PRAC members
The European Medicines Agency (EMA) publishes details of the members and alternates of its Pharmacovigilance Risk Assessment Committee (PRAC).
Human
Pharmacovigilance
The PRAC consists of:
- a chair, elected by serving PRAC members;
- one member and an alternate appointed by each of the EU Member States;
- one member and an alternate appointed by each of the EEA-EFTA States;
- six independent scientific experts appointed by the European Commission;
- one member and one alternate representing patients organisations appointed by the European Commission;
- one member and an alternate representing healthcare professionals appointed by the European Commission.
All members and alternates serve on the committee for a three year period which may be prolonged once and thereafter renewed.
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 appointed by the Member States
Independent scientific experts appointed by the European Commission
Members representing patients' organisations appointed by the European Commission
Members representing healthcare professionals appointed by the European Commission
Chair
- Name
- Ulla Wändel Liminga
- Affiliation
- Swedish Medical Products Agency
- Address
- Dag Hammarskjolds Vag 42, Uppsala Science Park, 752 37 Uppsala, SWEDEN
- Downloads
Vice-chair
- Name
- Liana Martirosyan
- Affiliation
- Medicines Evaluation Board
- Address
- Graadt Van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS
- Downloads
Members appointed 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 Radowan
- 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
Awaiting Nomination.
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
- Veronika Macurova
- 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
- Terhi Lehtinen
- Affiliation
- Finnish Medicines Agency
- Address
- P.O. Box 55 , 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
- Zoubida Amimour
- 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
- Dirk Mentzer
- Affiliation
- Paul-Ehrlich-Institut
- Address
- Paul-Ehrlich-Strasse 51-59, Industriegebiet, 63225 Langen (Hesse), GERMANY
- Downloads
Greece
Member
- Name
- Georgia Gkegka
- Affiliation
- National Organization For Medicines
- Address
- Messogion Avenue 284, 155 62 Cholargos, GREECE
- Downloads
Alternate
- Name
- Maria Poulianiti
- Affiliation
- National Organization For Medicines
- Address
- Messogion Avenue 284, 155 62 Cholargos, GREECE
- Downloads
Hungary
Member
- Name
- Julia Pallos
- Affiliation
- National Centre For Public Health And Pharmacy
- Address
- PO Box 450, 1372 Budapest, HUNGARY
- Downloads
Alternate
- Name
- Melinda Palfi
- Affiliation
- National Centre 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
Awaiting Nomination.
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
- Name
- Emilio Clementi
- Address
- University of Milano, Dept Biomedical and Clinical Scences,Via GB Grassi 74, 20157 Milano, Italy
- Downloads
Latvia
Member
- Name
- Zane Neikena
- Affiliation
- State Agency Of Medicines
- Address
- Jersikas Iela 15, 1003 Riga, LATVIA
- Downloads
Alternate
- Name
- Diana Litenboka
- Affiliation
- State Agency Of Medicines
- 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
- Anne-Cecile Vuillemin
- Affiliation
- Ministry Of Health And Social Security
- Address
- 2a Rue Thomas Edison, 1445 Strassen, LUXEMBOURG
- Downloads
Alternate
- Name
- Magdalena Wielowieyska
- Affiliation
- Ministry Of Health And Social Security
- Address
- 20 Rue De Bitbourg, 1273 Luxembourg, 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 Of Romania
- Address
- Strada Mr. Av Sanatescu Stefan 48, 011478 Bucharest, ROMANIA
- Downloads
Alternate
- Name
- Irina Sandu
- Affiliation
- National Authority Of Medicines And Medical Devices Of Romania
- 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
- Spanish Agency Of Medicines And Medical Devices
- Address
- Edificio 8, Calle Campezo 1, Poligono Las Mercedes, 28022 Madrid, SPAIN
- Downloads
Alternate
- Name
- Maria Martinez Gonzalez
- Affiliation
- Spanish Agency Of Medicines And Medical Devices
- Address
- Edificio 8, Calle Campezo 1, Poligono Las Mercedes, 28022 Madrid, SPAIN
- Downloads
Sweden
Member
- Name
- Mari Thorn
- Affiliation
- Swedish Medical Products Agency
- Address
- Dag Hammarskjolds Vag 42, Uppsala Science Park, 752 37 Uppsala, SWEDEN
- Downloads
Alternate
- Name
- Karin Bolin
- Affiliation
- Swedish Medical Products Agency
- Address
- Box 26, 75103 Uppsala, SWEDEN
- Downloads
Independent scientific experts appointed by the European Commission
- Name
- Milou-Daniel Drici
- Address
- 30 Avenue de la Voie Romaine CS 51069, 06001 Nice, FRANCE
- Downloads
- Name
- Annalisa Capuano
- Address
- Via De Crecchio, 7 Naples
- Downloads
- Name
- Hedvig Marie Egeland Nordeng
- Affiliation
- Norwegian Institute Of Public Health
- Address
- P. O. Box 4404, 0403 Oslo, NORWAY
- Downloads
- Name
- Maria Teresa Herdeiro
- Address
- Universidade de Aveiro, Departamento de Ciências Médicas, iBiMED, Campus Universitário de Santiago, 3810-193 Aveiro, Portugal
- Downloads
- Name
- Anette Kirstine Stark
- Address
- Bispebjerg University Hospital, Bispebjergbakke 23, Copenhagen NV, 2400, Denmark
- Downloads
- Name
- Patricia McGettigan
- Affiliation
- Queen Mary University Of London
- Address
- Charterhouse Square, London, EC1M 6BQ, UNITED KINGDOM
- Downloads
Members representing patients' organisations appointed by the European Commission
Member
- Name
- YIANNOULA KOULLA
- Affiliation
- European Liver Patients Association
- Address
- Bus L6, Robert Schumanplein 2-4, 1040 Brussels, BELGIUM
- Downloads
Alternate
Members representing healthcare professionals appointed by the European Commission
Member
- Name
- Roberto Frontini
- Address
- Knaurstrasse, 6, Leipzig, 04155,Germany
- Downloads
Alternate
- Name
- Martin Votava
- Address
- Czech Medical Association of J.E. Purkynje, Sokolská 31, Prague 2, 12000, Czechia
- Downloads