
- Address
- Parque de Saúde de Lisboa, Avenida do Brasil, 53, 1749-004 Lisboa, PORTUGAL
- Downloads
Romania
Member
- Name
- Roxana Dondera
- Affiliation
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România
- Address
- Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, ROMANIA
- Downloads
Alternate
- Name
- Alexandra - Maria Spurni
- Affiliation
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România
- Address
- NATIONAL AGENCY FOR MEDICINES, 48, Av. Sanatescu St, sector 1, 011487 Bucharest, ROMANIA
- Downloads
SLOVAKIA
Member
- Name
- Anna Mareková
- Affiliation
- Štátny ústav pre kontrolu liečiv
- Address
- Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
- Downloads
Alternate
- Name
- Lucia Kuráková
- Affiliation
- Štátny ústav pre kontrolu liečiv
- Address
- Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
- Downloads
Slovenia
Member
- Name
- Polona Golmajer
- Affiliation
- Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
- Address
- Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
- Downloads
Alternate
- Name
- Milena Radoha-Bergoc
- Affiliation
- Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
- Address
- Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
- Downloads
Spain
Member
- Name
- Maria del Pilar Rayon
- Affiliation
- Agencia Espanola de Medicamentos y Productos Sanitarios
- Address
- Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, SPAIN
- Downloads
Alternate
- Name
- Monica Martinez Redondo
- Affiliation
- Agencia Espanola de Medicamentos y Productos Sanitarios
- Address
- Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, SPAIN
- Downloads
Sweden
Member
- Name
- Ulla Wändel Liminga
- Affiliation
- Läkemedelsverket
- Address
- Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
- Downloads
Alternate
- Name
- Mari Thorn
- Affiliation
- Läkemedelsverket
- Address
- Box 26, 751 03 Uppsala, SWEDEN
- Downloads
Independent scientific experts nominated by the European Commission
- Name
- Patricia McGettigan
- Address
- Queen Mary University of London, Clinical Pharmacology,, John Vane Building, Charterhouse Square, London, EC1M 6BQ, UNITED KINGDOM
- Downloads
- Name
- Address
- Name
- Annalisa Capuano
- Affiliation
- Second University of Naples
- Address
- Via Costantinopoli,16, 80138, Naples, ITALY
- Downloads
- Name
- Maria Teresa Herdeiro
- Affiliation
- iBiMED University of Aveiro
- Address
- Agra do Crasto, 3810-193 Aveiro, PORTUGAL
- Downloads
- Name
- Hedvig Marie Egeland Nordeng
- Affiliation
- University of Oslo
- Address
- P.O. Box 1068, Blindern, N-0316 Oslo, NORWAY
- Downloads
- Name
- Milou-Daniel Drici
- Affiliation
- Laboratoire de Pharmacologie-Bât. J4
- Address
- 30 Avenue de la Voie Romaine CS 51069, 06001 Nice, FRANCE
- Downloads
Members representing patients' organisations nominated by the European Commission
Member
- Name
- Declan Noone
- Affiliation
- European Haemophilia Consortium
- Address
- 10 rue de l'Industrie, 1000 Brussels, BELGIUM
- Downloads
Alternate
- Name
- Marko Korenjak
- Affiliation
- European Liver Patients Association (ELPA)
- Address
- Schuman Roundabout 2-4, Level 6, B-1040 Brussels, BELGIUM
- Downloads
Members representing healthcare professionals nominated by the European Commission
Member
- Name
- Roberto Frontini
- Affiliation
- European Association of Hospital Pharmacists
- Address
- Boulevard Brand Whitlock 87, 1200 Brussels, BELGIUM
- Downloads
Alternate
- Name
- Salvatore Antonio Giuseppe Messana
- Affiliation
- Pharmaceutical Group of the European Union (PGEU)
- Address
- Rue du Luxembourg 19-21, 1000 Bruxelles, BELGIUM
- Downloads