L A50 Gremien MEA

Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
nationale Gremien / national committees and working groups
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
Dr. Reinhard Berger
AGES
Mitglied
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
Dr. Michael Behounek
AGES
Mitglied
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
Mag.a Sofie Regner
AGES
stv. Mitglied
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
Mag. Thomas Reichhart
AGES
Mitglied
Abgrenzungsbeirat
AGBR
G
§ 49a AMG
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Mitglied
Abgrenzungsbeirat gem. MPG (§5b)
MPG
G
MPG §5b
Dr. Reinhard Berger
AGES
Mitglied
Abgrenzungskommission
ABGRK AMG
G
§ 60 AMG
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
stv. Mitglied
Abgrenzungskommission
ABGRK AMG
G
§ 60 AMG
Mag.a Dr.in Astrid Obmann
AGES
Mitglied
Mag.a Roswitha Frieht
AGES
Mitglied
Arbovirus‐Bereitschaftsgruppe
Ausschuss "Rationaler Einsatz von Arzneimitteln"
des Arzneimittelbeirates
I
Health Technology Assessment
Austrian Medicines Enforcement Group – Member
Austrian Medicines Enforcement Group
of the Management Committee
Austrian Medicines Enforcement Group – Member
Austrian Medicines Enforcement Group
of the Management Committee
Austrian Medicines Enforcement Group – Member
Austrian Medicines Enforcement Group
of the Management Committee
HTA
F
§ 49 Abs. 8 Arzneimittelgesetz
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
AMEG
F
Beschluss BMG
Mag. Roman Macas
AGES
Mitglied
AMEG
F
Beschluss BMG
Dr. Andreas Hackl
AGES
Mitglied
AMEG
F
Beschluss BMG
Mag. Hannes Würkner
AGES
Mitglied
Billroth Haus ‐ Gesellschaft der Ärzte
I
AGES
Mitglied
Mag. Andreas Krassnigg
AGES
stv. Vorsitz
Blutkommission
BK
G
Codex‐Unterkommission B 33 und A 8 kosmetische
Mittel
UK Kosmetik
F
LMSVG BGBl. I Nr. 13/2006
Dr. Michael Behounek
AGES
Mitglied
Codex‐Unterkommission
Nahrungsergänzungsmittel
UK "NEM"
G
LMSVG BGBl. I Nr. 13/2006
Dr. Michael Behounek
AGES
Mitglied
Codex‐Unterkommission Tee und teeähnliche
Erzeugnisse
UK "B31"
F
LMSVG BGBl. I Nr. 13/2006
Mag.a Dr.in Astrid Obmann
AGES
Mitglied
div. Lehrbeauftragte
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Lehrbeauftragte
/r
div. Lehrbeauftragte
Mag.a Dr.in Astrid Obmann
AGES
Lehrbeauftragte
/r
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
European Neuropeptide Club
European Neuropeptide Club
ANA
I
EWS‐AT‐Beirat (Early Warning System, ÖBIG)
Early Warning System, ÖBIG
EWS, ÖBIG
F
BMG‐Auftrag / Council Decision 2005/387/JHA
Dr. Andreas Hackl
AGES
Mitglied
Expertengruppe Österreichisches Arzneibuch
ÖAB
F
AB‐Gesetz
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
Expertengruppe Österreichisches Arzneibuch
ÖAB
F
AB‐Gesetz
Mag. Roman Macas
AGES
stv. Vorsitz
G
MPG § 117
Dr. Reinhard Berger
AGES
Mitglied
Medizinproduktebeirat
Nationales Impfgremium
National Vaccination board
NIG
G
§ 8 Bundesministeriengesetz 1986
Mag.a Petra Falb
AGES
Mitglied
Nationales Impfgremium
National Vaccination board
NIG
G
§ 8 Bundesministeriengesetz 1986
Dr.in Barbara Tucek, MSc
AGES
Mitglied
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
Newsletter Redaktionsteam BMG
I
ÖNORM Fachnormungsausschuss FNA179
Medizinprodukte allgemein
FNA 179
G
Art.5 RL 93/42/EG basierend auf RL 98/34 EG,
implementiert in das MPG
Dr. Reinhard Berger
AGES
Mitglied
ÖNORM Fachnormungsausschuss in vitro
Diagnostik
FNA 179‐08
G
Art.5 RL 93/42/EG basierend auf RL 98/34 EG,
implementiert in das MPG
Dr. Reinhard Berger
AGES
Mitglied
Dr. Reinhard Berger
AGES
Mitglied
ÖNORM Fachnormungsausschuss Medizingeräte
FNA‐MG
G
Art.5 RL 93/42/EG basierend auf RL 98/34 EG,
implementiert in das MPG
Österr. Plattform für Gesundheitskompetenz
ÖPGK
F
Art. 15a Bundesverfassungsgesetz (BV‐G)
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Mitglied
österreichische Arzneibuchkommission
ÖAB Komm.
G
AB‐Gesetz
DI Thomas Lang
AGES
stv. Mitglied
österreichische Arzneibuchkommission
ÖAB Komm.
G
AB‐Gesetz
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
österreichische Arzneibuchkommission
ÖAB Komm.
G
AB‐Gesetz
Mag. Roman Macas
AGES
Mitglied
österreichische Arzneibuchkommission
ÖAB Komm.
G
AB‐Gesetz
Mag.a Dr.in Ingrid Werner
AGES
stv. Mitglied
Österreichische Gesellschaft für Arzneimittel in der
Psychiatrie
ÖAMSP
I
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
Österreichische Gesellschaft für Kinder‐ und
Jugendheilkunde
ÖGKJ
I
DDr. Karl‐Heinz Huemer
AGES
Mitglied
APHAR
I
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
F
Dr. Christoph Baumgärtel, MSc
AGES
Vorsitz
Österreichische Pharmakologische Gesellschaft
OTC Kommission für ELGA
L_MEA_SGB_00QM_A50_21
Dr.in Milena Stain
Verordnung BGBl. II Nr. 267/2006 über die Einrichtung
einer Blutkommission
Austrian Pharmacological Society
Gültig ab: 03.06.2016
Seite 1/10
Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
Rezeptpflichtkommission
G
§ 5 Rezeptpflichtgesetz
Dr. Christoph Baumgärtel, MSc
AGES
stv. Vorsitz
Rezeptpflichtkommission
G
§ 5 Rezeptpflichtgesetz
Mag.a Katrin Schlager, MSc
AGES
Mitglied
G
Suchtgift‐VO § 23 i
Mag. Markus Pongratz
AGES
Mitglied
F
§ 85 (1) Z 3 Gentechnikgesetz (GTG), BGBl. Nr. 510/1994
idgF
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
F
§ 49 Abs. 8 Arzneimittelgesetz
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
F
§ 49 Abs. 8 Arzneimittelgesetz
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Vorsitz
Wissenschaftlicher Beirat Pandemie
G
Pandemieplan, Seuchengesetz
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
Wissenschaftlicher Beirat Pandemie
G
Pandemieplan, Seuchengesetz
Mag.a Petra Falb
AGES
Mitglied
Wissenschaftlicher Beirat Pandemie
G
Pandemieplan, Seuchengesetz
Dr.in Barbara Tucek, MSc
AGES
Mitglied
Sachverständigenkommission zur regionalen
Koordination der Substitutionsbehandlung gem. §
23i SV
Wissenschaftlicher Ausschuss der
Scientific Board of genetic analysis and gene‐
Gentechnikkommission für Genanalyse und
therapy
Gentherapie am Menschen
Wissenschaftlicher Ausschuss des
Scientific Board
Arzneimittelbeirates
Wissenschaftlicher Ausschuss des
Arzneimittelbeirates
WAGG
Scientific Board
Gremien der Europäischen Kommission/ committees and working groups of the European Commission
EC Gremien Arzneimittel / medicines
Pharmaceutical Committee
Pharmaceutical Committee
G
75/320/EEC: Council Decision of 20 May 1975 setting up a
Mag. Thomas Reichhart
pharmaceutical committee
AGES
stv. Mitglied
Pharmaceutical Committee
Pharmaceutical Committee
G
75/320/EEC: Council Decision of 20 May 1975 setting up a
DI, Dr.in Christa Wirthumer‐Hoche
pharmaceutical committee
AGES
Mitglied
Pharmaceutical Committee
Pharmaceutical Committee
G
75/320/EEC: Council Decision of 20 May 1975 setting up a
Mag.a Martina Hofmann, LLM
pharmaceutical committee
AGES
stv. Mitglied
Verwaltungsrat der europäischen
Arzneimittelagentur
European Medicines Agency Management Board
EMA ManagemG
Regulation (EC) No 726/2004, Art 56 (1.g)
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Vorsitz
Arbeitsgruppe Hämovigilanz
SARE Working Group
SARE
F
Article 8 of Directive 2005/61/EC
Mag.a Roswitha Frieht
AGES
Mitglied
CTS Working Group
The Communication and Tracking System(CTS)
Working Group CMDh Human Medicines
CTS/CMDh
F
Richtlinie 2001/82/EG, Artikel 31
Mag.a Beate Gasser
AGES
Mitglied
Ad hoc group for the development of
implementing guidelines for Directive 2001/20/EC
relating to good clinical practice in the conduct of
clinical trials on medicinal products for human use
Ad hoc group for the development of
implementing guidelines for Directive 2001/20/EC
Ad hoc Group F
relating to good clinical practice in the conduct of
clinical trials on medicinal products for human use
Richtlinie 2001/20/EG
Dr. Stefan Strasser
AGES
Mitglied
GCP Group (Ad hoc group for the development of GCP Group (Ad hoc group for the development of
implementing guidelines for Directive 2001/20/EC implementing guidelines for Directive 2001/20/EC
GCP‐Group
relating to good clinical practice in the conduct of relating to good clinical practice in the conduct of
clinical trials on medicinal products for human use) clinical trials on medicinal products for human use)
F
Richtlinie 2001/20/EG
Dr.in Ilona Reischl
AGES
Mitglied
Notice to Applicants Working Group vet.
Notice to Applicants Working Group vet.
NtA‐V
F
Richtlinie 2001/82/EG
Mag. Alexander Ertl
AGES
Mitglied
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Veterinary
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Veterinary
CMDv
G
Richtlinie 2001/82/EG, Artikel 31
Mag.a Beate Gasser
AGES
Mitglied
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Veterinary
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Veterinary
CMDv
G
Richtlinie 2001/82/EG, Artikel 31
Mag.a Ines Lindner
AGES
stv. Mitglied
Regulation (EC) No 2006/2004 of the European
Parliament and of the Council of 27 October 2004
Verbraucherbehörden‐Kooperationsgesetz (VBKG,
on cooperation between national authorities
BGBl. I Nr. 148/2006) bzw. Verordnung
responsible for the enforcement of consumer
Behördenkooperation (EG) Nr. 2006/2004
protection laws (the Regulation on consumer
protection cooperation)
G
VBKG, BGBl. I Nr. 148/2006, Verordnung
Behördenkooperation (EG) Nr. 2006/2004
Mag. Thomas Reichhart
AGES
stv. Mitglied
Regulation (EC) No 2006/2004 of the European
Parliament and of the Council of 27 October 2004
Verbraucherbehörden‐Kooperationsgesetz (VBKG,
on cooperation between national authorities
BGBl. I Nr. 148/2006) bzw. Verordnung
responsible for the enforcement of consumer
Behördenkooperation (EG) Nr. 2006/2004
protection laws (the Regulation on consumer
protection cooperation)
G
VBKG, BGBl. I Nr. 148/2006, Verordnung
Behördenkooperation (EG) Nr. 2006/2004
Mag.a Martina Hofmann, LLM
AGES
stv. Mitglied
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Human
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Human
CMDh
G
Richtlinie 2001/83/EG, Artikel 27
Dr.in Ingeborg Gerngross
AGES
stv. Mitglied
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Human
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Human
CMDh
G
Richtlinie 2001/83/EG, Artikel 27
Dr. Jascha Johann Hörnisch
AGES
Mitglied
Expert Group 'Delegated act on safety features for Expert Group 'Delegated act on safety features for
E02719
medicinal products for human use'
medicinal products for human use'
F
Beschluss der DG Health and Food Safety
Mag. Markus Pongratz
AGES
Mitglied
National Contact point Clinical Trials Regulation
National Contact point Clinical Trials Regulation
F
Verordnung (EU) 536/2014
Dr. Stefan Strasser
AGES
Kontaktstelle
Notice to Applicants Working Group hum.
Notice to Applicants Working Group hum.
F
Richtlinie 2001/83/EG
Mag. Dr. Peter Platzer
AGES
Mitglied
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
NtA‐H
EC Gremien Medizinprodukte/ medical devices
Administrative Co‐operation Working Group (LVD Administrative Co‐operation Working Group (LVD
LVD ADCO
ADCO)
ADCO)
L_MEA_SGB_00QM_A50_21
Gültig ab: 03.06.2016
Seite 2/10
Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
Competent Authority Meeting beim
Ratsvorsitzenden
Meeting of the Competent Authorities for Medical
CAMD
Devices (CAMD)
F
Richtlinie 93/42/EWG, Article 20a
Dr. DI Ronald Bauer
AGES
stv. Mitglied
Competent Authority Meeting beim
Ratsvorsitzenden
Meeting of the Competent Authorities for Medical
CAMD
Devices (CAMD)
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
Co‐ordination von Joint Action (3rd Health
Programm)
Co‐ordination von Joint Action (3rd Health
Programm)
F
Directive 93/42/EEC
Mag.a Dr.in Heidrun Eberl
AGES
stv. Mitglied
Co‐ordination von Joint Action (3rd Health
Programm)
Co‐ordination von Joint Action (3rd Health
Programm)
F
Directive 93/42/EEC
Dr. Reinhard Berger
AGES
Mitglied
EU Working Group on Clinical Investigation and
Evaluation
EU Working Group on Clinical Investigation and
Evaluation
CIE
F
Richtlinie 93/42/EWG, Article 20a
Dr.in Violetta Zmuda
AGES
Mitglied
In Vitro Diagnostica Technical Group
In Vitro Diagnostica Technical Group
IVD Technical
F
Group
Richtlinie 93/42/EWG, Article 20a
Mag.a Dr.in Heidrun Eberl
AGES
stv. Mitglied
In Vitro Diagnostica Technical Group
IVD Technical
F
Group
Richtlinie 93/42/EWG, Article 20a
Regina Gassner‐Ober, MSc, MBA
AGES
Mitglied
In Vitro Diagnostica Technical Group
Internal Market for Products ‐ Market Surveillance Internal Market for Products ‐ Market Surveillance
IMP‐MSG
Group
Group
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
Market Surveillance Operation Group
Market Surveillance Operation Group
MSOG
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
MDEG Medical Devices Experts Group der EU
Kommission
MDEG‐Medical Device Expert Group
MDEG
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
Medical Devices Compliance and Enforcement
Group
Medical Devices Compliance and Enforcement
Group
COEN
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Vorsitz
Medical Devices Expert Group Vigilance
Medical Devices Expert Group Vigilance
MDEG VIG
F
Richtlinie 93/42/EWG, Article 20a
DI Christian Taylor
AGES
Mitglied
MDEG Classification / Borderline
MDEG B&C
F
Richtlinie 93/42/EWG, Article 20a
Dr. Reinhard Berger
AGES
Mitglied
New and emerging technologies on medical
devices working group
N&ET
F
Directive 93/42/EEC
DI Andreas Amon
AGES
Mitglied
Medical Devices Experts Group (MDEG)
Classification / Borderline
New and emerging technologies on medical
devices working group
Gremien der Europäischen Arzneimittelagentur/ committees and working groups of the European Medicines Agency
EMA Committees
Ausschuss für Tierarzneimittel
Ausschuss für Tierarzneimittel
Committee for Medicinal Products for Veterinary
Use
Committee for Medicinal Products for Veterinary
Use
CVMP
G
Regulation (EC) No 726/2004, Art. 56 (1)
Dr.in Barbara Zemann, MScTox, ERT
AGES
Mitglied
CVMP
G
Regulation (EC) No 726/2004, Art. 56 (1)
Dr.in Ulrike Heissenberger
AGES
stv. Mitglied
Ausschuss für pflanzliche Arzneimittel
Committee for Herbal Medicinal Products
HMPC
G
Richtlinie 2004/24/EG
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
Ausschuss für pflanzliche Arzneimittel
Committee for Herbal Medicinal Products
HMPC
G
Richtlinie 2004/24/EG
Mag.a Dr.in Astrid Obmann
AGES
stv. Mitglied
Ausschuss für Humanarzneimittel
Committee for Human Medicinal Products
CHMP
G
Regulation (EC) No 726/2004, Art. 56 (1)
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
Ausschuss für Humanarzneimittel
Committee for Human Medicinal Products
CHMP
G
Regulation (EC) No 726/2004, Art. 56 (1)
Dr.in Milena Stain
AGES
stv. Mitglied
Pädiatrieausschuss
Paediatric Committee
PDCO
G
Regulation (EC) No 1901/2006
DDr. Karl‐Heinz Huemer
AGES
Mitglied
Ausschuss für neuartige Therapien
Committee for Advanced Therapies
CAT
G
Regulation (EC) No 1394/2007
Dr.in Ilona Reischl
AGES
Mitglied
Ausschuss für Risikobewertung im Bereich der
Pharmakovigilanz
Pharmacovigilance Risk Assessment Committee
PRAC
G
Regulation (EC) No 1235/201
Dr. Jan Neuhauser
AGES
stv. Mitglied
F
Regulation (EC) No 726/2004, Art. 56 (2)
Mag. Andreas Krassnigg
AGES
Mitglied
EMA Working Parties
L_MEA_SGB_00QM_A50_21
Ad hoc Working Group GMP Inspectors
Ad hoc Working Group GMP Inspectors
Adaptive Pathways Discussion Group
Adaptive Pathways Discussion Group
APDG
I
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
Pharmacovigilance Inspector's Working Group
Pharmacovigilance Inspector's Working Group
PhV IWG
F
Regulation (EC) No 726/2004, Art. 56 (2)
Mag.a Katharina Weber
AGES
Mitglied
Pharmacovigilance Inspector's Working Group
Pharmacovigilance Inspector's Working Group
PhV IWG
F
Regulation (EC) No 726/2004, Art. 56 (2)
Mag.a Dr.in Verena Plattner
AGES
stv. Mitglied
Blood Products Working Party
Blood Products Working Party
BPWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Brigitte Müller
AGES
Mitglied
Blood Products Working Party
Blood Products Working Party
BPWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Daniela Philadelphy
AGES
Mitglied
CHMP Biologics Working Party
CHMP Biologics Working Party
BWP
F
Regulation (EC) No 726/2004, Art. 56 (2)
Dr.in Ilona Reischl
AGES
Mitglied
CHMP Biologics Working Party
CHMP Biologics Working Party
BWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Christian Mayer
AGES
stv. Mitglied
CHMP Biostatistics Working Party
CHMP Biostatistics Working Party
BSWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Christian Gartner
AGES
Mitglied
CHMP Biostatistics Working Party
CHMP Biostatistics Working Party
BSWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Thomas Lang
AGES
Mitglied
CHMP BWP ad hoc Influenza WP
CHMP BWP ad hoc Influenza WP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Petra Falb
AGES
Mitglied
CHMP BWP Plasma Master File Drafting Group
CHMP BWP Plasma Master File Drafting Group
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martina Joseph
AGES
Mitglied
CHMP Pharmacokinetic WP
CHMP Pharmacokinetic WP
PKWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Jan Neuhauser
AGES
Mitglied
CHMP Pharmacokinetic WP
CHMP Pharmacokinetic WP
PKWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Karin Kundler
AGES
Beobachter
CHMP Safety Working Party
CHMP Safety Working Party
SWP‐H
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. DI, MDRA Günter Waxenecker
AGES
Mitglied
CHMP Safety Working Party
CHMP Safety Working Party
SWP‐H
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Klaudia Hettinger
AGES
stv. Mitglied
CHMP Scientific Advice WP
CHMP Scientific Advice WP
SAWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Thomas Lang
AGES
Mitglied
Gültig ab: 03.06.2016
Seite 3/10
Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
CHMP Scientific Advice WP
CHMP Scientific Advice WP
SAWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
CHMP Scientific Advice WP
CHMP Scientific Advice WP
SAWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Christian Gartner
AGES
stv. Mitglied
CHMP Scientific Advice WP
CHMP Scientific Advice WP
SAWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
DDr. Karl‐Heinz Huemer
AGES
Mitglied
CHMP Scientific Advice WP
CHMP Scientific Advice WP
SAWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Andreas Kirisits, MSc
AGES
stv. Mitglied
CHMP Vaccine Working Party (VWP)
CHMP Vaccine Working Party (VWP)
VWP
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Petra Schlick
AGES
Mitglied
CHMP/CVMP QWP core team
CHMP/CVMP QWP core team
F
Regulation (EC) No 726/2004, Art. 57 (1)
DI in Susanne Stotter
AGES
Mitglied
CHMP/CVMP: Quality Working Party
CHMP/CVMP Quality Working Party
F
Regulation (EC) No 726/2004, Art. 57 (1)
DI in Susanne Stotter
AGES
Mitglied
CHMP‐Associated QRD
CHMP‐Associated QRD
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Petra Wiesinger
AGES
Mitglied
Consultative Group on Veterinary
Pharmacovigilance Systems
Consultative Group on Veterinary
Pharmacovigilance Systems
CGVPhS
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a vet.med. Brigitte Hauser
AGES
Experte/in
CVMP Efficacy Working Party
CVMP Efficacy Working Party
EWP‐V
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Anja Kotschwar
AGES
Mitglied
CVMP Immunologicals Working Party
CVMP Immunologicals Working Party
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Petra Falb
AGES
Mitglied
CVMP Safety Working Party
CVMP Safety Working Party
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Barbara Zemann, MScTox, ERT
AGES
Mitglied
EMA Innovation Network
EMA Innovation Network
I
Regulation (EC) No 726/2004, Art. 56 (2)
Dr.in Ilona Reischl
AGES
Mitglied
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ulrike Michel
AGES
Mitglied
QWP
SWP‐V
ERA Experts EU Network (human pharmaceuticals) ERA Experts EU Network (human pharmaceuticals)
GCP Inspectors Working Group
GCP Inspectors Working Group
GCP IWG
F
Regulation (EC) No 726/2004, Art. 56 (2)
DI Matthias Loibl
AGES
Mitglied
GCP Inspectors Working Group
GCP Inspectors Working Group
GCP IWG
F
Regulation (EC) No 726/2004, Art. 56 (2)
Dr.in Ilona Reischl
AGES
stv. Mitglied
GMDP Inspectors Working Group
GMDP Inspectors Working Group
GMDP IWG
F
Regulation (EC) No 726/2004, Art. 56 (2)
Mag. Andreas Krassnigg
AGES
Mitglied
Guideline Consistency Group
Guideline Consistency Group
F
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
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
Joint Committee for Medicinal Products for
Veterinary Use/Committee for Medicinal Products
for Human Use Ad‐hoc Expert Group on the
JEG 3Rs
Application of the 3Rs in Regulatory Testing of
Medicinal Products
F
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Barbara Zemann, MScTox, ERT
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
EMA Pandemic Influenza Crisis Management Plan
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
EMA Pandemic Influenza Crisis Management Plan
Dr.in Brigitte Müller
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
EMA Pandemic Influenza Crisis Management Plan
Dr. DI, MDRA Günter Waxenecker
AGES
Mitglied
Pharmacovigilance Working Party (veterinary)
Pharmacovigilance Working Party (veterinary)
PhVWP‐V
F
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a vet.med. Brigitte Hauser
AGES
Experte/in
Working Party on European Union Monographs
and European Union List
Working Party on European Union Monographs
and European Union List
MLWP
I
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
EMA Kontaktstellen / contact points
Contact point for PMF Baxter
Contact point for PMF Baxter
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martina Joseph
AGES
Kontaktstelle
EMA National contact point for referrals
EMA National contact point for referrals
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Rudolf Schranz
AGES
Kontaktstelle
EMA National contact point for referrals
EMA National contact point for referrals
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a pharm. Dr.in rer. nat. Ulrike Rehberger AGES
Kontaktstelle
EMA National contact point for referrals
EMA National contact point for referrals
I
Regulation (EC) No 726/2004, Art. 57 (1)
Ing.in Veronika Iro
AGES
Kontaktstelle
EMA PMF Coordinator
PMF Coordinator
F
Richtlinie 2001/83/EG
Dr.in Ilona Reischl
AGES
Kontaktstelle
European Experts Database Contact Point
European Experts Database Contact Point
I
Regulation (EC) No 726/2004, Art. 57 (1)
Denise Hörmann
AGES
Kontaktstelle
European Experts Database Contact Point
European Experts Database Contact Point
I
Regulation (EC) No 726/2004, Art. 57 (1)
Stefanie Rauscher
AGES
Kontaktstelle
Name Review Group (NRG)
Name Review Group (NRG)
NRG
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Mag.a Ursula Ladstädter
AGES
Mitglied
Name Review Group (NRG) Contact Point
Name Review Group (NRG) Contact Point
NRG
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Mag.a Ursula Ladstädter
AGES
Kontaktstelle
Name Review Group (NRG) Contact Point
Name Review Group (NRG) Contact Point
NRG
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Rosemarie Potisk
AGES
Kontaktstelle
National Contact point Clinical Trials Regulation
National Contact point Clinical Trials Regulation
I
Regulation (EU) No 536/2014
Dr.in Ilona Reischl
AGES
Kontaktstelle
Nationaler Contact Point für Pandemie
National Contact Point for Pandemic Scenario
I
EU Pandemic Preparedness Plan
Mag.a Petra Falb
AGES
Kontaktstelle
Nationaler Contact Point für Pandemie
National Contact Point for Pandemic Scenario
I
EU Pandemic Preparedness Plan
Mag.a Beate Gasser
AGES
Kontaktstelle
EMA ExpertInnen/ European Experts
L_MEA_SGB_00QM_A50_21
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.René Anour
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI Julia‐Verena Bacher
AGES
Experte/in
Gültig ab: 03.06.2016
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Bezeichnung des Gremiums
(deutsch)
L_MEA_SGB_00QM_A50_21
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. DI Ronald Bauer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Christoph Baumgärtel, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Gerhard Beck
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Mahdi Ben Cheikh
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Viviane Benetka
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Isabella Berger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Richard Cejka‐Scheidl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Dominika Chrusciel
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Christinane Cserveny, BSc, BVSc, MRCVS
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Zehra Dzanic
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Sonja Ernsthofer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Petra Falb
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Gabriela Fischer‐Mayer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Christian Gartner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Beate Gasser
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ingeborg Gerngross
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Petra Günter‐Stadlmaier
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a vet.med. Brigitte Hauser
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Katharina Hausteiner‐Melichar
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ulrike Heissenberger
AGES
stv. Mitglied
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Irmtraud Held
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DIDr. Wolfgang Herzog
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Klaudia Hettinger
AGES
stv. Mitglied
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Mirjam Hinterleitner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Gernot Hirn
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Simone Hofbauer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Martina Hofmann, LLM
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Claudia Baranyi
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Jascha Johann Hörnisch
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Sonja Hrabcik
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DDr. Karl‐Heinz Huemer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martina Joseph
AGES
Kontaktstelle
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Jan Joseph
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI (FH) Christoph Kefeder, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Andreas Kirisits, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Caroline Kleber
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Alexander Knieps
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Sabine Koper
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Anja Kotschwar
AGES
Mitglied
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Andreas Krassnigg
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Karin Kundler
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Mag.a Ursula Ladstädter
AGES
Experte/in
Gültig ab: 03.06.2016
Seite 5/10
Bezeichnung des Gremiums
(deutsch)
L_MEA_SGB_00QM_A50_21
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Thomas Lang
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Univ.Prof.in Dr.in Andrea Laslop
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Stephan Lehr
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Manuela Leitner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Ines Lindner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI, Matthias Loibl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Marianne Lunzer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Beate Maichel
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Christine Meissner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ulrike Michel
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Leonhard‐Key Mien
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ramona Mirzaei
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Manuela Mondl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Brigitte Müller
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Jan Neuhauser
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Astrid Obmann
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Daniela Philadelphy
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI (FH) Patrick Pichler
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Verena Plattner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Dr. Peter Platzer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Karin Pöllitzer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Markus Pongratz
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Rosemarie Potisk
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Verena Pötsch
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Claudia Pramesberger, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Claudia Preßl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Dieter Pullirsch
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Florian Rauchensteiner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Sofie Regner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ulrike Rehberger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martina Reichelt
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Thomas Reichhart
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Roland Reimann
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Birgit Reinprecht
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Ilona Reischl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Dr. Olga Rögelsperger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Lisa Rosner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Gabriele Rothmüller
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI Heidemarie Schindl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Katrin Schlager, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Petra Schlick
AGES
Mitglied
Gültig ab: 03.06.2016
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Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag. Rudolf Schranz
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Iria Schubert
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Alexandra Seifner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Sevetlana Seiter
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martine Sernetz
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DIin Dr.in Doris Sommer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Corina Spreitzer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Martin Spruth
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Milena Stain
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Michaela Stelzhammer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI in Susanne Stotter
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Stefan Strasser
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI Klaus Stüwe
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Brigitte Tarasiewicz
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Martine Trauffler
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Yu‐ting Tseng
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Barbara Tucek, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Dr.in Christine Vaculik
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. Thomas Wächter
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr. DI, MDRA Günter Waxenecker
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Mag.a Katharina Weber
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Johanna Wernsperger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Petra Wiesinger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Daniela Wöhrer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Susanne Wolf, MPH
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Tanja Zahlner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Barbara Zemann, MScTox, ERT
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Dr.in Elvira Zimre‐Grabensteiner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
Ing. Ingrid Zlabinger, BSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Regulation (EC) No 726/2004, Art. 57 (1)
DI, Michael Zwitkovits, MSc
AGES
Experte/in
CO‐Rapporteur Celvapan
CO‐Rapporteur Celvapan
I
Richtlinie 2001/83/EG
Univ.Prof.in Dr.in Andrea Laslop
AGES
Experte/in
Assessor for the evaluation of a pandemic
influenza vaccine
Assessor for the evaluation of a pandemic
influenza vaccine
I
EMA Pandemic Influenza Crisis Management Plan
Mag.a Petra Falb
AGES
Experte/in
Assessor for the evaluation of a pandemic
influenza vaccine
Assessor for the evaluation of a pandemic
influenza vaccine
I
EMA Pandemic Influenza Crisis Management Plan
Mag. Thomas Lang
AGES
Experte/in
Assessor for the evaluation of a pandemic
influenza vaccine
Assessor for the evaluation of a pandemic
influenza vaccine
I
EMA Pandemic Influenza Crisis Management Plan
Dr.in Brigitte Müller
AGES
Experte/in
Assessor for the evaluation of a pandemic
influenza vaccine
Assessor for the evaluation of a pandemic
influenza vaccine
I
EMA Pandemic Influenza Crisis Management Plan
Dr. DI, MDRA Günter Waxenecker
AGES
Experte/in
Gemeinsame Arbeitsgruppen EMA/HMA / joint committees and working groups EMA/HMA
L_MEA_SGB_00QM_A50_21
Common European Submission Plattform
Common European Submission Plattform
CESP
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
eCTD Maintenance Group
eCTD Maintenance Group
eCTD MG
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
electronic Application Form Maintenance Group
electronic Application Form Maintenance Group
eAF MG
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
eSubmission Change Management Board
eSubmission Change Management Board
eSubmission
CMB
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
EU Network Training Center
EU Network Training Center
EU NTC
F
HMA Mandat
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Vorsitz
Gültig ab: 03.06.2016
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Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
EU Network Training Center
EU Network Training Center
Eudra GMP IT‐Subgroup
Akronym /
Abbrev.
EU NTC
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
F
HMA Mandat
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
Eudra GMP IT‐Subgroup
F
EU Telematics programme
Mag.a Karin Pöllitzer
AGES
Mitglied
EudraCT DWH Subgroup & Power User
EudraCT DWH Subgroup & Power User
F
EU Telematics programme
Dr. Stefan Strasser
AGES
Mitglied
EudraVigilance Telematic Implementation Group
EudraVigilance Telematic Implementation Group
EV TIG
F
EU Telematics programme
Mag. Rudolf Schranz
AGES
Mitglied
EUTCT Full Group
European Union Telematics Controlled Terms
(EUTCT) Full Group
EUTCT FG
F
EU Telematics programme
Mag. Markus Pongratz
AGES
Mitglied
EUTCT Full Group
European Union Telematics Controlled Terms
(EUTCT) Full Group
EUTCT FG
F
EU Telematics programme
Dr.in Mag.a Ursula Ladstädter
AGES
stv. Mitglied
IT‐Directors Group
IT‐Directors Group
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
Telematics Enterprise Architecture Board
Telematics Enterprise Architecture Board
TEAB
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
Heads of Medicines Agencies
Active Substance Master File Working Group des
CMDh
Active Substance Master File Working Group of
the CMDh
ASMF WG
F
HMA Mandat
Mag.a Beate Gasser
AGES
Mitglied
Benchmarking of European Medicines Agencies
(BEMA) Assessor
Benchmarking of European Medicines Agencies
(BEMA) Assessor
BEMA
I
HMA Mandat
DI Klaus Stüwe
AGES
Experte/in
Benchmarking of European Medicines Agencies
(BEMA) Steering Group
Benchmarking of European Medicines Agencies
(BEMA) Steering Group
BEMA SG
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Clinical Trials Facilitation Group
Clinical Trials Facilitation Group
CTFG
F
HMA Mandat
Dr.in Corina Spreitzer
AGES
stv. Mitglied
Clinical Trials Facilitation Group
Clinical Trials Facilitation Group
CTFG
F
HMA Mandat
Dr. Stefan Strasser
AGES
MItglied
European Medicines Agencies Co‐operation on
Legal and Legislative Issues
European Medicines Agencies Co‐operation on
Legal and Legislative Issues
EMACOLEX
F
HMA Mandat
Mag. Thomas Reichhart
AGES
Mitglied
European Medicines Agencies Co‐operation on
Legal and Legislative Issues
European Medicines Agencies Co‐operation on
Legal and Legislative Issues
EMACOLEX
F
HMA Mandat
Mag.a Martina Hofmann, LLM
AGES
stv. Mitglied
I
HMA Mandat
DI in Susanne Stotter
AGES
Mitglied
Expert Group of Pharmaceutical Quality Assessors Expert Group of Pharmaceutical Quality Assessors
GCP Inspectors Working Group/CMDh Working
Party
GCP Inspectors Working Group/CMDh Working
Party
GCP IWG/CMD F
HMA Mandat
Dr.in Isabella Berger
AGES
Mitglied
GCP Inspectors Working Group/CMDh Working
Party
GCP Inspectors Working Group/CMDh Working
Party
GCP IWG/CMD F
HMA Mandat
Dr. Jascha Johann Hörnisch
AGES
Mitglied
Heads of national Agencies
Heads of national Agencies
HMA
F
HMA Mandat
DI, Dr.in Christa Wirthumer‐Hoche
AGES
Mitglied
HMA Task Force FMD
HMA TF Falsified Medicines Directive
F
HMA Mandat
Mag. Hannes Würkner
AGES
Mitglied
HMA Working Group of Communication
Professionals
HMA Working Group of Communication
Professionals
F
HMA Mandat
Dr. Christoph Baumgärtel, MSc
AGES
Mitglied
Homoepathic Medicinal Products Working Group
Homoepathic Medicinal Products Working Group
HMPWG
F
HMA Mandat
Mag.a Dr.in Astrid Obmann
AGES
stv. Mitglied
Homoepathic Medicinal Products Working Group
Homoepathic Medicinal Products Working Group
HMPWG
F
HMA Mandat
Mag.a Dr.in Ingrid Werner
AGES
Mitglied
HMA Mandat
Mag.a Caroline Kleber
AGES
Experte/in
HMA Mandat
DI in Susanne Stotter
AGES
Mitglied
Variation
Joint CMDh/CMDv Working Party on the Variation Joint CMDh/CMDv Working Party on the Variation
Regulation
F
Regulation
Regulation
WP
Joint CMDh/CMDv Working Party on Variation
Joint CMDh/CMDv Working Party on Variation
Variation Subg F
Regulation
Regulation
Pharmacovigilance Audit Facilitation Group
Pharmacovigilance Audit Facilitation Group
PAFG
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Working Group of Enforcement Officers
Working Group of Enforcement Officers
WGEO
F
HMA Mandat
Mag. Hannes Würkner
AGES
Mitglied
Working Group of Quality Managers
Working Group of Quality Managers
WGQM
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Council of Europe Resolution AP‐CSP (07) 1
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
DIDr. Wolfgang Herzog
AGES
Mitglied
EDQM
Europäische Arzneibuchkommission / European Pharmacopoeia Commission
EDQM Technical Advisory Board
EDQM Technical Advisory Board
TAB
I
EDQM WG "Extracts"
EDQM WG "Extracts"
EDQM EXT
I
EDQM WG "Microbiological quality of herbal
drugs"
EDQM WG "Microbiological quality of herbal
drugs"
EDQM WG "Traditional Chinese Medicines"
EDQM TCM
AGES
Mitglied
I
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
I
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Univ.Doz. Mag. Dr. Reinhard Länger
AGES
Mitglied
Mag. Roman Macas
AGES
stv. Mitglied
Europäische Arzneibuchkommission
EDQM
G
Convention on the Elaboration of a European
Pharmacopoeia (BGBl. Nr. 181/1979)
Europäische Arzneibuchkommission
EDQM
G
Convention on the Elaboration of a European
Pharmacopoeia (BGBl. Nr. 181/1979)
Mag. Josef Trenker
AGES
stv. Mitglied
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Mag.a Dr.in Ingrid Werner
AGES
Mitglied
Mag.a Claudia Baranyi
AGES
Mitglied
Homoeopathic Manufacturing Methods Group
Homoeopathic Manufacturing Methods Group
HMM
Ph. Eur. Expert group 12
Ph. Eur. Expert group 12
Group 12
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Ph. Eur. Expert Group 15 (Vakzine)
Ph. Eur. Expert Group 15 (Vaccines)
Group 15
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
DI Heidemarie Schindl
AGES
Mitglied
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Dr. Dieter Pullirsch
AGES
Mitglied
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
DI (FH) Christoph Kefeder, MSc
AGES
Mitglied
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
DI (FH) Christoph Kefeder, MSc
AGES
Mitglied
Ph. Eur. Expert Group 15 (veterinär‐Vakzine)
L_MEA_SGB_00QM_A50_21
EDQM WG "Traditional Chinese Medicines"
EDQM MQH
Univ.Doz. Mag. Dr. Reinhard Länger
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Ph. Eur. Expert Group 15 (veterinary vaccines)
Ph. Eur. Expert Group 6B
Ph. Eur. Expert Group 6B
Ph. Eur. Expert Group Allergen Products
Ph. Eur. Expert Group Allergen Products
Group 15V
6B
Gültig ab: 03.06.2016
Seite 8/10
Bezeichnung des Gremiums
(deutsch)
Ph. Eur. Expert Group Gene Therapy Products
Name of working group
(English)
Akronym /
Abbrev.
Ph. Eur. Expert Group Gene Therapy Products
Institution /
custodian
organisation
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Vertreter/in der AGES /
AGES representative
Funktion /
function
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Dr. Dieter Pullirsch
AGES
Mitglied
Dr. Dieter Pullirsch
AGES
Mitglied
Ph. Eur. Expert Group Monoclonal Antibodies
Ph. Eur. Expert Group Monoclonal Antibodies
MAB
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Ph. Eur. Working Party P4 biologicals
Ph. Eur. Working Party P4 biologicals
P4Bio
F
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
Dr. Dieter Pullirsch
AGES
Mitglied
EDQM Ad hoc committee
AHC
I
Council of Europe Resolution AP‐CSP (07) 1
DIDr. Wolfgang Herzog
AGES
Mitglied
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
DIDr. Wolfgang Herzog
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Mag.a Claudia Baranyi
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Dr. Jan Joseph
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Dr. Alexander Knieps
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Dr.in Manuela Leitner
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Dr.in Beate Maichel
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Dr. Florian Rauchensteiner
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Mag. Roland Reimann
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
DIin Dr.in Doris Sommer
AGES
Experte/in
EDQM Expertengruppe „Certification of Suitability EDQM Expert group „Certification of Suitability of
of Monographs for the European Pharmacopoeia“ Monographs of the European Pharmacopoeia“
I
Council of Europe Resolution AP‐CSP (07) 1
Mag.a Yu‐ting Tseng
AGES
Experte/in
National contact point for CEP
National contact point for CEP
I
Council of Europe Resolution AP‐CSP (07) 1
DIDr. Wolfgang Herzog
AGES
Kontaktstelle
National contact point for CEP
National contact point for CEP
I
Council of Europe Resolution AP‐CSP (07) 1
Mag.a Claudia Baranyi
AGES
Kontaktstelle
National contact point for CEP
National contact point for CEP
I
Council of Europe Resolution AP‐CSP (07) 1
Mag. Dr. Peter Platzer
AGES
Kontaktstelle
National contact point for CEP
National contact point for CEP
I
Council of Europe Resolution AP‐CSP (07) 1
Mag.a Martina Unteregger
AGES
Kontaktstelle
National contact point for CEP
National contact point for CEP
I
Council of Europe Resolution AP‐CSP (07) 1
Mag.a Martina Unteregger
AGES
Kontaktstelle
Certification
EDQM Ad hoc committee
OMCL Network
Auditor MJA OMCL‐Network
Auditor Mutual Joint Audit (MJA) Official
Medicines Control Laboratory (OMCL)‐Network
MJA OMCL NetI
Beschluss des GeON (General OMCL Network)
DI Thomas Lang
AGES
Experte/in
Auditor MJA OMCL‐Network
Auditor Mutual Joint Audit (MJA) Official
Medicines Control Laboratory (OMCL)‐Network
MJA OMCL NetI
Beschluss des GeON (General OMCL Network)
DI Klaus Stüwe
AGES
Experte/in
Counterfeit/Illegal Medicines WG
Counterfeit/Illegal Medicines WG
F
Beschluss des GeON (General OMCL Network)
Dr. Andreas Hackl
AGES
Mitglied
Gene Therapy Products (GTP) Working Group
Gene Therapy Products (GTP) Working Group
F
Beschluss des GeON (General OMCL Network)
Dr. Dieter Pullirsch
AGES
Mitglied
OMCL Communication Group
OMCL Communication Group
F
Beschluss des GeON (General OMCL Network)
DI Thomas Lang
AGES
Mitglied
OMCL Contact für Probennahme zentral
zugelassener Asp
OMCL Contact CAP sampling
I
Beschluss des GeON (General OMCL Network)
DI Reinhard Stark
AGES
Kontaktstelle
OMCL Contact OCABR Blutprodukte
OMCL Contact OCABR blood derivatives
I
Beschluss des GeON (General OMCL Network)
DI (FH) Christoph Kefeder, MSc
AGES
Kontaktstelle
OMCL Contact OCABR Impfstoffe
OMCL Contact OCABR vaccines
I
Beschluss des GeON (General OMCL Network)
DI Heidemarie Schindl
AGES
Kontaktstelle
OMCL Kontakt CAP‐Testing und Contracting
(Hum./Biol. und Vet./Biol.)
OMCL Contact for CAP Testing (Hum/Biol. and
vet/Biol.)
I
Beschluss des GeON (General OMCL Network)
Dr. Dieter Pullirsch
AGES
Kontaktstelle
OMCL Kontakt CAP‐Testing und Contracting
(Hum./Chem. und Vet./Chem.)
OMCL Contact for CAP Testing (Hum/Chem. and
vet/Chem.)
I
Beschluss des GeON (General OMCL Network)
DI Thomas Lang
AGES
Kontaktstelle
OMCL Kontakt MRP/DCP‐Testing
OMCL Contact for MRP/DCP Testing
I
Beschluss des GeON (General OMCL Network)
DI Thomas Lang
AGES
Kontaktstelle
GTP WG
OMCL
andere Gremien des EDQM / other committees and working groups of EDQM
Committee of experts on the classification of
medicines as regards their supply
Committee of experts on the classification of
medicines as regards their supply
CD‐P‐PH/PHO F
Council of Europe CM/Res(2011)24
Mag. Markus Pongratz
AGES
Mitglied
Standard Terms Working Party
Standard Terms Working Party
ST WP
Convention on the Elaboration of a European
Pharmacopoeia (BGBl. Nr. 181/1979)
Mag. Markus Pongratz
AGES
Mitglied
Dr. Reinhard Berger
AGES
Mitglied
Mag.a Roswitha Frieht
AGES
Kontaktstelle
F
andere europäische Gremien / other European committees and working groups
Deutsche Arbeitsgemeinschaft Medizinprodukte
European Haemovigilance Network
L_MEA_SGB_00QM_A50_21
European Haemovigilance Network
AGMP
I
EHN
F
Zusammenarbeit der deutschsprachigen
Marktüberwachungsbehörden
Gültig ab: 03.06.2016
Seite 9/10
Bezeichnung des Gremiums
(deutsch)
Name of working group
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
Experte für European Food Safety Authority (EFSA)
Expert of the European Food Safety Authority
(EFSA)
NC3Rs/MHRA recovery animals working group
NC3Rs/MHRA recovery animals working group
I
Redaktionskonferenz Deutschsprachige Ausgabe
Europäisches Arzneibuch
Redaktionskonferenz Deutschsprachige Ausgabe
Europäisches Arzneibuch
F
F
EFSA Expert
Wissenschaftsforum/ Komitee der Europäischen
Behörde für Lebensmittelsicherheit
I
Rechtsgrundlage / legal basis
(wenn anwendbar / as applicable)
Verordnung (EG) Nr. 178/2002
Vertreter/in der AGES /
AGES representative
Funktion /
function
Dr. Christoph Baumgärtel, MSc
AGES
Experte/in
Mag.a Dr.in Klaudia Hettinger
AGES
stv. Mitglied
AB‐Gesetz
Mag. Josef Trenker
AGES
Mitglied
Verordnung (EG) Nr. 178/2002
Univ.Prof.in Dr.in Andrea Laslop
AGES
Mitglied
internationale Gremien / international committees and working groups
L_MEA_SGB_00QM_A50_21
Arbeitsgruppe der Organisation für wirtschaftliche
Zusammenarbeit und Entwicklung (OECD)
OECD GLP Working Party
betreffend GLP
OECD GLP WG F
OECD Beitrittserklärung
Dr. DI Ronald Bauer
AGES
Mitglied
Expert Circle der PIC/S für Computergestützte
Systeme
PIC/S Expert Circle on Computerized Systems
EC CS
F
PIC/S Vertrag
Dr. DI Ronald Bauer
AGES
Mitglied
National focal point
National focal point
I
Annahme Internationaler Gesundheitsvorschriften (2005) Mag. Thomas Reichhart
AGES
Kontaktstelle
Pharmaceutical Inspection
Convention/Scheme/Management Committee
Pharmaceutical Inspection
Convention/Scheme/Management Committee
F
PIC/S Vertrag
AGES
Mitglied
WHO‐Inspektor
World Health Organization (WHO)‐Inspector
I
Annahme Internationaler Gesundheitsvorschriften (2005) Dr. DI Ronald Bauer
AGES
Experte/in
PIC/S
Gültig ab: 03.06.2016
Mag. Andreas Krassnigg
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