Mailing list for paediatric investigation plans

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This page shows the mailing list for paediatric-investigation-plan applications.

PDCO members require submission of applications by CD/DVD, even when they have been submitted by Eudralink or via the eSubmission Gateway or the eSubmission Web Client to EMA.

  • Send applications via Eudralink only to those members whose address reads “Eudralink applications only"
  • For Member States awaiting nomination, send applications directly to the appropriate National competent authority.

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Members nominated by the Member States

Members representing patients' organisations

Members representing healthcare professionals' organisations

Chair

Name
Dirk Mentzer
Affiliation
Paul-Ehrlich-Institut
Address
Paul-Ehrlich-Str. 51-59, D-63225 Langen, Germany
Tel.
+49 6103 771065
Fax.
+49 6103 771263
Email
Dirk.Mentzer@pei.de

Members nominated by Member States

Austria

Representative

Name
Karl-Heinz Huemer
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A-1200 Vienna, Austria
Tel.
+43 50 55536816
Email
karl-heinz.huemer@ages.at

Alternates

Name
Johanna Wernsperger
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, Austria
Tel.
+43 50555 36558
Fax.
+43 50555 36559
Email
basg-paediatric@ages.at

Belgium

Representative

Name
Koenraad Norga
Affiliation
Universitair Ziekenhuis Antwerpen
Address
Wilrijkstraat 10, 2650 Edegem, Belgium
Tel.
+32 3821 5944
Fax.
+32 3821 1194
Email
Koen.Norga@uza.be

Alternates

Name
Karen Van Malderen
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 2528 4384
Email
karen.vanmalderen@fagg-afmps.be

Bulgaria

Representative

Name
Dimitar Roussinov
Affiliation
Specialized hospital for active treatment of children's diseases professor Ivan Mitev
Address
11 Academician Ivan Geshov Blvd, 1606 Sofia, Bulgaria
Tel.
+359 2 8154322
Fax.
+359 2 8154250
Email
dimitar.roussinov@bda.bg

Alternates

Name
Vessela Boudinova
Affiliation
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Address
8, Damyan Gruev str., 1303 Sofia, Bulgaria
Tel.
+35 92 8903490
Fax.
+359 2 8903434
Email
vessela.boudinova@bda.bg

Croatia

Representative

Name
Adriana Andrić
Address
Eudralink applications only, CROATIA
Tel.
+385 1 4884332
Fax.
+385 1 4884110
Email
adriana.andric@halmed.hr

Alternates

Name
Suzana Mimica Matanovic
Address
Eudralink applications only, CROATIA
Tel.
+385 315 11108
Fax.
+385 315 12177
Email
mimica.suzana@kbo.hr

Cyprus

Representative

Name
Georgios Savva
Affiliation
Ministry of Health
Address
Pharmaceutical Services, 1475 Nicosia, Cyprus
Tel.
+357 22 608650
Fax.
+357 22 608649
Email
gsavva@phs.moh.gov.cy

Alternates

Name
Eirini Perikleous
Affiliation
Ministry of Health
Address
Pharmaceutical Services, 1475 Nicosia, Cyprus
Tel.
+357 2240 7138
Email
ipericleous@phs.moh.gov.cy

Czech Republic

Representative

Name
Jaroslav Sterba
Affiliation
University Hospital Brno
Address
Cernopolni str. 9, 625 00 Brno, Czech Republic
Tel.
+42 053 2234600
Fax.
+42 053 2234614
Email
jsterb@fnbrno.cz

Alternates

Name
Peter Szitanyi
Affiliation
First Faculty of Medicine and General Teaching Hospital
Address
Ke Karlovu 2 , 121 09 Prague, CZECH REPUBLIC
Tel.
+420 224 967734
Email
peter.szitanyi@vfn.cz

Denmark

Representative

Name
Marianne Orholm
Address
Eudralink applications only, DENMARK
Tel.
+45 353 71088
Email
mao@dkma.dk

Alternates

Name
Marta Granström
Address
Eudralink applications only, SWEDEN
Tel.
+46 8517 73564
Fax.
+46 830 8099
Email
marta.granstrom@ki.se

Estonia

Representative

Name
Irja Lutsar
Affiliation
Tartu Ülikool
Address
Ravila Str. 19, 51014 Tartu, Estonia
Tel.
+372 7 374 171
Fax.
+372 7 374 172
Email
irja.lutsar@ut.ee

Alternates

Name
Jana Lass
Affiliation
Ravimiamet
Address
1, Nooruse Street, 50411 Tartu, Estonia
Tel.
+372 7 318333
Fax.
+372 7 318302
Email
Jana.lass@kliinikum.ee

Finland

Representative

Name
Ann Marie Kaukonen
Title
Senior Researcher
Address
Fimea, Nauvontie 4, 00280 Helsinki, FINLAND
Tel.
+358 29522 3351
Email
AnnMarie.Kaukonen@fimea.fi

Alternates

Name
Maija Pihlajamaki
Address
Fimea, Nauvontie 4, 00280 Helsinki, FINLAND
Tel.
+358 29522 3424
Email
Maija.Pihlajamaki@fimea.fi

France

Representative

Name
Sylvie Benchetrit
Address
Eudralink applications only, FRANCE
Tel.
+33 155 873834
Email
sylvie.benchetrit@ansm.sante.fr

Alternates

Name
Dominique Ploin
Address
Eudralink applications only, FRANCE
Tel.
+33 427 856212
Email
dominique.plon@chu-lyon.fr

Germany

Representative

Name
Sabine Scherer
Affiliation
Bundesinstitut für Arzneimittel und Medizinprodukte
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, GERMANY
Tel.
+49 228 207 3189
Fax.
+49 228 207 3534
Email
paediatric@bfarm.de

Alternates

Name
Immanuel Barth
Affiliation
Paul-Ehrlich-Institut
Address
Paul-Ehrlich-Str. 51-59, D-63225 Langen, Germany
Tel.
+49 610 3771813
Fax.
+49 610 3771234
Email
pdco@pei.de

Greece

Representative

Name
Eleni Katsomiti
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, Greece
Tel.
30 21 32040418
Fax.
30 21 32040560
Email
l.katsomiti@eof.gr

Alternates

Name
Anastasia Mountaki
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, Greece
Tel.
+30 21 32040247
Fax.
+30 21 32040560
Email
amountaki@eof.gr

Hungary

Representative

Name
Agnes Gyurasics
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Zrínyi U. 3, 1051 Budapest, Hungary
Tel.
+36 1 8869302
Fax.
+36 1 8869462
Email
gyurasics.agnes@ogyei.gov.hu

Alternates

Name
Melinda Sobor
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Zrínyi U. 3, 1051 Budapest, Hungary
Tel.
+36 1 8869300
Fax.
+36 1 886 9460
Email
sobor.melinda@ogyei.gov.hu

ICELAND

Representative

Awaiting Nomination.

Alternates

Awaiting Nomination.

Ireland

Representative

Name
Brian Aylward
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, Ireland
Tel.
+353 1676 4971
Fax.
+353 1 6767836
Email
brian.aylward@hpra.ie

Alternates

Awaiting Nomination.

Italy

Representative

Name
Sara Galluzzo
Affiliation
Agenzia Italiana del Farmaco
Address
Via del Tritone, 181, 00187, Roma, Italy
Tel.
+39 06 59784188
Fax.
+39 06 59784054
Email
pdcocomm@aifa.gov.it

Alternates

Name
Alessandro Jenkner
Address
Eudralink applications only, ITALY
Tel.
+39 06 68592935
Email
pdcocomm@aifa.gov.it

Latvia

Representative

Name
Dina Apele-Freimane
Address
Zāļu valsts aģentūra, Jersikas iela 15, LV-1003 Riga, LATVIA
Tel.
+371 6 707 8415
Fax.
+371 6 707 8428
Email
Dina.Apele@zva.gov.lv

Alternates

Name
Kristine Supe
Affiliation
Zāļu valsts aģentūra
Address
Jersikas iela 15, LV-1003 Riga, Latvia
Tel.
+37 1 67078458
Fax.
+37 1 67078428
Email
kristine.supe@zva.gov.lv

Lithuania

Representative

Name
Sigita Burokiene
Affiliation
Vilnius University Hospital
Address
Santariskiu Street 7, 08406 Vilnius, LITHUANIA
Tel.
+370 5272 0202
Email
sigita.burokiene@vuvl.lt

Alternates

Name
Goda Vaitkeviciene
Affiliation
Vilnius University Hospital
Address
Santariskiu Street 7, 08406 Vilnius, LITHUANIA
Tel.
+370 5 2328703
Email
goda.vaitkeviciene@vuvl.lt

Luxembourg

Representative

Name
Carola de Beaufort
Affiliation
Centre Hospitalier de Luxembourg
Address
4, rue Barblé, 1210 Luxembourg, Luxembourg
Tel.
+352 44 113 133
Fax.
+352 458 762
Email
debeaufort.carine@chl.lu

Alternates

Name
Jacqueline Genoux-Hames
Affiliation
Ministère de la Santé
Address
Villa Louvigny - 1er étage, Allée Marconi, 2120 Luxembourg, Luxembourg
Tel.
+352 247 85593
Fax.
+352 247 95593
Email
jacqueline.genoux-hames@ms.etat.lu

Malta

Representative

Name
John Joseph Borg
Affiliation
Awtorità dwar il-Mediċini
Address
Sir Temi Zammit Buildings, SGN 3000 San Gwann, MALTA
Tel.
+356 23 439129
Fax.
+356 23 439158
Email
john-joseph.borg@gov.mt

Alternates

Name
Herbert Lenicker
Affiliation
Awtorità dwar il-Mediċini
Address
Sir Temi Zammit Buildings, SGN 3000 San Gwann, MALTA
Tel.
+356 2 343 9155
Fax.
+356 2 343 9161
Email
herbert.m.lenicker@gov.mt

Netherlands

Representative

Name
Maaike van Dartel
Affiliation
College ter Beoordeling van Geneesmiddelen
Address
P.O Box 8275, 3503 Utrecht RG , Netherlands
Tel.
+31 88 2248000
Email
paediatrics@cbg-meb.nl

Alternates

Awaiting Nomination.

Norway

Representative

Name
Siri Wang
Affiliation
Statens legemiddelverk
Address
Strømsveien 96, 0663 Oslo, Norway
Tel.
+47 22 89 77 00
Fax.
+47 22 89 77 99
Email
siri.wang@legemiddelverket.no

Alternates

Name
Ine Skottheim Rusten
Affiliation
Statens legemiddelverk
Address
Strømsveien 96, 0663 Oslo, Norway
Tel.
+47 2289 7926
Fax.
+47 2289 7799
Email
ine.skottheim.rusten@noma.no

Poland

Representative

Name
Marek Migdal
Affiliation
Instytut Pomnik Centrum Zdrowia Dziecka
Address
Al. Dzieci Polskich 20, 04-730 Warsaw, Poland
Tel.
+48 22 8151335
Fax.
+48 22 8151327
Email
m.migdal@czd.pl

Alternates

Name
Jolanta Witkowska-Ożogowska
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, Poland
Tel.
+48 22 49 21 423
Fax.
+48 22 49 21 109
Email
jolanta.witkowska@urpl.gov.pl

Portugal

Representative

Name
Helena Fonseca
Title
MD, MPH
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 21 7597730
Email
helena.fonseca@infarmed.pt

Alternates

Name
Hugo Tavares
Address
Eudralink applications only, PORTUGAL
Tel.
+351 93640 7881
Email
hugo.tavares@infarmed.pt

Romania

Representative

Name
Dana Gabriela Marin
Affiliation
Agentia Natională a Medicamentului şi a Dispozitivelor Medicale
Address
Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, Romania
Tel.
+40 21 317 11 02
Fax.
+40 21 316 34 97
Email
dana.marin@anm.ro

Alternates

Name
Nela Vilceanu
Affiliation
Agentia Natională a Medicamentului şi a Dispozitivelor Medicale
Address
Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, Romania
Tel.
+40 2 13161079
Fax.
+40 2 13163497
Email
nela.vilceanu@anm.ro

SLOVAKIA

Representative

Awaiting Nomination.

Alternates

Awaiting Nomination.

Slovenia

Representative

Name
Stefan Grosek
Affiliation
University Medical Center Ljubljana
Address
Bohoriceva 20, 1525 Ljubljana, Slovenia
Tel.
+386 1 5224829
Fax.
+386 1 5221109
Email
stefan.grosek@kclj.si

Alternates

Awaiting Nomination.

Spain

Representative

Name
Fernando de Andrés Trelles
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, Spain
Tel.
+34 91 8225129
Fax.
+34 91 8225144
Email
copdspain@aemps.es

Alternates

Name
Maria Jesús Fernández Cortizo
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, Spain
Tel.
+34 91 8225165
Fax.
+34 91 8225161
Email
copdspain@aemps.es

Sweden

Representative

Name
Ninna Gullberg
Address
Eudralink applications only, SWEDEN
Tel.
+46 18 178268
Fax.
+46 18 548566
Email
ninna.gullberg@mpa.se

Alternates

Name
Eva Agurell
Address
Eudralink applications only, SWEDEN
Tel.
+46 18 174600
Fax.
+46 18 54 85 66
Email
pdco@mpa.se

United Kingdom

Representative

Name
Angeliki Siapkara
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
Eudralink applications only, UNITED KINGDOM
Tel.
+44 207 0806440
Email
ukpip@mhra.gov.uk

Alternates

Name
Martina Riegl
Address
Eudralink applications only, UNITED KINGDOM
Tel.
+44 20 30806440
Email
ukpip@mhra.gov.uk

Members representing patients' organisations

Representative

Name
Tsveta Schyns-Liharska
Address
EURORDIS, Eudralink applications only
Email
ts@enrah.net

Alternates

Awaiting Nomination.

Representative

Name
Günter Karl-Heinz Auerswald
Address
European Haemophilia Consortium, Eudralink applications only
Email
Guenter.Auerswald@ext.ema.europa.eu

Alternates

Name
Paola Baiardi
Address
Foundation Salvatore Maugeri IRCCS, Eudralink applications only
Email
paola.baiardi@fsm.it

Representative

Name
Michal Odermarsky
Address
European AIDS Treatment Group, Eudralink applications only, SWEDEN
Email
michal.odermarsky@med.lu.se

Alternates

Name
Milena Stevanovic
Address
European AIDS Treatment Group, Eudralink applications only, MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF
Email
MStevanovic@infektivnaklinika.mk

Members representing healthcare professionals' organisations

Representative

Name
Antje Neubert
Address
University Hospital Erlangen, Eudralink applications only
Email
antje.neubert@uk-erlangen.de

Alternates

Name
Paolo Paolucci
Address
University of Modena and Reggio Emilia, Eudralink applications only
Email
paolo.paolucci@unimore.it

Representative

Name
Johannes Taminiau
Address
Universitair Ziekenhuis Antwerpen, Eudralink applications only
Email
J.A.Taminiau@amc.uva.nl

Alternates

Name
Doina Plesca
Address
University of Medicine and Pharmacy "Carol Davila", Eudralink applications only
Email
doinaplesca@yahoo.com

Representative

Name
Riccardo Riccardi
Affiliation
Universita Cattolica del Sacro Cuore
Address
Eudralink applications only, ITALY
Email
riccardo.riccardi@unicatt.it

Alternates

Name
Jorrit Gerritsen
Affiliation
European Respiratory Society
Address
Eudralink applications only, NETHERLANDS
Email
gerritsenj02@umcg.nl

Page last updated: 27 May, 2017