PRAC members
The European Medicines Agency (EMA) publishes details of the members and alternates of its Pharmacovigilance Risk Assessment Committee (PRAC).
HumanPharmacovigilance
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.
In accordance with the committee rules of procedures, observers from non-EEA authorities with whom there is a confidentiality arrangement may attend the plenary meetings on regular basis. Attendance is reflected in the committee minutes as from 2024.
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 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
- Medicines Evaluation Board
- Address
- P. O. Box 8275, 3503 RG Utrecht, NETHERLANDS
- Downloads
Vice-chair
- Name
- Martin Huber
- Affiliation
- Federal Institute For Drugs And Medical Devices
- Address
- Kurt-Georg-Kiesinger-Allee 3, Plittersdorf, 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
- Austrian Federal Office For Safety In Health Care
- Address
- Traisengasse 5, Brigittenau, 1200 Vienna, AUSTRIA
- Downloads
Alternate
- Name
- Sonja Hrabcik
- Affiliation
- Austrian Federal Office For Safety In Health Care
- Address
- Traisengasse 5, Brigittenau, 1200 Vienna, AUSTRIA
- Downloads
Belgium
Member
- Name
- Jean-Michel Dogné
- Affiliation
- Universite de Namur
- Address
- Rue De Bruxelles 61, 5000 Namur, BELGIUM
- Downloads
Alternate
- Name
- Jo Robays
- Affiliation
- Federal Agency For Medicines And Health Products
- Address
- Galileelaan 5/03, 1210 Sint-Joost-Ten-Node, BELGIUM
- Downloads
Bulgaria
Member
- Name
- Maria Popova-Kiradjieva
- Affiliation
- Bulgarian Drug Agency
- Address
- Ul. Damyan Gruev 8, 1303 Sofia, BULGARIA
- Downloads
Alternate
- Name
- Julian Eftimov
- Affiliation
- Bulgarian Drug Agency
- Address
- Ul. Damyan Gruev 8, 1303 Sofia, BULGARIA
- Downloads
CROATIA
Member
- Name
- Petar Mas
- Affiliation
- Agency For Medicinal Products And Medical Devices Of Croatia
- Address
- Ksaverska Cesta 4, 10000 Zagreb, CROATIA
- Downloads
Alternate
- Name
- Barbara Kovacic Bytyqi
- Affiliation
- Agency For Medicinal Products And Medical Devices Of Croatia
- Address
- Ksaverska Cesta 4, 10000 Zagreb, CROATIA
- Downloads
Cyprus
Member
- Name
- Elena Kaisis
- Affiliation
- Pharmaceutical Services Ministry Of Health
- Address
- Polyfimou 15, Strovolos Industrial Area, 2033 Strovolos, CYPRUS
- Downloads
Alternate
- Name
- Panagiotis Psaras
- Affiliation
- Pharmaceutical Services Ministry Of Health
- Address
- Polyfimou 15, Strovolos Industrial Area, 2033 Strovolos, CYPRUS
- Downloads
CZECHIA
Member
- Name
- Eva Jirsová
- Affiliation
- State Institute For Drug Control
- Address
- Srobarova 48, 100 41 Prague 10, CZECHIA
- Downloads
Alternate
- Name
- Jana Lukacisinova
- Affiliation
- State Institute For Drug Control
- Address
- Srobarova 48, 100 41 Prague 10, CZECHIA
- Downloads
Denmark
Member
- Name
- Marie Louise Schougaard Christiansen
- Affiliation
- Danish Medicines Agency
- Address
- Axel Heides Gade 1, 2300 Copenhagen S, DENMARK
- Downloads
Alternate
- Name
- Karin Erneholm
- Affiliation
- Danish Medicines Agency
- Address
- Axel Heides Gade 1, 2300 Copenhagen S, DENMARK
- Downloads
Estonia
Member
- Name
- Maia Uusküla
- Affiliation
- State Agency Of Medicines
- Address
- Nooruse Tn 1, Tartu linn, 50411 Tartu Linn, ESTONIA
- Downloads
Alternate
- Name
- Krõõt Aab
- Affiliation
- State Agency Of Medicines
- Address
- Nooruse Tn 1, Tartu linn, 50411 Tartu Linn, ESTONIA
- Downloads
Finland
Member
- Name
- Kirsti Villikka
- Affiliation
- Finnish Medicines Agency
- Address
- Mannerheimintie 166, 00300 Helsinki, FINLAND
- Downloads
Alternate
- Name
- Kimmo Jaakkola
- Affiliation
- Finnish Medicines Agency
- Address
- P. O. Box 55, 00034 Helsinki, FINLAND
- Downloads
France
Member
- Name
- Tiphaine Vaillant
- Affiliation
- National Agency For The Safety Of Medicine And Health Products
- Address
- 143-147 Boulevard Anatole France, 93285 St Denis Cedex, FRANCE
- Downloads
Alternate
- Name
- Nathalie Gault
- Affiliation
- National Agency For The Safety Of Medicine And Health Products
- Address
- 143-147 Boulevard Anatole France, 93285 St Denis Cedex, FRANCE
- Downloads
Germany
Member
- Name
- Martin Huber
- Affiliation
- Federal Institute For Drugs And Medical Devices
- Address
- Kurt-Georg-Kiesinger-Allee 3, Plittersdorf, 53175 Bonn, GERMANY
- Downloads
Alternate
- Name
- Gabriele Maurer
- Affiliation
- Paul-Ehrlich-Institut
- Address
- Paul-Ehrlich-Strasse 51-59, Industriegebiet, 63225 Langen (Hesse), GERMANY
- Downloads
Greece
Member
- Name
- Sofia Trantza
- Affiliation
- National Organization For Medicines
- Address
- Mesogion Ave. 284, 155 62 Holargos, GREECE
- Downloads
Alternate
- Name
- Georgia Gkegka
- Affiliation
- National Organization For Medicines
- Address
- Mesogion Ave. 284, 155 62 Holargos, GREECE
- Downloads
Hungary
Member
- Name
- Julia Pallos
- Affiliation
- National Center For Public Health And Pharmacy
- Address
- PO Box 450, 1372 Budapest, HUNGARY
- Downloads
Alternate
- Name
- Melinda Palfi
- Affiliation
- National Center For Public Health And Pharmacy
- Address
- PO Box 450, 1372 Budapest, HUNGARY
- Downloads
Iceland
Member
- Name
- Guðrún Stefánsdóttir
- Affiliation
- Icelandic Medicines Agency
- Address
- Vinlandsleid 14, 113 Reykjavik, ICELAND
- Downloads
Alternate
- Name
- Guðrún Þengilsdóttir
- Affiliation
- Icelandic Medicines Agency
- Address
- Vinlandsleid 14, 113 Reykjavik, ICELAND
- Downloads
Ireland
Member
- Name
- Rhea Fitzgerald
- Affiliation
- Health Products Regulatory Authority
- Address
- Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, IRELAND
- Downloads
Alternate
- Name
- Eamon O Murchu
- Affiliation
- Health Products Regulatory Authority
- Address
- Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, IRELAND
- Downloads
Italy
Member
- Name
- Amelia Cupelli
- Affiliation
- Italian Medicines Agency
- Address
- Via Del Tritone 181, 00187, Rome, ITALY
- Downloads
Alternate
Awaiting Nomination.
Latvia
Member
- Name
- Zane Neikena
- Affiliation
- State Agency Of Medicines Of Latvia
- Address
- Jersikas Iela 15, 1003 Riga, LATVIA
- Downloads
Alternate
- Name
- Zane Stade
- Affiliation
- State Agency Of Medicines Of Latvia
- Address
- Jersikas Iela 15, 1003 Riga, LATVIA
- Downloads
Lithuania
Member
- Name
- Rugile Pilviniene
- Affiliation
- State Medicines Control Agency
- Address
- Savanoriu Pr. 220, Kauno M. Sav., 50196 Kaunas, LITHUANIA
- Downloads
Alternate
- Name
- Lina Seibokiene
- Affiliation
- State Medicines Control Agency
- Address
- Zirmunu G. 139a, Vilniaus M. Sav., 09120 Vilnius, LITHUANIA
- Downloads
Luxembourg
Member
- Name
- Nadine Petitpain
- Affiliation
- Centre Regional De Pharmacovigilance De Nancy
- Address
- 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034, 54035 Nancy Cedex, FRANCE
- Downloads
Alternate
- Name
- Anne-Cecile Vuillemin
- Affiliation
- Ministere De La Sante Division De La Pharmacie Et Des Medicaments
- Address
- 2a Rue Thomas Edison, 1445 Strassen, LUXEMBOURG
- Downloads
Malta
Member
- Name
- John Joseph Borg
- Affiliation
- Malta Medicines Authority
- Address
- Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
- Downloads
Alternate
- Name
- Benjamin Micallef
- Affiliation
- Malta Medicines Authority
- Address
- Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
- Downloads
Netherlands
Member
- Name
- Liana Martirosyan
- Affiliation
- Medicines Evaluation Board
- Address
- Graadt Van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS
- Downloads
Alternate
- Name
- Bianca Mulder
- Affiliation
- Medicines Evaluation Board
- Address
- Graadt Van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS
- Downloads
Norway
Member
- Name
- David Olsen
- Affiliation
- Norwegian Medical Products Agency
- Address
- P. O. Box 240, Skøyen, 0213 Oslo, NORWAY
- Downloads
Alternate
- Name
- Pernille Harg
- Affiliation
- Norwegian Medical Products Agency
- Address
- Grensesvingen 26, 0663 Oslo, NORWAY
- Downloads
Poland
Member
- Name
- Adam Przybylkowski
- Affiliation
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
- Address
- Ul. Aleje Jerozolimskie 181c, 02-222 Warsaw, POLAND
- Downloads
Alternate
- Name
- Katarzyna Ziolkowska
- Affiliation
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
- Address
- Ul. Aleje Jerozolimskie 181c, 02-222 Warsaw, POLAND
- Downloads
Portugal
Member
- Name
- Ana Sofia Diniz Martins
- Affiliation
- National Authority Of Medicines And Health Products
- Address
- Avenida Do Brasil 53, 1749-004 Lisbon, PORTUGAL
- Downloads
Alternate
- Name
- Carla Torre
- Affiliation
- National Authority Of Medicines And Health Products
- Address
- Avenida Do Brasil 53, 1749-004 Lisbon, PORTUGAL
- Downloads
Romania
Member
- Name
- Roxana Dondera
- Affiliation
- National Authority Of Medicines And Medical Devices
- Address
- Strada Mr. Av Sanatescu Stefan 48, 011478 Bucharest, ROMANIA
- Downloads
Alternate
- Name
- Irina Sandu
- Affiliation
- National Authority Of Medicines And Medical Devices
- Address
- Strada Mr. Av Sanatescu Stefan 48, 011478 Bucharest, ROMANIA
- Downloads
SLOVAKIA
Member
- Name
- Anna Mareková
- Affiliation
- State Institute For Drug Control
- Address
- Kvetna 11, Ruzinov, 821 08 Bratislava, SLOVAKIA
- Downloads
Alternate
- Name
- Miroslava Gocova
- Affiliation
- State Institute For Drug Control
- Address
- Kvetna 11, Ruzinov, 821 08 Bratislava, SLOVAKIA
- Downloads
Slovenia
Member
- Name
- Polona Golmajer
- Affiliation
- Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
- Address
- Slovenceva Ulica 22, 1000 Ljubljana, SLOVENIA
- Downloads
Alternate
- Name
- Marjetka Plementas
- Affiliation
- Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
- Address
- Slovenceva Ulica 22, 1000 Ljubljana, SLOVENIA
- Downloads
Spain
Member
- Name
- Maria del Pilar Rayon
- Affiliation
- The Spanish Agency Of Medicines And Medical Devices
- Address
- Edificio 8, Calle Campezo 1, Poligono Las Mercedes, 28022 Madrid, SPAIN
- Downloads
Alternate
- Name
- Monica Martinez Redondo
- Affiliation
- The Spanish Agency Of Medicines And Medical Devices
- Address
- Edificio 8, Calle Campezo 1, Poligono Las Mercedes, 28022 Madrid, SPAIN
- Downloads
Sweden
Member
- Name
- Ulla Wändel Liminga
- Affiliation
- Swedish Medical Products Agency
- Address
- Dag Hammarskjolds Vag 42, Uppsala Science Park, 752 37 Uppsala, SWEDEN
- Downloads
Alternate
- Name
- Mari Thorn
- Affiliation
- Swedish Medical Products Agency
- Address
- Dag Hammarskjolds Vag 42, Uppsala Science Park, 752 37 Uppsala, SWEDEN
- Downloads
Independent scientific experts nominated by the European Commission
- Name
- Tania Schink
- Affiliation
- Leibniz Institute for Prevention Research and Epidemiology - BIPS
- Address
- Achterstrasse 30, 28359 Bremen, GERMANY
- Downloads
- Name
- Maria Teresa Herdeiro
- Address
- Agra do Crasto, 3810-193 Aveiro, PORTUGAL
- Downloads
- Name
- Annalisa Capuano
- Affiliation
- Seconda Universita Di Napoli
- Address
- Vico Luigi De Crecchio 7, 80138, Naples, ITALY
- Downloads
- Name
- Hedvig Marie Egeland Nordeng
- Affiliation
- University Of Oslo
- Address
- P. O. Box 1068, 0316 Oslo, NORWAY
- Downloads
- Name
- Milou-Daniel Drici
- Address
- 30 Avenue de la Voie Romaine CS 51069, 06001 Nice, FRANCE
- Downloads
- Name
- Patricia McGettigan
- Affiliation
- Queen Mary University Of London
- Address
- Charterhouse Square, London, EC1M 6BQ, UNITED KINGDOM
- Downloads
Members representing patients' organisations nominated by the European Commission
Member
- Name
- Marko Korenjak
- Affiliation
- European Liver Patients Association
- Address
- Frederic De Renesselaan 57, 3800 Sint-Truiden, BELGIUM
- Downloads
Alternate
- Name
- Michal Rataj
- Address
- European Patients' Forum Chaussée d’Etterbeek 180 1040 Brussels BELGIUM
- Downloads
Members representing healthcare professionals nominated by the European Commission
Member
- Name
- Roberto Frontini
- Affiliation
- European Association of Hospital Pharmacists
- Address
- Priester Cuypersstraat 3, 1040 Etterbeek, BELGIUM
- Downloads
Alternate
- Name
- Salvatore Antonio Giuseppe Messana
- Affiliation
- Pharmaceutical Group Of The European Union
- Address
- Rue du Luxembourg 19-21, 1000 Bruxelles, BELGIUM
- Downloads