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Austrian Medicines & Medical
Devices Agency
MEA Infoveranstaltung 15. 9.2014
DI Dr. Christa Wirthumer-Hoche
www.ages.at
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
AGES-Struktur
www.ages.at
(Stand: 01.07.2014)
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Austrian Agency for Health and Food Safety
Wolfgang Hermann
AUSTRIAN FEDERAL
OFFICE FOR SAFETY
IN HEALTH CARE
Austrian Medicines and Medical Devices Agency (MEA)
Christa Wirthumer-Hoche
Bureau of the Austrian Federal Office for Safety in
Health Care (BBSG)
Thomas Reichhart
Institute Marketing Authorisation of Medicinal Products & Lifecycle
Management (LCM)
Peter Platzer
Scientific Office (SCIO)
Quality Management (QMGT)
Business Development (GFEV)
Andrea Laslop
Klaus Stüwe
Arnold Herzog
Institute Assessment & Analytics (BGA)
Institute Surveillance (INS)
Gerhard Beck
Ronald Bauer
Regulatory Affairs (REGA)
Analytics Biological Medicinal Products (BAMA)
Good Manufacturing Practice (GMDP)
Alexander Ertl
Heidemarie Schindl
Andreas Kraßnigg
Medical Assessment (MRAT)
Analytics Chemical-pharmaceutical Medicinal
Products (CPAA)
Clinical Trials (CLTR)
Ingeborg Gerngroß
Roman Macas
Ilona Reischl
Quality Assessment Medicinal Products (QUAL)
Clinical Assessment of Safety & Efficacy (CASE)
Medical Devices Market Surveillance (MDVI)
Susanne Stotter
Barbara Tucek
Reinhard Berger
Biologicals, Preclinical & Statistical Assessment,
Veterinary Medicinal Products (BPSV)
Blood, Tissue & Vigilance (BTVI)
Barbara Zemann
Assessment Pharmacovigilance (APHV)
www.ages.at
L_MEA_SGB_00QM_A04_16
Barbara Tucek
Gültig ab: 27.08.2014
Waltraud Trabe
AGES-MEA: goals for 2014
• MEA-Stability
- Staff – motivation of colleagues
- Organisation - optimisation of the new structure
- Financial - increasing demand
• Strengthen communication with stakeholder
- Presentations „pipeline meetings“
- Information (RMS-letter in EN)
• Further increase in efficiency & effectiveness of our
procedures
• BASG Website (www.basg.gv.at):
- Extension of the EN part
www.ages.at
AGES-MEA
• Currently 3 sites
- 1200 Wien, Traisengasse 5
- OMCL-chem.pharm, 1090 Zimmermanng.
- OMCL-biological, 1160 Possingergasse
• Employees
- ~about 260 FTE (full time equivalent)
www.ages.at
Strengthen Communication
Proactive exchange of information between
stakeholder and the Austrian Agency
AGES
Medicines &
Medical
Devices
Agency
Individual stakeholder meetings
Stakeholder engagement
Case mangement for important EU processes
Systematic analysis of the Pharma-market
www.ages.at
Processes of the Austrian
Medicines and Medical Devices Agency
in the Life-Cycle of Medicinal Products
Scientific /
Regulatory Advice
!
www.ages.at
Assessment of
Clinical Trials
GLP- & GCP-Inspections
Marketing
Authorisation
Safety Signals &
Risk Management
AGES-MEA
Suspension of
Marketing
Authorisation
Manufacturing
Authorisation
(GMP-Inspections)
Variations / Renewals of
Marketing Authorisation
Variations of Manufacturing
Authorisation
periodic GMP-Inspections
Market Surveillance
Official Control Authority
Batch Release
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Sustainment of the position in the
EU-network
120
100
80
60
40
20
0
www.ages.at
MRP
DCP
NLDE
UK
DKPTSEATCZESHUFIFREEIEIS
MT
BEITLV
NO
HRSISKBG
CYELLILTLUPL
Austrian Medicine &
Medical Devices Agency
Thomas Reichhart
Austrian Federal Office
for Safety in Healtcare
Andrea Laslop
Scientific Office
Christa Wirthumer-Hoche
Head of Agency
Arnold Herzog
Klaus Stüwe
Business
Developement
Quality Management
Christoph Baumgärtel Georg Neuwirther
Communication
www.ages.at
IT Services
BASG - Federal Office for Safety in
Health Care
Authority directly subordinate to the Federal Minister of Health
Put into effect the following special administrative laws:
• Medicines Act
• Medicinal Products Import Act
• Blood Safety Act
• Medical Devices Act
• Compulsory Prescription Act
• Tissue Safety Act
• Inspections according to the
Addictive Drug Act
[email protected]
AGES provides the federal office with the means required to carry out their tasks (§§ 6 and 6a GESG).
www.ages.at
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Strategic perspectives 2015 - 2017
• Active involvement in EU regulatory procedures
• Vision „Top 5“
• Sustainment of active communication and information
of our stakeholder
- Website in DE & EN (www.ages.at, www.basg.gv.at)
- Pipelinemeetings, ….
- Newsletter
• Electronic submission
- From paper world to electronic world
o AGES
Gespräch „e-submission“ – Sept 9th, 2014
o E-submission roadmap (EU)
o Electronic submission regulation (AT)
www.ages.at
Strategic perspectives 2015 - 2017
• Implementation of new legal provisions
- Clinical Trial Regulation
o Dialogtag
mit Ethikkommissionen, Oct 8th 2014, by invitation only
o AGES-Gespräch – Clinical Trials, Nov. 25th, 2014
- Falsified Medicinal Products Directive (2011/62/EU)
o Safety
feature
o Black & white list
o Online sale of medicine
 Register for internet pharmacies
• Revision of the AT fee regulation
• OMCL
- In-vitro monograph for FSME batch release
- Move of OMCL-chem.pharm. to Spargelfeldstr.
www.ages.at
Contacts
• Inquires for Marketing Authorisations: [email protected]
• Inquires for Marketing Authorisations and Lifecycle Management:
[email protected]
• Inquires for Surveillance: [email protected]
• Inquires for Scientific-Advice: [email protected]
• All other inquires: [email protected]
Further information: http://www.basg.gv.at
and http://www.ages.at
www.ages.at
Contacts
www.ages.at
Thank you for your attention!
Any questions?
www.ages.at

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