L A50 Gremien MEA

Transcrição

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
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
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
AGES
Mitglied
Codex‐Unterkommission
Nahrungsergänzungsmittel
UK "NEM"
G
AGES
Mitglied
Codex‐Unterkommission Tee und teeähnliche
Erzeugnisse
UK "B31"
F
AGES
Mitglied
div. Lehrbeauftragte
AGES
Lehrbeauftragte
/r
div. Lehrbeauftragte
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
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
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
Dr. Reinhard Berger
AGES
Mitglied
Dr. Reinhard Berger
AGES
Mitglied
ÖNORM Fachnormungsausschuss Medizingeräte
FNA‐MG
G
Österr. Plattform für Gesundheitskompetenz
ÖPGK
F
Art. 15a Bundesverfassungsgesetz (BV‐G)
AGES
Mitglied
österreichische Arzneibuchkommission
ÖAB Komm.
G
AB‐Gesetz
DI Thomas Lang
AGES
stv. Mitglied
ÖAB Komm.
G
AB‐Gesetz
AGES
Mitglied
ÖAB Komm.
G
AB‐Gesetz
Mag. Roman Macas
AGES
Mitglied
ÖAB Komm.
G
AB‐Gesetz
Mag.a Dr.in Ingrid Werner
AGES
stv. Mitglied
Österreichische Gesellschaft für Arzneimittel in der
Psychiatrie
ÖAMSP
I
AGES
Mitglied
Österreichische Gesellschaft für Kinder‐ und
Jugendheilkunde
ÖGKJ
I
DDr. Karl‐Heinz Huemer
AGES
Mitglied
APHAR
I
AGES
Mitglied
F
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
(deutsch)
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
AGES representative
Funktion /
function
Rezeptpflichtkommission
G
§ 5 Rezeptpflichtgesetz
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
AGES
Mitglied
F
AGES
Mitglied
F
AGES
Vorsitz
Wissenschaftlicher Beirat Pandemie
G
Pandemieplan, Seuchengesetz
AGES
Mitglied
G
Mag.a Petra Falb
AGES
Mitglied
G
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
G
75/320/EEC: Council Decision of 20 May 1975 setting up a
pharmaceutical committee
AGES
stv. Mitglied
G
AGES
Mitglied
G
Mag.a Martina Hofmann, LLM
AGES
stv. Mitglied
Verwaltungsrat der europäischen
Arzneimittelagentur
European Medicines Agency Management Board
EMA ManagemG
Regulation (EC) No 726/2004, Art 56 (1.g)
AGES
Vorsitz
Arbeitsgruppe Hämovigilanz
SARE Working Group
SARE
F
Article 8 of Directive 2005/61/EC
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
Dr.in Ilona Reischl
AGES
Mitglied
Notice to Applicants Working Group vet.
Notice to Applicants Working Group vet.
NtA‐V
F
Mag. Alexander Ertl
AGES
Mitglied
Coordination Group for Mutual Recognition and
Decentralised Procedures ‐ Veterinary
CMDv
G
Mag.a Beate Gasser
AGES
Mitglied
CMDv
G
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
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
protection laws (the Regulation on consumer
protection cooperation)
G
VBKG, BGBl. I Nr. 148/2006, Verordnung
AGES
stv. Mitglied
Decentralised Procedures ‐ Human
CMDh
G
Dr.in Ingeborg Gerngross
AGES
stv. Mitglied
CMDh
G
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
AGES
Mitglied
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
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)
Gültig ab: 03.06.2016
Seite 2/10
(deutsch)
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
AGES representative
Funktion /
function
Competent Authority Meeting beim
Ratsvorsitzenden
Meeting of the Competent Authorities for Medical
CAMD
Devices (CAMD)
F
Dr. DI Ronald Bauer
AGES
stv. Mitglied
Competent Authority Meeting beim
Ratsvorsitzenden
Meeting of the Competent Authorities for Medical
CAMD
Devices (CAMD)
F
Dr. Reinhard Berger
AGES
Mitglied
Co‐ordination von Joint Action (3rd Health
Programm)
Programm)
F
Directive 93/42/EEC
Mag.a Dr.in Heidrun Eberl
AGES
stv. Mitglied
Programm)
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
Dr.in Violetta Zmuda
AGES
Mitglied
In Vitro Diagnostica Technical Group
IVD Technical
F
Group
Mag.a Dr.in Heidrun Eberl
AGES
stv. Mitglied
IVD Technical
F
Group
Regina Gassner‐Ober, MSc, MBA
AGES
Mitglied
Internal Market for Products ‐ Market Surveillance Internal Market for Products ‐ Market Surveillance
IMP‐MSG
Group
Group
F
Dr. Reinhard Berger
AGES
Mitglied
Market Surveillance Operation Group
Market Surveillance Operation Group
MSOG
F
Dr. Reinhard Berger
AGES
Mitglied
MDEG Medical Devices Experts Group der EU
Kommission
MDEG‐Medical Device Expert Group
MDEG
F
Dr. Reinhard Berger
AGES
Mitglied
Medical Devices Compliance and Enforcement
Group
Medical Devices Compliance and Enforcement
Group
COEN
F
Dr. Reinhard Berger
AGES
Vorsitz
Medical Devices Expert Group Vigilance
Medical Devices Expert Group Vigilance
MDEG VIG
F
DI Christian Taylor
AGES
Mitglied
MDEG Classification / Borderline
MDEG B&C
F
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
Dr.in Ulrike Heissenberger
AGES
stv. Mitglied
Ausschuss für pflanzliche Arzneimittel
Committee for Herbal Medicinal Products
HMPC
G
AGES
Mitglied
Ausschuss für pflanzliche Arzneimittel
Committee for Herbal Medicinal Products
HMPC
G
AGES
stv. Mitglied
Ausschuss für Humanarzneimittel
Committee for Human Medicinal Products
CHMP
G
AGES
Mitglied
Ausschuss für Humanarzneimittel
Committee for Human Medicinal Products
CHMP
G
Dr.in Milena Stain
AGES
stv. Mitglied
Pädiatrieausschuss
Paediatric Committee
PDCO
G
Regulation (EC) No 1901/2006
AGES
Mitglied
Ausschuss für neuartige Therapien
Committee for Advanced Therapies
CAT
G
Dr.in Ilona Reischl
AGES
Mitglied
Ausschuss für Risikobewertung im Bereich der
Pharmakovigilanz
Pharmacovigilance Risk Assessment Committee
PRAC
G
Dr. Jan Neuhauser
AGES
stv. Mitglied
F
AGES
Mitglied
EMA Working Parties
Ad hoc Working Group GMP Inspectors
Ad hoc Working Group GMP Inspectors
Adaptive Pathways Discussion Group
Adaptive Pathways Discussion Group
APDG
I
AGES
Mitglied
Pharmacovigilance Inspector's Working Group
PhV IWG
F
Mag.a Katharina Weber
AGES
Mitglied
PhV IWG
F
Mag.a Dr.in Verena Plattner
AGES
stv. Mitglied
Blood Products Working Party
BPWP
F
Dr.in Brigitte Müller
AGES
Mitglied
BPWP
F
Mag.a Daniela Philadelphy
AGES
Mitglied
CHMP Biologics Working Party
BWP
F
Dr.in Ilona Reischl
AGES
Mitglied
BWP
F
Mag. Christian Mayer
AGES
stv. Mitglied
CHMP Biostatistics Working Party
BSWP
F
Mag. Christian Gartner
AGES
Mitglied
BSWP
F
Mag. Thomas Lang
AGES
Mitglied
CHMP BWP ad hoc Influenza WP
CHMP BWP ad hoc Influenza WP
F
Mag.a Petra Falb
AGES
Mitglied
CHMP BWP Plasma Master File Drafting Group
CHMP BWP Plasma Master File Drafting Group
F
Dr.in Martina Joseph
AGES
Mitglied
CHMP Pharmacokinetic WP
PKWP
F
Dr. Jan Neuhauser
AGES
Mitglied
PKWP
F
Mag.a Karin Kundler
AGES
Beobachter
CHMP Safety Working Party
SWP‐H
F
Dr. DI, MDRA Günter Waxenecker
AGES
Mitglied
SWP‐H
F
Mag.a Dr.in Klaudia Hettinger
AGES
stv. Mitglied
CHMP Scientific Advice WP
SAWP
F
Mag. Thomas Lang
AGES
Mitglied
Gültig ab: 03.06.2016
Seite 3/10
(deutsch)
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
AGES representative
Funktion /
function
SAWP
F
AGES
Mitglied
SAWP
F
AGES
stv. Mitglied
SAWP
F
AGES
Mitglied
SAWP
F
Dr. Andreas Kirisits, MSc
AGES
stv. Mitglied
CHMP Vaccine Working Party (VWP)
CHMP Vaccine Working Party (VWP)
VWP
F
Dr.in Petra Schlick
AGES
Mitglied
CHMP/CVMP QWP core team
CHMP/CVMP QWP core team
F
DI in Susanne Stotter
AGES
Mitglied
CHMP/CVMP: Quality Working Party
CHMP/CVMP Quality Working Party
F
AGES
Mitglied
CHMP‐Associated QRD
CHMP‐Associated QRD
F
Dr.in Petra Wiesinger
AGES
Mitglied
Consultative Group on Veterinary
Pharmacovigilance Systems
Consultative Group on Veterinary
Pharmacovigilance Systems
CGVPhS
F
Mag.a vet.med. Brigitte Hauser
AGES
Experte/in
CVMP Efficacy Working Party
CVMP Efficacy Working Party
EWP‐V
F
Dr.in Anja Kotschwar
AGES
Mitglied
CVMP Immunologicals Working Party
CVMP Immunologicals Working Party
F
Mag.a Petra Falb
AGES
Mitglied
CVMP Safety Working Party
CVMP Safety Working Party
F
AGES
Mitglied
EMA Innovation Network
EMA Innovation Network
I
Dr.in Ilona Reischl
AGES
Mitglied
I
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 IWG
F
DI Matthias Loibl
AGES
Mitglied
GCP IWG
F
Dr.in Ilona Reischl
AGES
stv. Mitglied
GMDP Inspectors Working Group
GMDP Inspectors Working Group
GMDP IWG
F
AGES
Mitglied
Guideline Consistency Group
Guideline Consistency Group
F
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
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
EMA Pandemic Influenza Crisis Management Plan
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
AGES
Mitglied
Pandemic task force
Pandemic task force
ETF
I
AGES
Mitglied
Pharmacovigilance Working Party (veterinary)
Pharmacovigilance Working Party (veterinary)
PhVWP‐V
F
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
AGES
Mitglied
EMA Kontaktstellen / contact points
Contact point for PMF Baxter
Contact point for PMF Baxter
I
AGES
Kontaktstelle
EMA National contact point for referrals
I
Mag. Rudolf Schranz
AGES
Kontaktstelle
I
Mag.a pharm. Dr.in rer. nat. Ulrike Rehberger AGES
Kontaktstelle
I
Ing.in Veronika Iro
AGES
Kontaktstelle
EMA PMF Coordinator
PMF Coordinator
F
Dr.in Ilona Reischl
AGES
Kontaktstelle
European Experts Database Contact Point
I
Denise Hörmann
AGES
Kontaktstelle
I
Stefanie Rauscher
AGES
Kontaktstelle
Name Review Group (NRG)
Name Review Group (NRG)
NRG
I
Dr.in Mag.a Ursula Ladstädter
AGES
Mitglied
Name Review Group (NRG) Contact Point
NRG
I
AGES
Kontaktstelle
NRG
I
Mag.a Rosemarie Potisk
AGES
Kontaktstelle
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
EMA Expert
EMA Expert
EMA Expert
I
Dr.René Anour
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
DI Julia‐Verena Bacher
AGES
Experte/in
Gültig ab: 03.06.2016
Seite 4/10
(deutsch)
(English)
Akronym /
Abbrev.
Institution /
custodian
organisation
AGES representative
Funktion /
function
EMA Expert
EMA Expert
EMA Expert
I
Dr. DI Ronald Bauer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr. Gerhard Beck
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr. Mahdi Ben Cheikh
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Viviane Benetka
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Isabella Berger
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag. Richard Cejka‐Scheidl
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Dominika Chrusciel
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Christinane Cserveny, BSc, BVSc, MRCVS
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Zehra Dzanic
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Sonja Ernsthofer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Petra Falb
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Gabriela Fischer‐Mayer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Beate Gasser
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Ingeborg Gerngross
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Petra Günter‐Stadlmaier
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Katharina Hausteiner‐Melichar
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Ulrike Heissenberger
AGES
stv. Mitglied
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Irmtraud Held
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
DIDr. Wolfgang Herzog
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
stv. Mitglied
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Mirjam Hinterleitner
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag. Gernot Hirn
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Simone Hofbauer
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Claudia Baranyi
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr.in Sonja Hrabcik
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
AGES
Kontaktstelle
EMA Expert
EMA Expert
EMA Expert
I
Dr. Jan Joseph
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
DI (FH) Christoph Kefeder, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Dr. Andreas Kirisits, MSc
AGES
Experte/in
EMA Expert
EMA Expert
EMA Expert
I
Mag.a Caroline Kleber
AGES
Experte/in
EMA Expert
EMA Expert
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Dr. Alexander Knieps
AGES
Experte/in
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Mag.a Sabine Koper
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Dr.in Anja Kotschwar
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AGES
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EMA Expert
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EMA Expert
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Mag. Thomas Lang
AGES
Experte/in
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Dr. Stephan Lehr
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Dr.in Manuela Leitner
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Mag.a Ines Lindner
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DI, Matthias Loibl
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Dr.in Marianne Lunzer
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Dr.in Beate Maichel
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Mag.a Dr.in Christine Meissner
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Dr.in Ulrike Michel
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Dr. Leonhard‐Key Mien
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Dr.in Ramona Mirzaei
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Dr.in Manuela Mondl
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Dr. Jan Neuhauser
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Mag.a Daniela Philadelphy
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DI (FH) Patrick Pichler
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Mag.a Dr.in Verena Plattner
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Mag.a Karin Pöllitzer
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Mag.a Rosemarie Potisk
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Mag.a Dr.in Verena Pötsch
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Dr.in Claudia Pramesberger, MSc
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Dr.in Claudia Preßl
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Dr. Dieter Pullirsch
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Dr. Florian Rauchensteiner
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Mag.a Sofie Regner
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Dr.in Ulrike Rehberger
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Dr.in Martina Reichelt
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Mag. Roland Reimann
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Dr.in Birgit Reinprecht
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Mag. Dr. Olga Rögelsperger
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Dr.in Lisa Rosner
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Dr.in Gabriele Rothmüller
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DI Heidemarie Schindl
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Mag.a Katrin Schlager, MSc
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Dr.in Petra Schlick
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EMA Expert
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Mag. Rudolf Schranz
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Experte/in
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Mag.a Iria Schubert
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Dr.in Alexandra Seifner
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DIin Dr.in Doris Sommer
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Dr.in Corina Spreitzer
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Dr. Martin Spruth
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Dr.in Milena Stain
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Dr. Stefan Strasser
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DI Klaus Stüwe
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Mag.a Brigitte Tarasiewicz
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Dr.in Martine Trauffler
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Mag.a Yu‐ting Tseng
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Mag.a Dr.in Christine Vaculik
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Dr. Thomas Wächter
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Mag.a Katharina Weber
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Dr.in Johanna Wernsperger
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Dr.in Petra Wiesinger
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Dr.in Daniela Wöhrer
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Dr.in Susanne Wolf, MPH
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Ing. Ingrid Zlabinger, BSc
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DI, Michael Zwitkovits, MSc
AGES
Experte/in
CO‐Rapporteur Celvapan
CO‐Rapporteur Celvapan
I
AGES
Experte/in
Assessor for the evaluation of a pandemic
influenza vaccine
influenza vaccine
I
Mag.a Petra Falb
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Experte/in
influenza vaccine
influenza vaccine
I
Mag. Thomas Lang
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Experte/in
influenza vaccine
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I
AGES
Experte/in
influenza vaccine
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I
AGES
Experte/in
Gemeinsame Arbeitsgruppen EMA/HMA / joint committees and working groups EMA/HMA
Common European Submission Plattform
Common European Submission Plattform
CESP
F
EU Telematics programme
DI Georg Neuwirther
AGES
Mitglied
eCTD Maintenance Group
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F
DI Georg Neuwirther
AGES
Mitglied
electronic Application Form Maintenance Group
electronic Application Form Maintenance Group
eAF MG
F
DI Georg Neuwirther
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Mitglied
eSubmission Change Management Board
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eSubmission
CMB
F
DI Georg Neuwirther
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Mitglied
EU Network Training Center
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F
HMA Mandat
AGES
Vorsitz
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Eudra GMP IT‐Subgroup
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EU NTC
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Funktion /
function
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HMA Mandat
AGES
Mitglied
Eudra GMP IT‐Subgroup
F
Mag.a Karin Pöllitzer
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Mitglied
EudraCT DWH Subgroup & Power User
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F
Dr. Stefan Strasser
AGES
Mitglied
EudraVigilance Telematic Implementation Group
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EV TIG
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Mag. Rudolf Schranz
AGES
Mitglied
EUTCT Full Group
European Union Telematics Controlled Terms
(EUTCT) Full Group
EUTCT FG
F
AGES
Mitglied
EUTCT Full Group
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(EUTCT) Full Group
EUTCT FG
F
AGES
stv. Mitglied
IT‐Directors Group
IT‐Directors Group
F
DI Georg Neuwirther
AGES
Mitglied
Telematics Enterprise Architecture Board
Telematics Enterprise Architecture Board
TEAB
F
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
(BEMA) Assessor
BEMA
I
HMA Mandat
DI Klaus Stüwe
AGES
Experte/in
(BEMA) Steering Group
(BEMA) Steering Group
BEMA SG
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Clinical Trials Facilitation Group
CTFG
F
HMA Mandat
Dr.in Corina Spreitzer
AGES
stv. Mitglied
CTFG
F
HMA Mandat
Dr. Stefan Strasser
AGES
MItglied
European Medicines Agencies Co‐operation on
Legal and Legislative Issues
EMACOLEX
F
HMA Mandat
AGES
Mitglied
EMACOLEX
F
HMA Mandat
AGES
stv. Mitglied
I
HMA Mandat
AGES
Mitglied
Expert Group of Pharmaceutical Quality Assessors Expert Group of Pharmaceutical Quality Assessors
GCP Inspectors Working Group/CMDh Working
Party
Party
GCP IWG/CMD F
HMA Mandat
Dr.in Isabella Berger
AGES
Mitglied
Party
Party
GCP IWG/CMD F
HMA Mandat
AGES
Mitglied
Heads of national Agencies
Heads of national Agencies
HMA
F
HMA Mandat
AGES
Mitglied
HMA Task Force FMD
HMA TF Falsified Medicines Directive
F
HMA Mandat
AGES
Mitglied
HMA Working Group of Communication
Professionals
HMA Working Group of Communication
Professionals
F
HMA Mandat
AGES
Mitglied
Homoepathic Medicinal Products Working Group
HMPWG
F
HMA Mandat
AGES
stv. Mitglied
HMPWG
F
HMA Mandat
AGES
Mitglied
HMA Mandat
Mag.a Caroline Kleber
AGES
Experte/in
HMA Mandat
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
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Pharmacovigilance Audit Facilitation Group
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PAFG
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Working Group of Enforcement Officers
Working Group of Enforcement Officers
WGEO
F
HMA Mandat
AGES
Mitglied
Working Group of Quality Managers
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WGQM
F
HMA Mandat
DI Klaus Stüwe
AGES
Mitglied
Council of Europe Resolution AP‐CSP (07) 1
Übereinkommen über die Ausarbeitung eines
europäischen Arzneibuches
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
AGES
Mitglied
I
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
Mag. Josef Trenker
AGES
stv. Mitglied
F
AGES
Mitglied
AGES
Mitglied
Homoeopathic Manufacturing Methods Group
Homoeopathic Manufacturing Methods Group
HMM
Ph. Eur. Expert group 12
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Group 12
F
Ph. Eur. Expert Group 15 (Vakzine)
Ph. Eur. Expert Group 15 (Vaccines)
Group 15
F
AGES
Mitglied
F
AGES
Mitglied
F
AGES
Mitglied
F
AGES
Mitglied
Ph. Eur. Expert Group 15 (veterinär‐Vakzine)
EDQM WG "Traditional Chinese Medicines"
EDQM MQH
Ph. Eur. Expert Group 15 (veterinary vaccines)
Ph. Eur. Expert Group 6B
Ph. Eur. Expert Group 6B
Ph. Eur. Expert Group Allergen Products
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Group 15V
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Ph. Eur. Expert Group Gene Therapy Products
(English)
Akronym /
Abbrev.
Ph. Eur. Expert Group Gene Therapy Products
Institution /
custodian
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AGES representative
Funktion /
function
F
AGES
Mitglied
AGES
Mitglied
Ph. Eur. Expert Group Monoclonal Antibodies
Ph. Eur. Expert Group Monoclonal Antibodies
MAB
F
Ph. Eur. Working Party P4 biologicals
Ph. Eur. Working Party P4 biologicals
P4Bio
F
AGES
Mitglied
EDQM Ad hoc committee
AHC
I
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
AGES
Experte/in
I
AGES
Experte/in
I
Dr. Jan Joseph
AGES
Experte/in
I
Dr. Alexander Knieps
AGES
Experte/in
I
Dr.in Manuela Leitner
AGES
Experte/in
I
Dr.in Beate Maichel
AGES
Experte/in
I
Dr. Florian Rauchensteiner
AGES
Experte/in
I
Mag. Roland Reimann
AGES
Experte/in
I
DIin Dr.in Doris Sommer
AGES
Experte/in
I
Mag.a Yu‐ting Tseng
AGES
Experte/in
National contact point for CEP
I
AGES
Kontaktstelle
I
AGES
Kontaktstelle
I
AGES
Kontaktstelle
I
Mag.a Martina Unteregger
AGES
Kontaktstelle
I
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
DI Klaus Stüwe
AGES
Experte/in
Counterfeit/Illegal Medicines WG
Counterfeit/Illegal Medicines WG
F
Dr. Andreas Hackl
AGES
Mitglied
Gene Therapy Products (GTP) Working Group
Gene Therapy Products (GTP) Working Group
F
AGES
Mitglied
OMCL Communication Group
OMCL Communication Group
F
DI Thomas Lang
AGES
Mitglied
OMCL Contact für Probennahme zentral
zugelassener Asp
OMCL Contact CAP sampling
I
DI Reinhard Stark
AGES
Kontaktstelle
OMCL Contact OCABR Blutprodukte
OMCL Contact OCABR blood derivatives
I
AGES
Kontaktstelle
OMCL Contact OCABR Impfstoffe
OMCL Contact OCABR vaccines
I
AGES
Kontaktstelle
OMCL Kontakt CAP‐Testing und Contracting
(Hum./Biol. und Vet./Biol.)
OMCL Contact for CAP Testing (Hum/Biol. and
vet/Biol.)
I
AGES
Kontaktstelle
OMCL Kontakt CAP‐Testing und Contracting
(Hum./Chem. und Vet./Chem.)
OMCL Contact for CAP Testing (Hum/Chem. and
vet/Chem.)
I
DI Thomas Lang
AGES
Kontaktstelle
OMCL Kontakt MRP/DCP‐Testing
OMCL Contact for MRP/DCP Testing
I
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
AGES
Mitglied
Standard Terms Working Party
Standard Terms Working Party
ST WP
AGES
Mitglied
Dr. Reinhard Berger
AGES
Mitglied
AGES
Kontaktstelle
F
andere europäische Gremien / other European committees and working groups
Deutsche Arbeitsgemeinschaft Medizinprodukte
European Haemovigilance Network
European Haemovigilance Network
AGMP
I
EHN
F
Zusammenarbeit der deutschsprachigen
Marktüberwachungsbehörden
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Seite 9/10
(deutsch)
(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
Verordnung (EG) Nr. 178/2002
AGES representative
Funktion /
function
AGES
Experte/in
AGES
stv. Mitglied
AB‐Gesetz
Mag. Josef Trenker
AGES
Mitglied
Verordnung (EG) Nr. 178/2002
AGES
Mitglied
internationale Gremien / international committees and working groups
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
Seite 10/10

L A50 Gremien MEA

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