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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at
Austrian Medicines & Medical Devices Agency
MEA Infoveranstaltung 15. 9.2014 DI Dr. Christa Wirthumer-Hoche
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AGES-Struktur (Stand: 01.07.2014)
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Austrian Agency for Health and Food Safety
Wolfgang Hermann
Austrian Medicines and Medical Devices Agency (MEA)
Christa Wirthumer-Hoche
Business Development (GFEV)
Arnold Herzog
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
Institute Assessment & Analytics (BGA)
Gerhard Beck
Institute Surveillance (INS)
Ronald Bauer
Regulatory Affairs (REGA)
Alexander Ertl
Medical Assessment (MRAT)
Ingeborg Gerngroß
Quality Assessment Medicinal Products (QUAL)
Susanne Stotter
Analytics Biological Medicinal Products (BAMA)
Heidemarie Schindl
Analytics Chemical-pharmaceutical Medicinal Products (CPAA)
Roman Macas
Clinical Assessment of Safety & Efficacy (CASE)
Barbara Tucek
Biologicals, Preclinical & Statistical Assessment, Veterinary Medicinal Products (BPSV)
Barbara Zemann
Good Manufacturing Practice (GMDP)
Andreas Kraßnigg
Clinical Trials (CLTR)
Ilona Reischl
Medical Devices Market Surveillance (MDVI)
Reinhard Berger
Blood, Tissue & Vigilance (BTVI)
Waltraud Trabe
AUSTRIAN FEDERAL OFFICE FOR SAFETY
IN HEALTH CARE
Quality Management (QMGT)
Klaus Stüwe
Scientific Office (SCIO)
Andrea Laslop
L_MEA_SGB_00QM_A04_16 Gültig ab: 27.08.2014
Assessment Pharmacovigilance (APHV)
Barbara Tucek
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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
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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)
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Strengthen Communication
Proactive exchange of information between stakeholder and the Austrian Agency
Individual stakeholder meetings
Stakeholder engagement
Case mangement for important EU processes
Systematic analysis of the Pharma-market
AGES Medicines &
Medical Devices Agency
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Processes of the Austrian Medicines and Medical Devices Agency in the Life-Cycle of Medicinal Products
! AGES-MEA
Scientific / Regulatory Advice
Assessment of Clinical Trials
GLP- & GCP-Inspections
Manufacturing Authorisation
(GMP-Inspections) Marketing
Authorisation
Safety Signals & Risk Management
periodic GMP-Inspections
Market Surveillance
Official Control Authority Batch Release
Variations / Renewals of Marketing Authorisation
Variations of Manufacturing Authorisation
Suspension of Marketing
Authorisation
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Sustainment of the position in the EU-network
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Austrian Medicine & Medical Devices Agency
Thomas Reichhart Austrian Federal Office for Safety in Healtcare
Andrea Laslop Scientific Office
Klaus Stüwe Quality Management
Arnold Herzog Business
Developement
Christa Wirthumer-Hoche Head of Agency
Christoph Baumgärtel Communication
Georg Neuwirther IT Services
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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
AGES provides the federal office with the means required to carry out their tasks (§§ 6 and 6a GESG).
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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)
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• 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.
Strategic perspectives 2015 - 2017
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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
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Contacts
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Thank you for your attention!
Any questions?