Committees

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
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Vice-chair

Name
Martin Huber
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
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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
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Alternate

Name
Sonja Hrabcik
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, AUSTRIA
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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
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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
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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
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CROATIA

Member

Name
Nikica Mirošević Skvrce
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
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Alternate

Name
Željana Margan Koletić
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
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Cyprus

Member

Name
Elena Kaisis
Affiliation
Ministry of Health
Address
Pharmaceutical Services, 15 Polyphimou, Strovolos Industrial Area, 2033 Nicosia, CYPRUS
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Alternate

Name
Panagiotis Psaras
Affiliation
ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΥΠΗΡΕΣΙΕΣ ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ
Address
Ministry Of Health, 15 Polyphimou, 2033 Lefkosia , CYPRUS
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CZECHIA

Member

Name
Eva Jirsová
Affiliation
Státní ústav pro kontrolu léčiv
Address
Srobarova 48, 100 41 Prague, CZECHIA
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Alternate

Name
Jana Lukacisinova
Affiliation
Státní ústav pro kontrolu léčiv
Address
Srobarova 48, 100 41 Prague, CZECHIA
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Denmark

Member

Name
Anette Kirstine Stark
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
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Alternate

Name
Marie Louise Schougaard Christiansen
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
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Estonia

Member

Name
Maia Uusküla
Affiliation
Ravimiamet
Address
1, Nooruse Street, 50411 Tartu, ESTONIA
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Alternate

Name
Krõõt Aab
Affiliation
Ravimiamet
Address
1, Nooruse Street, 50411 Tartu, ESTONIA
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Finland

Member

Name
Kirsti Villikka
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O. Box 55, FI-00034 FIMEA, Helsinki, FINLAND
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Alternate

Name
Kimmo Jaakkola
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O Box 55, FI-00034 Fimea, FINLAND
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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
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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
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Germany

Member

Name
Martin Huber
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
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Alternate

Name
Gabriele Maurer
Affiliation
Paul-Ehrlich-Institut
Address
Paul-Ehrlich-Straße 51-56, 63225 Langen, GERMANY
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Greece

Member

Name
Sofia Trantza
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
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Alternate

Name
Georgia Gkegka
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
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Hungary

Member

Name
Julia Pallos
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Szabolcs utca 33, 1135 Budapest, HUNGARY
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Alternate

Name
Melinda Palfi
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Szabolcs utca 33, 1135 Budapest, HUNGARY
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Iceland

Member

Name
Guðrún Stefánsdóttir
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
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Alternate

Name
Guðrún Þengilsdóttir
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
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Ireland

Member

Name
Rhea Fitzgerald
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
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Alternate

Name
Ronan Grimes
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
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Italy

Member

Name
Amelia Cupelli
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, ITALY
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Alternate

Name
Valentina Di Giovanni
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, ITALY
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Latvia

Member

Name
Zane Neikena
Affiliation
Zāļu valsts aģentūra
Address
Jersikas iela 15, LV-1003 Riga, LATVIA
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Alternate

Name
Zane Stade
Affiliation
Zāļu valsts aģentūra
Address
Jersikas iela 15, LV-1003 Riga, LATVIA
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Lithuania

Member

Name
Rugile Pilviniene
Affiliation
State Medicines Control Agency under the Ministry of Health
Address
Savanoriu ave. 220, LT-50196 Kaunas, LITHUANIA
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Alternate

Name
Lina Seibokiene
Affiliation
State Medicines Control Agency under the Ministry of Health
Address
Žirmūnų str.139A, LT-09120 Vilnius, LITHUANIA
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Luxembourg

Member

Name
Nadine Petitpain
Affiliation
Centre Hospitalier Régional Universitaire
Address
Rue du Morvan, 54500 Vandoeuvre-Les-Nancy, FRANCE
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Alternate

Name
Anne-Cecile Vuillemin
Affiliation
Ministère de la Santé
Address
20, Rue de Bitbourg, L-1273 Luxembourg, LUXEMBOURG
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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
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Alternate

Name
Benjamin Micallef
Affiliation
Awtorità dwar il-Mediċini
Address
Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
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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
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Alternate

Name
Pernille Harg
Affiliation
Statens legemiddelverk
Address
Postboks 240, Skøyen, 0213 Oslo, NORWAY
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Poland

Member

Name
Adam Przybylkowski
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
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Alternate

Name
Katarzyna Ziolkowska
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
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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
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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
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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
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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
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SLOVAKIA

Member

Name
Anna Mareková
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
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Alternate

Name
Lucia Kuráková
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
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Slovenia

Member

Name
Polona Golmajer
Affiliation
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
Address
Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
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Alternate

Name
Milena Radoha-Bergoc
Affiliation
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
Address
Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
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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
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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
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Sweden

Member

Name
Ulla Wändel Liminga
Affiliation
Läkemedelsverket
Address
Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
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Alternate

Name
Mari Thorn
Affiliation
Läkemedelsverket
Address
Box 26, 751 03 Uppsala, SWEDEN
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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
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Name
Maria Teresa Herdeiro
Affiliation
iBiMED University of Aveiro
Address
Agra do Crasto, 3810-193 Aveiro, PORTUGAL
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Name
Hedvig Marie Egeland Nordeng
Affiliation
University of Oslo
Address
P.O. Box 1068, Blindern, N-0316 Oslo, NORWAY
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Name
Milou-Daniel Drici
Affiliation
Laboratoire de Pharmacologie-Bât. J4
Address
30 Avenue de la Voie Romaine CS 51069, 06001 Nice, FRANCE
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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
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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
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Alternate

Name
Salvatore Antonio Giuseppe Messana
Affiliation
Pharmaceutical Group of the European Union (PGEU)
Address
Rue du Luxembourg 19-21, 1000 Bruxelles, BELGIUM
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