PRAC members

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This page lists the current members and alternates of the Pharmacovigilance Risk Assessment Committee (PRAC). It lists each person's:

  • contact details;
  • curriculum vitae;
  • public declaration of interests and confidentiality undertaking.

For more information, see handling conflicts of interests.

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Members nominated by the Member States

Independent scientific experts nominated by the European Commission

Representative of healthcare professionals nominated by the European Commission

Representatives of patients organisations nominated by the European Commission

Chair

Name
June Munro Raine
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UNITED KINGDOM
Tel.
+44 20 30806400
Fax.
+44 20 87543960
Email
june.raine@mhra.gsi.gov.uk
Downloads

Vice-chair

Name
Almath Spooner
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
almath.spooner@hpra.ie
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
Marianne Lunzer
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, AUSTRIA
Tel.
+43 50555 36251
Fax.
+43 50555 36207
Email
marianne.lunzer@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
Veerle Verlinden
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 2 5284000
Fax.
+32 2 5248001
Email
veerle.verlinden@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
Yuliyan 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
Marina Dimov Di Giusti
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
Tel.
+385 1 4884100
Fax.
+385 1 4884110
Email
marina.dimov@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
Nectaroula Cooper
Affiliation
Ministry of Health
Address
Pharmaceutical Services, 1475 Nicosia, CYPRUS
Tel.
+357 22 608679
Fax.
+357 22 608649
Email
ncooper@phs.moh.gov.cy
Downloads

Alternate

Awaiting Nomination.

Czech Republic

Member

Name
Jana Mladá
Affiliation
Státní ústav pro kontrolu léčiv
Address
Šrobárova 48, 100 41 Prague, CZECH REPUBLIC
Tel.
+420 272 185729
Fax.
+420 272 185222
Email
jana.mlada@sukl.cz
Downloads

Alternate

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

Denmark

Member

Name
Doris Stenver
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44 889247
Fax.
+45 44 889599
Email
dis@dkma.dk
Downloads

Alternate

Name
Torbjorn Callreus
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44 889140
Fax.
+45 44 889599
Email
TCA@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

Awaiting Nomination.

Alternate

Name
Claire Ferard
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 1 55 87 3665
Fax.
+33 1 55 87 3532
Email
claire.ferard@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
Valerie Strassmann
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
Tel.
+49 228 2073538
Fax.
+49 228 2073515
Email
valerie.strassmann@bfarm.de
Downloads

Greece

Member

Name
Leonidas Klironomos
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
Tel.
+30 213 2040337
Fax.
+30 210 6549585
Email
leokli@eof.gr
Downloads

Alternate

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

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 Kristín Steingrímsdóttir
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
Tel.
+354 520 21 00
Fax.
+354 561 21 70
Email
gudrun.kristin.steingrimsdottir@lyfjastofnun.is
Downloads

Alternate

Name
Hrefna Gudmundsdottir
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
Tel.
+354 520 2100
Email
hrefna.gudmundsdottir@ima.is
Downloads

Ireland

Member

Name
Almath Spooner
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
almath.spooner@hpra.ie
Downloads

Alternate

Name
Ruchika Sharma
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
ruchika.sharma@hpra.ie
Downloads

Italy

Member

Name
Carmela Macchiarulo
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, ITALY
Tel.
+39 06 59784385
Fax.
+39 06 59784142
Email
c.macchiarulo@aifa.gov.it
Downloads

Alternate

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

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 8438
Fax.
+371 670 78428
Email
Zane.Stade@zva.gov.lv
Downloads

Lithuania

Member

Name
Jolanta Gulbinovic
Affiliation
Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos
Address
Žirmūnų str.139A, 09120 Vilnius, LITHUANIA
Tel.
+370 5 2124059
Fax.
+370 5 2639265
Email
jolantagulbinovic@vvkt.lt
Downloads

Alternate

Name
Simona Kudeliene
Affiliation
Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos
Address
Žirmūnų str.139A, 09120 Vilnius, LITHUANIA
Tel.
+370 5 2124059
Fax.
+370 5 2639265
Email
SimonaKudeliene@vvkt.lt
Downloads

Luxembourg

Member

Name
Marcel Bruch
Affiliation
Ministère de la Santé
Address
Villa Louvigny - 1er étage, Allée Marconi, 2120 Luxembourg, LUXEMBOURG
Tel.
+352 2 478 5591
Fax.
+352 2 479 5592
Email
Marcel.Bruch@ms.etat.lu
Downloads

Alternate

Name
Nadine Petitpain
Affiliation
Centre Regional de Pharmacovigilance de Lorraine
Address
29 av de Mal de Tassigny, Nancy, FRANCE
Tel.
+33 3 83852761
Email
n.petitpain@chu-nancy.fr
Downloads

Malta

Member

Name
Amy Tanti
Affiliation
Awtorità dwar il-Mediċini
Address
203, Level 3, rue D'Argens, GZR 1368 Gzira, MALTA
Tel.
+356 23 439178
Fax.
+356 23 439161
Email
amy.tanti@gov.mt
Downloads

Alternate

Name
John Joseph Borg
Affiliation
Awtorità dwar il-Mediċini
Address
203, Level 3, rue D'Argens, GZR 1368 Gzira, MALTA
Tel.
+356 23 439129
Fax.
+356 23 439158
Email
john-joseph.borg@gov.mt
Downloads

Netherlands

Member

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

Alternate

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

Norway

Member

Name
Ingebjørg Buajordet
Affiliation
Statens legemiddelverk
Address
Postbox 63, Kalbakken, N-0901 Oslo, NORWAY
Tel.
+47 22 897581
Fax.
+47 22 897799
Email
ingebjorg.buajordet@noma.no
Downloads

Alternate

Name
Kristin Thorseng Kvande
Affiliation
Statens legemiddelverk
Address
Postbox 63, Kalbakken, N-0901 Oslo, NORWAY
Tel.
+47 22 897594
Fax.
+47 22 89 7799
Email
kristin.kvande@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@interia.pl
Downloads

Alternate

Name
Magdalena Budny
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
Tel.
+48 22 4921350
Fax.
+48 22 4921109
Email
magdalena.budny@urpl.gov.pl
Downloads

Portugal

Member

Name
Margarida Guimarães
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 7142
Email
margarida.guimaraes@infarmed.pt
Downloads

Alternate

Name
Leonor Chambel
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 985264
Fax.
+351 217 987397
Email
leonor.chambel@infarmed.pt
Downloads

Romania

Member

Name
Roxana Stefania Stroe
Affiliation
Agentia Natională a Medicamentului şi a Dispozitivelor Medicale
Address
Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, ROMANIA
Tel.
+40 21 3171100
Fax.
+40 21 3163497
Email
roxana.stroe@anm.ro
Downloads

Alternate

Name
Nicolae Fotin
Affiliation
Agentia Natională a Medicamentului şi a Dispozitivelor Medicale
Address
Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, ROMANIA
Tel.
+40 21 3161079
Fax.
+40 21 3163497
Email
nicolae.fotin@anm.ro
Downloads

Slovakia

Member

Name
Tatiana Magalova
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
Tel.
+421 2 50701207
Fax.
+421 2 50701237
Email
tatiana.magalova@sukl.sk
Downloads

Alternate

Name
Miroslava Matíková
Affiliation
Štátny ústav pre kontrolu liečiv
Address
Kvetná 11, 825 08 Bratislava 26, SLOVAKIA
Tel.
+421 2 50701210
Fax.
+421 2 55564127
Email
miroslava.matikova@sukl.sk
Downloads

Slovenia

Member

Name
Milena Radoha-Bergoc
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
milena.bergoc@jazmp.si
Downloads

Alternate

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

Spain

Member

Name
Dolores Montero Corominas
Affiliation
Agencia Española 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
dmontero@aemps.es
Downloads

Alternate

Name
Miguel-Angel Macia
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes, Edificio 8, C/ Campezo, 1, 28022 Madrid, SPAIN
Tel.
+34 91 8225315
Fax.
+34 91 8225336
Email
mmacia@aemps.es
Downloads

Sweden

Member

Name
Ulla Wändel Liminga
Affiliation
Läkemedelsverket
Address
P.O. Box 26, SE-751 03 Uppsala, Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
Tel.
+46 18 174600
Fax.
+46 18 548566
Email
HPHARMACOVIGILANCE@mpa.se
Downloads

Alternate

Name
Qun-Ying Yue
Affiliation
Läkemedelsverket
Address
P.O. Box 26, SE-751 03 Uppsala, Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
Tel.
+46 18 174600
Fax.
+46 18 548566
Email
HPHARMACOVIGILANCE@mpa.se
Downloads

United Kingdom

Member

Name
Julie Williams
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UNITED KINGDOM
Tel.
+44 20 30806369
Email
julie.williams@mhra.gsi.gov.uk
Downloads

Alternate

Name
Rafe Suvarna
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UNITED KINGDOM
Tel.
+44 20 30807406
Email
Rafe.Suvarna@mhra.gsi.gov.uk
Downloads

Independent scientific experts nominated by the European Commission

Name
Thierry Trenque
Organisation
CHU Reims
Address
Avenue du General Koenig, 51092 Reims, FRANCE
Tel.
+33 3 26788419
Fax.
+33 3 26832379
Email
ttrenque@chu-reims.fr
Downloads
Name
Marie Louise (Marieke) De Bruin
Organisation
College ter Beoordeling van Geneesmiddelen
Address
P.O Box 8275, 3503 Utrecht RG , NETHERLANDS
Tel.
+31 88 224 8000
Fax.
+31 88 224 8001
Email
m.d.bruin@cbg-meb.nl
Downloads
Name
Stephen J. W. Evans
Organisation
London School of Hygiene and Tropical Medicine
Address
Keppel Street, London, WC1E 7HT, UNITED KINGDOM
Tel.
+44 20 79272960
Fax.
+44 20 74365389
Email
stephen.evans@lshtm.ac.uk
Downloads
Name
Brigitte Keller-Stanislawski
Organisation
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
Name
Herve Le Louet
Organisation
Hopital Henri Mondor
Address
51 Avenue du Mal de Lattre de Tassigny, 94010 Creteil Cedex, FRANCE
Tel.
+33 1 49814702
Fax.
+33 1 49814763
Email
herve.le-louet@hmn.aphp.fr
Downloads
Name
Lennart Waldenlind
Address
Kommendörsgatan 5, 4tr, 11448 Stockholm, SWEDEN
Tel.
+46 70 3190562
Email
Lennart.Waldenlind@outlook.com
Downloads

Representative of 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
Kirsten Myhr
Affiliation
Health Action International-Europe (HAI)
Address
Hovdeplassen 35, 3612 Kongsberg, NORWAY
Tel.
+47 416 38747
Email
myhr@online.no
Downloads

Representatives of patients organisations nominated by the European Commission

Member

Name
Marco Greco
Affiliation
European Federation of Crohn's & Ulcerative Colitis Associations
Address
EFCCA, c / o Avv. Marco Greco, Via Carducci 9, 20064, 20062 CASSANO D'ADDA (MI), ITALY
Tel.
+39 03 6361131
Fax.
+39 0363 564773
Email
marco.greco@efcca.org
Downloads

Alternate

Name
Albert van der Zeijden
Affiliation
International Alliance of Patients' Organizations (IAPO)
Address
49-51 East Road, London, N1 6AH, UNITED KINGDOM
Tel.
+31 30 271 89 51
Fax.
+31 30 2970111
Email
avanderz@xs4all.nl
Downloads