Expert Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products

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The Joint Committee for Medicinal Products for Veterinary Use/Committee for Medicinal Products for Human Use Ad-hoc Expert Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products (JEG 3Rs) provides advice and recommendations to the Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) on all matters relating to the use of animals and the application of the '3 R' principles (replacement, reduction and refinement) in the testing of medicines for regulatory purposes.

The Agency has also published its position on the application of the 3Rs in the testing of medicines, together with recommendations for marketing-authorisation holders on their need to comply with 3R methods in the European Pharmacopoeia:

Mandate, rules of procedure and work programme

Other JEG-3Rs publications

Composition

The JEG 3Rs consists of a core group of one or two European experts from each of the existing CVMP and CHMP Working Parties for which animal testing is relevant:

The core group also contains one member of the CVMP.

In addition to its core group, the Expert Group consists of a few experts with relevant experience.

Members

Below (in alphabetical order of surname) are the current members of the JEG 3Rs.  The members' declarations of interests are available in the European expert list.

CVMP Chair

Name
Anja Holm
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44 889259
Fax.
+45 44 889376
Email
anh@dkma.dk
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CVMP Vice-Chair

Name
David Murphy
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
david.murphy@hpra.ie
Downloads

Austria

Representative

Name
Barbara Zemann
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, AUSTRIA
Tel.
+43 50 55536824
Fax.
+43 50 55536809
Email
Barbara.Zemann@ages.at
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Alternates

Name
Ulrike Heissenberger
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, AUSTRIA
Tel.
+43 50 555 365 74
Fax.
+43 50 555 365 89
Email
ulrike.heissenberger@ages.at
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Belgium

Representative

Name
Bruno Urbain
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 5284130
Fax.
+32 2 5284136
Email
bruno.urbain@afmps.be
Downloads

Alternates

Name
Frédéric Klein
Title
Scientific evaluator - DG Pre
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 5284320
Email
Frederic.Klein@afmps.be
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Bulgaria

Representative

Name
Emil Kozhuharov
Affiliation
Българска агенция по безопасност на храните - Bulgarian Food Safety Agency
Address
Directorate for control of veterinary medicinal products, Shose Bankya 7 , 1331 Sofia, BULGARIA
Tel.
+359 2 4250636
Fax.
+359 2 9251435
Email
e_kozhuharov@itp.bg
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Alternates

Name
Svetoslav Valentinov Branchev
Affiliation
Българска агенция по безопасност на храните - Bulgarian Food Safety Agency
Address
Pencho Slaveykov Blvd 15, 1606 Sofia, BULGARIA
Tel.
+359 2 4250637
Fax.
+359 2 9251435
Email
s_branchev@itp.bg
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Croatia

Representative

Name
Ljiljana Markus Cizelj
Title
Head of Service for VMP, feed and animal by-products
Affiliation
Ministarstvo Poljoprivrede
Address
Uprava veterinarstva, Planinska ulica 2a, 10000 Zagreb, CROATIA
Tel.
+385 1 6443553
Fax.
+385 1 6443899
Email
ljiljana.cizelj@mps.hr
Downloads

Alternates

Name
Frane Božić
Title
Full professor
Affiliation
Faculty of Veterinary Medicine, University of Zagreb
Address
Ul. Heinzelova 55, HR-10000 Zagreb, CROATIA
Tel.
+385 1 2390163
Fax.
+385 1 2441390
Email
bozic@vef.hr
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Cyprus

Representative

Name
Alia Michaelidou-Patsia
Affiliation
ΥΠΟΥΡΓΕΙΟ ΓΕΩΡΓΙΑΣ, ΑΓΡΟΤΙΚΗΣ ΑΝΑΠΤΥΞΗΣ ΚΑΙ ΦΥΣΙΚΩΝ ΠΟΡΩΝ
Address
Athalassa, 1417 Nicosia, CYPRUS
Tel.
+357 22 805120
Fax.
+357 22 805122
Email
almichaelides@vs.moa.gov.cy
Downloads

Alternates

Awaiting Nomination.

Czech Republic

Representative

Name
Jiří Bureš
Affiliation
Ústav pro státní kontrolu veterinárních biopreparátů a léčiv
Address
Hudcova 56a, 621 00 Brno - Medlánky, CZECH REPUBLIC
Tel.
+420 541 518275
Fax.
+420 541 210026
Email
bures@uskvbl.cz
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Alternates

Name
Leona Nepejchalová
Affiliation
Ústav pro státní kontrolu veterinárních biopreparátů a léčiv
Address
Hudcova 56a, 621 00 Brno - Medlánky, CZECH REPUBLIC
Tel.
+420 541 518285
Fax.
+420 541 212607
Email
nepejchalova@uskvbl.cz
Downloads

Denmark

Representative

Name
Ellen-Margrethe Vestergaard
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 44 889264
Fax.
+45 44 889 599
Email
emv@dkma.dk
Downloads

Alternates

Name
Merete Blixenkrone-Møller
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 4112 9031
Fax.
+45 4488 9599
Email
mbkm@dkma.dk
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Estonia

Representative

Name
Toomas Tiirats
Title
Head of Department, Lecturer
Affiliation
Eesti Maaülikool
Address
Kreutzwaldi 62, 51014 Tartu, ESTONIA
Tel.
+372 73 13706
Email
Toomas.Tiirats@emu.ee
Downloads

Alternates

Awaiting Nomination.

Finland

Representative

Name
Martti Nevalainen
Title
Veterinary Officer
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O. Box 55, Mannerheimintie 103b, FI-00301 Helsinki, FINLAND
Tel.
+358 29522 3411
Email
martti.nevalainen@fimea.fi
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Alternates

Name
Kristina Lehmann
Title
Veterinary Officer
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O.Box 55, Mannerheiminitie 103b, 00034 - Fimea Helsinki, FINLAND
Tel.
+358 29522 3376
Fax.
+358 29522 3015
Email
kristina.lehmann@fimea.fi
Downloads

France

Representative

Name
Jean-Claude Rouby
Affiliation
Agence Nationale du Médicament Vétérinaire - Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail
Address
8 rue Claude Bourgelat, Parc d'Activités de la Grande Marche, CS 70611, Javené, 35306 Fougères Cedex, FRANCE
Tel.
+33 2 99 947841
Fax.
+33 2 99947899
Email
jean-claude.rouby@anses.fr
Downloads

Alternates

Name
Sylvie Louet
Affiliation
Agence Nationale du Médicament Vétérinaire - Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail
Address
8 rue Claude Bourgelat, Parc d'Activités de la Grande Marche, CS 70611, Javené, 35306 Fougères Cedex, FRANCE
Tel.
+33 2 99947878
Email
sylvie.louet@anses.fr
Downloads

Germany

Representative

Name
Cornelia Ibrahim
Affiliation
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Address
Mauerstraße 39-42, 10117 Berlin, GERMANY
Tel.
+49 30 184457400
Fax.
+49 30 1844430409
Email
cornelia.ibrahim@bvl.bund.de
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Alternates

Name
Esther Werner
Affiliation
Paul-Ehrlich-Institut
Address
Paul-Ehrlich-Str. 51-59, D-63225 Langen, GERMANY
Tel.
+49 6103 77 7401
Fax.
+49 6103 77 1254
Email
esther.werner@pei.de
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Greece

Representative

Name
Ioannis Malemis
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
Tel.
+30 213 2040277
Fax.
+30 210 653 7591
Email
malemisj@eof.gr
Downloads

Alternates

Name
Angeliki Tsigouri
Affiliation
National Organization for Medicines
Address
284 Mesogeion Avenue, Holargos, 15562 Athens, GREECE
Tel.
+30 213 2040342
Fax.
+30 210 6537591
Email
atsigouri@eof.gr
Downloads

Hungary

Representative

Name
Gábor Kulcsár
Affiliation
Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága
Address
Szállás u. 8, 1107 Budapest, HUNGARY
Tel.
+36 1 4330330-184
Fax.
+36 1 2622839
Email
kulcsarg@nebih.gov.hu
Downloads

Alternates

Name
Tibor Soós
Title
Director
Affiliation
Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága
Address
Szállás utca 8, 1107 Budapest, HUNGARY
Tel.
+36 1 2629579
Fax.
+36 1 2622839
Email
soost@nebih.gov.hu
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Iceland

Representative

Name
Johann M. Lenhardsson
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, ICELAND
Tel.
+354 5 202141
Fax.
+354 5 612170
Email
johann.m.lenhardsson@lyfjastofnun.is
Downloads

Alternates

Awaiting Nomination.

Ireland

Representative

Name
David Murphy
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
david.murphy@hpra.ie
Downloads

Alternates

Name
Jeremiah Gabriel Beechinor
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, IRELAND
Tel.
+353 1 6343467
Fax.
+353 1 6768490
Email
jgb@hpra.ie
Downloads

Italy

Representative

Name
Maria Tollis
Affiliation
Istituto Superiore di Sanità
Address
Viale Regina Elena, 299, 00161, Roma, ITALY
Tel.
+39 06 49902673
Fax.
+39 06 49387099
Email
m.tollis@iss.it
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Alternates

Name
Virgilio Donini
Affiliation
Ministero della Salute
Address
Via Giorgio Ribotta 5, 00144, Roma, ITALY
Tel.
+39 06 59946590
Fax.
+39 06 59946949
Email
v.donini@sanita.it
Downloads

Latvia

Representative

Name
Zanda Auce
Title
Head of Division
Affiliation
Pārtikas un veterinārais dienests
Address
Peldu iela 30, LV-1050 Rīga, LATVIA
Tel.
+371 6708 44618
Fax.
+371 670 95270
Email
zanda.auce@pvd.gov.lv
Downloads

Alternates

Name
Arvils Jakovskis
Affiliation
Pārtikas un veterinārais dienests
Address
Peldu iela 30, LV-1050 Riga, LATVIA
Tel.
+371 6708 4618
Fax.
+371 6709 5270
Email
arvils.jakovskis@pvd.gov.lv
Downloads

Lithuania

Representative

Name
Petras Mačiulskis
Title
Director
Affiliation
Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas
Address
Risk Assessment Department, J. Naujalio g. 21b, LT-48332 Kaunas-26, LITHUANIA
Tel.
+370 37 267598
Fax.
+370 37 406820
Email
pmaciulskis@vet.lt
Downloads

Alternates

Name
Sigitas Siriukaitis
Affiliation
Valstybinė maisto ir veterinarijos tarnyba
Address
Siesiku str. 19, LT-07170 Vilnius, LITHUANIA
Tel.
+370 5 2491617
Fax.
+370 5 2404362
Email
ssiriukaitis@vet.lt
Downloads

Luxembourg

Representative

Name
Marc Schmit
Title
Pharmacist
Affiliation
Ministère de la Santé
Address
Villa Louvigny - 1er étage, Allée Marconi, 2120 Luxembourg, LUXEMBOURG
Tel.
+352 247 85595
Fax.
+352 247 95615
Email
marc.schmit@ms.etat.lu
Downloads

Alternates

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

Malta

Representative

Name
Stephen Spiteri
Title
Principal pharmacist
Affiliation
Ministry for Resources and Rural Affairs
Address
Agriculture and Fisheries Regulation Department, Veterinary Medicines and Animal Nutrition Section, Abattoir Square, Albert Town, MRS 1123 Marsa, MALTA
Tel.
+356 22 925375
Fax.
+356 2 5905182
Email
stephen.spiteri@gov.mt
Downloads

Alternates

Awaiting Nomination.

Netherlands

Representative

Name
Gerrit Johan Schefferlie
Affiliation
College ter Beoordeling van Geneesmiddelen Bureau Diergeneesmiddelen
Address
P.O. Box 8275, 3503 RG Utrecht, NETHERLANDS
Tel.
+31 88 224 8235
Fax.
+31 88 224 8001
Email
gj.schefferlie@cbg-meb.nl
Downloads

Alternates

Name
Peter Hekman
Affiliation
College ter Beoordeling van Geneesmiddelen Bureau Diergeneesmiddelen
Address
P.O. Box 8275, 3503 RG Utrecht, NETHERLANDS
Tel.
+31 88 224 8099
Fax.
+31 88 224 8001
Email
p.hekman@cbg-meb.nl
Downloads

Norway

Representative

Name
Hanne Bergendahl
Affiliation
Statens legemiddelverk
Address
Postbox 63, Kalbakken, N-0901 Oslo, NORWAY
Tel.
+47 22 897759
Fax.
+47 22 897799
Email
hanne.bergendahl@legemiddelverket.no
Downloads

Alternates

Name
Tonje Høy
Affiliation
Statens legemiddelverk
Address
Postbox 63, Kalbakken, N-0901 Oslo, NORWAY
Tel.
+47 22 897765
Fax.
+47 22 897799
Email
tonje.hoy@legemiddelverket.no
Downloads

Poland

Representative

Name
Anna Wachnik-Święcicka
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Al. Jerozolimskie 181C, 02-222 Warszawa, POLAND
Tel.
+48 22 4920965
Fax.
+48 22 4921449
Email
anna.wachnik@urpl.gov.pl
Downloads

Alternates

Name
Ewa Augustynowicz
Affiliation
Narodowy Instytut Zdrowia Publicznego - Państwowy Zakład Higieny
Address
ul. Chocimska 24, 00-791 Warsaw, POLAND
Tel.
+48 22 542 1214
Fax.
+48 22 542 1311
Email
eaugustynowicz@pzh.gov.pl
Downloads

Portugal

Representative

Name
João Pedro Duarte Da Silva
Affiliation
Direcção-Geral de Alimentacao e Veterinaria
Address
Campo Grande no.50 , 1700-093 Lisboa, PORTUGAL
Tel.
+35 12 13 239 717
Fax.
+35 12 13 239 565
Email
joao.silva@dgav.pt
Downloads

Alternates

Name
Maria Azevedo Mendes
Affiliation
Direcção-Geral de Alimentacao e Veterinaria
Address
Campo Grande no.50 , 1700-093 Lisboa, PORTUGAL
Tel.
+351 21 7808237
Fax.
+351 21 3239565
Email
maria.mendes@dgav.pt
Downloads

Romania

Representative

Name
Lollita Sanda Camelia Taban
Title
Head of Laboratory
Affiliation
Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar
Address
39 Dudului Street, Sector 6, 060603 Bucharest, ROMANIA
Tel.
+40 21 220 2112
Fax.
+40 21 2213171
Email
lollita.taban@icbmv.ro
Downloads

Alternates

Name
Simona Sturzu
Affiliation
Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar
Address
39 Dudului Street, Sector 6, 060603 Bucharest, ROMANIA
Tel.
+40 21 2202112
Fax.
+40 21 2213171
Email
sturzu.simona@icbmv.ro
Downloads

Slovakia

Representative

Name
Judita Hederová
Affiliation
Ústav štátnej kontroly veterinárnych biopreparátov a liečiv
Address
Biovetská 34, 949 01 Nitra, SLOVAKIA
Tel.
+421 37 6933517
Fax.
+421 37 6517915
Email
hederova@uskvbl.sk
Downloads

Alternates

Name
Eva Chobotová
Affiliation
Ústav štátnej kontroly veterinárnych biopreparátov a liečiv
Address
Biovetská 34, 949 01 Nitra, SLOVAKIA
Tel.
+421 376 933523
Fax.
+421 376 517915
Email
chobotova@uskvbl.sk
Downloads

Slovenia

Representative

Name
Stane Srčič
Affiliation
Univerza v Ljubljani
Address
Askerceva 7, 1000 Ljubljana, SLOVENIA
Tel.
+386 1 4769500
Fax.
+386 1 4258031
Email
stane.srcic@ffa.uni-lj.si
Downloads

Alternates

Name
Katarina Straus
Title
Acting Director of Agency
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
katarina.straus@jazmp.si
Downloads

Spain

Representative

Name
Cristina Muñoz Madero
Title
Senior Assessor
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, SPAIN
Tel.
+34 91 8225432
Fax.
+34 91 8225443
Email
cmunoz@aemps.es
Downloads

Alternates

Name
Consuelo Rubio Montejano
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, SPAIN
Tel.
+34 91 8225403
Fax.
+34 91 8225443
Email
crubio@aemps.es
Downloads

Sweden

Representative

Name
Eva Lander Persson
Affiliation
Läkemedelsverket
Address
Box 26, 751 03 Uppsala, SWEDEN
Tel.
+46 18 174849
Email
eva.persson@mpa.se
Downloads

Alternates

Name
Frida Hasslung Wikström
Affiliation
Läkemedelsverket
Address
Box 26, 751 03 Uppsala, SWEDEN
Tel.
+46 18167776
Fax.
+46 18548566
Email
frida.wikstrom@mpa.se
Downloads

United Kingdom

Representative

Name
Helen Jukes
Affiliation
Veterinary Medicines Directorate
Address
Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS, UNITED KINGDOM
Tel.
+44 1932 338453
Fax.
+44 1932 336618
Email
h.jukes@vmd.defra.gsi.gov.uk
Downloads

Alternates

Name
Noemi Garcia del Blanco
Title
Veterinary Research Officer
Affiliation
Veterinary Medicines Directorate
Address
Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS, UNITED KINGDOM
Tel.
+44 1932 338370
Email
n.blanco@vmd.defra.gsi.gov.uk
Downloads

Co-opted members (with indication of their specific area of competence)

Antimicrobials and antimicrobial resistance

Name
Keith Baptiste
Title
Veterinary assessor
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, DENMARK
Tel.
+45 448 89732
Fax.
+45 44889599
Email
keb@dkma.dk
Downloads

Clinical veterinary practice

Name
Rory Breathnach
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
IE-V.CVE@IE-V.EUDRA.ORG
Downloads

Residue metabolism and pharmacokinetics

Name
Christian Friis
Title
Professor
Affiliation
University of Copenhagen
Address
Faculty of Life Sciences, Ridebanevej 9, 1870 Frederiksberg C, DENMARK
Tel.
+45 35 333161
Fax.
+45 35 353514
Email
cfr@sund.ku.dk
Downloads

Quality

Name
Wilhelm Schlumbohm
Affiliation
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Address
Mauerstraße 39-42, 10117 Berlin, GERMANY
Tel.
+49 30 18 445 7223
Fax.
+49 30 18 445 7098
Email
wilhelm.schlumbohm@bvl.bund.de
Downloads

Environmental risk assessment

Name
Jason Weeks
Address
10 Bedford Way, Sawtry, Huntingdon, Cambridgeshire, PE28 5QL, UNITED KINGDOM
Tel.
+44 7885 763768
Email
jasonweeks@btinternet.com
Downloads

Observers