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 Iceland and Norway;
  • 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:

  • contact details;
  • 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.

Jump to section:

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
Tel.
+31 88 2248000
Fax.
+31 88 2248001
Email
nlhphar@cbg-meb.nl
Downloads

Vice-chair

Name
Martin Huber
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
Tel.
+49 228 2074218
Fax.
+49 228 2073515
Email
martin.huber@bfarm.de
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
Tel.
+43 50555 36566
Fax.
+43 50555 36559
Email
jan.neuhauser@ages.at
Downloads

Alternate

Name
Sonja Hrabcik
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, AUSTRIA
Tel.
+43 50 55536245
Fax.
+43 50 55536207
Email
sonja.hrabcik@ages.at
Downloads

Belgium

Member

Name
Jean-Michel Dogné
Affiliation
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - Agence Fédérale des Médicaments et des Produits de Santé
Address
EUROSTATION gebouw, blok 2, Victor Hortaplein 40 / 40, Bâtiment EUROSTATION, bloc 2, place Victor Horta, 40/ 40, B-1060 Brussel - Bruxelles, BELGIUM
Tel.
+32 81 724289
Fax.
+32 81 724299
Email
jean-michel.dogne@unamur.be
Downloads

Alternate

Name
Laurence de Fays
Affiliation
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - Agence Fédérale des Médicaments et des Produits de Santé
Address
EUROSTATION gebouw, blok 2, Victor Hortaplein 40 / 40, Bâtiment EUROSTATION, bloc 2, place Victor Horta, 40/ 40, B-1060 Brussel - Bruxelles, BELGIUM
Tel.
+32 252 84405
Fax.
+32 2 5284001
Email
laurence.defays@fagg-afmps.be
Downloads

Bulgaria

Member

Name
Maria Popova-Kiradjieva
Affiliation
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Address
8, Damyan Gruev str., 1303 Sofia, BULGARIA
Tel.
+359 2 8903487
Fax.
+359 2 8903434
Email
maria.popova@bda.bg
Downloads

Alternate

Name
Julian Eftimov
Affiliation
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Address
8, Damyan Gruev str., 1303 Sofia, BULGARIA
Tel.
+359 2 8903417
Fax.
+359 2 8903434
Email
julian.eftimov@bda.bg
Downloads

CROATIA

Member

Name
Nikica Mirošević Skvrce
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
Tel.
+385 1 4884334
Fax.
+385 1 4884100
Email
nikica.mirosevic@halmed.hr
Downloads

Alternate

Name
Željana Margan Koletić
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
Tel.
+385 1488 4357
Fax.
+385 1488 4119
Email
zeljana.margan@halmed.hr
Downloads

Cyprus

Member

Name
Panagiotis Psaras
Affiliation
ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΥΠΗΡΕΣΙΕΣ ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ
Address
Ministry Of Health, 15 Polyphimou, 2033 Lefkosia , CYPRUS
Tel.
+357 2260 8694
Email
ppsaras@phs.moh.gov.cy
Downloads

Alternate

Name
Christina Sylvia Chrysostomou
Affiliation
ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΥΠΗΡΕΣΙΕΣ ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ
Address
Ministry Of Health, 15 Polyphimou, 2033 Lefkosia , CYPRUS
Tel.
+357 2260 8673
Fax.
+357 2260 8669
Email
cchrisostomou@phs.moh.gov.cy
Downloads

CZECHIA

Member

Name
Eva Jirsová
Affiliation
Státní ústav pro kontrolu léčiv
Address
Srobarova 48, 100 41 Prague, CZECHIA
Tel.
+420 272 185729
Fax.
+420 272 185816
Email
eva.jirsova@sukl.cz
Downloads

Alternate

Name
Jana Lukacisinova
Affiliation
Státní ústav pro kontrolu léčiv
Address
Srobarova 48, 100 41 Prague, CZECHIA
Tel.
+420 272 185 360
Email
jana.lukacisinova@sukl.cz
Downloads

Denmark

Member

Name
Anette Kirstine Stark
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44889595
Fax.
+45 44889599
Email
AKST@dkma.dk
Downloads

Alternate

Name
Hans Christian Siersted
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44889595
Fax.
+45 44889599
Email
HACS@dkma.dk
Downloads

Estonia

Member

Name
Maia Uusküla
Affiliation
Ravimiamet
Address
1, Nooruse Street, 50411 Tartu, ESTONIA
Tel.
+372 7 374140
Fax.
+372 7 374142
Email
maia.uuskula@ravimiamet.ee
Downloads

Alternate

Name
Katrin Kiisk
Affiliation
Ravimiamet
Address
1, Nooruse Street, 50411 Tartu, ESTONIA
Tel.
+372 7374140
Fax.
+372 7374142
Email
katrin.kiisk@ravimiamet.ee
Downloads

Finland

Member

Name
Kirsti Villikka
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O. Box 55, FI-00034 FIMEA, Helsinki, FINLAND
Tel.
+358 29 5223455
Fax.
+358 29 5223009
Email
kirsti.villikka@fimea.fi
Downloads

Alternate

Name
Kimmo Jaakkola
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O Box 55, FI-00034 Fimea, FINLAND
Tel.
+358 29 5223336
Email
kimmo.jaakkola@fimea.fi
Downloads

France

Member

Name
Adrien Inoubli
Affiliation
Agence nationale de sécurité du médicament et des produits de santé
Address
143-147 Bvd Anatole France, 93285 Saint-Denis Cedex, FRANCE
Tel.
+33 155 874308
Email
adrien.inoubli@ansm.sante.fr
Downloads

Alternate

Name
Tiphaine Vaillant
Affiliation
Agence nationale de sécurité du médicament et des produits de santé
Address
143-147 Bvd Anatole France, 93285 Saint-Denis Cedex, FRANCE
Tel.
+33 15587 4295
Email
tiphaine.vaillant@ansm.sante.fr
Downloads

Germany

Member

Name
Martin Huber
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
Tel.
+49 228 2074218
Fax.
+49 228 2073515
Email
martin.huber@bfarm.de
Downloads

Alternate

Name
Brigitte Keller-Stanislawski
Affiliation
Paul-Ehrlich-Institut
Address
Paul-Ehrlich Straße 51-59, 63225 Langen, GERMANY
Tel.
+49 6103 771010
Fax.
+49 6103 771263
Email
brigitte.keller-stanislawski@pei.de
Downloads

Greece

Member

Name
Agni Kapou
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
Tel.
+30 21 32040547
Fax.
+30 21 06549585
Email
akapou@eof.gr
Downloads

Alternate

Name
Sofia Trantza
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
Tel.
+30 21320 40446
Fax.
+30 210 6545535
Email
strantza@eof.gr
Downloads

Hungary

Member

Name
Julia Pallos
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Zrínyi U. 3, 1051 Budapest, HUNGARY
Tel.
+36 1 8869316
Fax.
+36 1 8869472
Email
pallos.julia@ogyei.gov.hu
Downloads

Alternate

Name
Melinda Palfi
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Zrínyi U. 3, 1051 Budapest, HUNGARY
Tel.
+36 1 8869300159
Fax.
+36 1 8869472
Email
palfi.melinda@ogyei.gov.hu
Downloads

Iceland

Member

Name
Guðrún Stefánsdóttir
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
Tel.
+354 5 202100
Fax.
+354 5 612170
Email
gudrun.stefansdottir@ima.is
Downloads

Alternate

Awaiting Nomination.

Ireland

Member

Name
Rhea Fitzgerald
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
Tel.
+35 316 764971
Fax.
+35 316 764061
Email
rhea.fitzgerald@hpra.ie
Downloads

Alternate

Name
Ronan Grimes
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
Tel.
+353 1 6764971
Fax.
+353 1 6767836
Email
ronan.grimes@hpra.ie
Downloads

Italy

Member

Name
Amelia Cupelli
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, ITALY
Tel.
+39 06 59784311
Fax.
+39 06 59784142
Email
a.cupelli@aifa.gov.it
Downloads

Alternate

Name
Ilaria Baldelli
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, ITALY
Tel.
+39 06597 84333
Fax.
+39 06597 84142
Email
i.baldelli@aifa.gov.it
Downloads

Latvia

Member

Name
Zane Neikena
Affiliation
Zāļu valsts aģentūra
Address
Jersikas iela 15, LV-1003 Riga, LATVIA
Tel.
+371 670 78438
Fax.
+371 670 78428
Email
zane.neikena@zva.gov.lv
Downloads

Alternate

Name
Zane Stade
Affiliation
Zāļu valsts aģentūra
Address
Jersikas iela 15, LV-1003 Riga, LATVIA
Tel.
+371 670 78438
Fax.
+371 670 78428
Email
zane.stade@zva.gov.lv
Downloads

Lithuania

Member

Name
Rugile Pilviniene
Affiliation
State Medicines Control Agency under the Ministry of Health
Address
Savanoriu ave. 220, LT-50196 Kaunas, LITHUANIA
Tel.
+370 3 7408407
Fax.
+370 3 7408407
Email
rugilepilviniene@vvkt.lt
Downloads

Alternate

Name
Ruta Kerpauskiene
Affiliation
State Medicines Control Agency under the Ministry of Health
Address
Savanoriu ave. 220, LT-50196 Kaunas, LITHUANIA
Email
RutaKerpauskiene@vvkt.lt
Downloads

Luxembourg

Member

Name
Nadine Petitpain
Affiliation
Centre Hospitalier Régional Universitaire
Address
Rue du Morvan, 54500 Vandoeuvre-Les-Nancy, FRANCE
Tel.
+33 3 83656090
Email
n.petitpain@chru-nancy.fr
Downloads

Alternate

Name
Anne-Cecile Vuillemin
Affiliation
Ministère de la Santé
Address
20, Rue de Bitbourg, L-1273 Luxembourg, LUXEMBOURG
Tel.
+352 2478 5649
Fax.
+352 2620 0147
Email
anne-cecile.vuillemin@ms.etat.lu
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
Tel.
+356 23 439129
Fax.
+356 23 439158
Email
john-joseph.borg@gov.mt
Downloads

Alternate

Name
Benjamin Micallef
Affiliation
Awtorità dwar il-Mediċini
Address
Sir Temi Zammit Buildings, Malta Life Sciences Park, SGN 3000 San Gwann, MALTA
Tel.
+356 2343 9125
Fax.
+356 2343 9161
Email
benjamin.micallef@gov.mt
Downloads

Netherlands

Member

Name
Menno van der Elst
Affiliation
College ter Beoordeling van Geneesmiddelen
Address
P.O Box 8275, 3503 RG Utrecht, NETHERLANDS
Tel.
+31 88 2248000
Fax.
+31 88 2248001
Email
nlhphar@cbg-meb.nl
Downloads

Alternate

Name
Liana Gross-Martirosyan
Affiliation
College ter Beoordeling van Geneesmiddelen
Address
P.O Box 8275, 3503 RG Utrecht, NETHERLANDS
Tel.
+31 088 2248389
Email
nl-h.pharmacovigilance@nl-h.eudra.org
Downloads

Norway

Member

Name
David Olsen
Affiliation
Statens legemiddelverk
Address
Postboks 240, Skøyen, 0213 Oslo, NORWAY
Tel.
+47 2216 8436
Email
david.benee.olsen@noma.no
Downloads

Alternate

Name
Pernille Harg
Affiliation
Statens legemiddelverk
Address
Postboks 240, Skøyen, 0213 Oslo, NORWAY
Tel.
+47 22 897582
Email
pernille.harg@noma.no
Downloads

Poland

Member

Name
Adam Przybylkowski
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
Tel.
+4822 8262 116
Fax.
+4822 8262 116
Email
aprzybylkowski@wum.edu.pl
Downloads

Alternate

Name
Katarzyna Ziolkowska
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
Tel.
+48 22 4921184
Fax.
+48 22 4921109
Email
katarzyna.ziolkowska@urpl.gov.pl
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
Tel.
+351 21798 7292
Email
ana.martins@infarmed.pt
Downloads

Alternate

Name
Marcia Sofia Sanches de Castro Lopes Silva
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
Tel.
+351 217 985271
Fax.
+351 217 987397
Email
marcia.silva@infarmed.pt
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
Tel.
+402 13171115 385
Email
roxana.dondera@anm.ro
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
Tel.
+40 21 3171102
Email
alexandra.spurni@anm.ro
Downloads

SLOVAKIA

Member

Name
Michal Radik
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
Tel.
+421 2 50701210
Email
michal.radik@sukl.sk
Downloads

Alternate

Name
Marek Juracka
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
Email
marek.juracka@sukl.sk
Downloads

Slovenia

Member

Name
Gabriela Jazbec
Affiliation
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
Address
Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
Tel.
+386 8 2000500
Fax.
+386 8 2000510
Email
gabriela.jazbec@jazmp.si
Downloads

Alternate

Name
Jasmina Klopcic
Affiliation
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
Address
Slovenceva ulica 22, 1000 Ljubljana, SLOVENIA
Tel.
+386 8 2000500
Fax.
+386 8 2000 510
Email
jasmina.klopcic@jazmp.si
Downloads

Spain

Member

Name
Eva A. Segovia
Affiliation
Agencia Espanola de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes, Edificio 8, C/ Campezo, 1, 28022 Madrid, SPAIN
Tel.
+34 91 822 57 50
Fax.
+34 91 822 53 36
Email
easegovia@aemps.es
Downloads

Alternate

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
Tel.
+34 91 8225330
Fax.
+34 91 8225336
Email
prayon@aemps.es
Downloads

Sweden

Member

Name
Ulla Wändel Liminga
Affiliation
Läkemedelsverket
Address
Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
Tel.
+46 18 174600
Fax.
+46 18 548566
Email
HPHARMACOVIGILANCE@lakemedelsverket.se
Downloads

Alternate

Name
Annika Folin
Affiliation
Läkemedelsverket
Address
Box 26, 751 03 Uppsala, SWEDEN
Tel.
+46 1 8174600
Fax.
+4618548566
Email
HPHARMACOVIGILANCE@lakemedelsverket.se
Downloads

Independent scientific experts nominated by the European Commission

Name
Birgitta Grundmark
Affiliation
Uppsala Monitoring Centre
Address
Bredgrand 7, Uppsala, SWEDEN
Tel.
+46 18 656093
Email
birgitta.grundmark@who-umc.org
Downloads
Name
Antoine Pariente
Affiliation
Université de Bordeaux
Address
Bâtiment 1A Zone nord, Site Carreire, BP36, 33076 Bordeaux, FRANCE
Tel.
+33 55 7571560
Fax.
+33 55 7574671
Email
antoine.pariente@u-bordeaux.fr
Downloads
Name
Stefan Weiler
Affiliation
University of Zurich
Address
Freiestrasse 16, 8032 Zurich, SWITZERLAND
Email
Stefan.Weiler@toxinfo.ch
Downloads
Name
Daniel Morales
Affiliation
University of Dundee / University of Southern Denmark
Address
School of Medicine, Quality, Safety and Informatics Research Group, Mackenzie Building, Kirsty Semple Way, Dundee, DD2 4BF, UNITED KINGDOM
Tel.
+44 1 38238475
Email
d.r.z.morales@dundee.ac.uk
Downloads
Name
Hedvig Marie Egeland Nordeng
Affiliation
University of Oslo
Address
P.O. Box 1068, Blindern, N-0316 Oslo, NORWAY
Tel.
+47 22 856604
Email
h.m.e.nordeng@farmasi.uio.no
Downloads
Name
Milou-Daniel Drici
Affiliation
Laboratoire de Pharmacologie-Bât. J4
Address
Hôpital Pasteur 1, 30 Avenue de la Voie Romaine CS 51069, 06001 Nice cedex 1, FRANCE
Tel.
+33 492 038502
Fax.
+33 492 037791
Email
drici.md@chu-nice.fr
Downloads

Members representing patients' organisations nominated by the European Commission

Member

Name
Cathalijne van Doorne
Affiliation
European Federation of Neurogical Associations (EFNA)
Address
Fondation Universitaire, 11 Rue d'Egmont, B-1000 Brussels, BELGIUM
Email
cathalijne.van.doorne@telenet.be
Downloads

Alternate

Name
Virginie Hivert
Affiliation
EURORDIS - Rare Diseases Europe
Address
Plateforme Maladies Rares, EURORDIS/PMR, 96 Rue Didot, 75014 Paris, FRANCE
Tel.
+33 1 56535219
Email
virginie.hivert@eurordis.org
Downloads

Members representing healthcare professionals nominated by the European Commission

Member

Name
Raymond Anderson
Affiliation
Pharmaceutical Group of the European Union (PGEU)
Address
Rue du Luxembourg 19-21, 1000 Bruxelles, BELGIUM
Tel.
+44 2838 330266
Fax.
+32 2 2380819
Email
ray@andersonspharmacy.co.uk
Downloads

Alternate

Name
Roberto Frontini
Affiliation
European Association of Hospital Pharmacists
Address
Rue Abbé Cuypers, 3, 10410 Brussels, BELGIUM
Tel.
+49 341 9718901
Fax.
+32 2 7347910
Email
frontini@gmx.de
Downloads