Austrian Medicines & Medical Devices Agency

Transcription

1 Austrian Medicines & Medical Devices Agency MEA Infoveranstaltung DI Dr. Christa Wirthumer-Hoche Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

2 AGES-Struktur (Stand: ) 2

3 Austrian Agency for Health and Food Safety AUSTRIAN FEDERAL OFFICE FOR SAFETY IN HEALTH CARE Wolfgang Hermann Austrian Medicines and Medical Devices Agency (MEA) Christa Wirthumer-Hoche Bureau of the Austrian Federal Office for Safety in Health Care (BBSG) Scientific Office (SCIO) Quality Management (QMGT) Business Development (GFEV) Thomas Reichhart Andrea Laslop Klaus Stüwe Arnold Herzog Institute Marketing Authorisation of Medicinal Products & Lifecycle Management (LCM) Institute Assessment & Analytics (BGA) Institute Surveillance (INS) Peter Platzer 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 Waltraud Trabe Assessment Pharmacovigilance (APHV) Barbara Tucek L_MEA_SGB_00QM_A04_16 Gültig ab:

4 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 ( - Extension of the EN part

5 AGES-MEA Currently 3 sites Wien, Traisengasse 5 - OMCL-chem.pharm, 1090 Zimmermanng. - OMCL-biological, 1160 Possingergasse Employees - ~about 260 FTE (full time equivalent)

6 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

7 Processes of the Austrian Medicines and Medical Devices Agency in the Life-Cycle of Medicinal Products Suspension of Marketing Authorisation Scientific / Regulatory Advice! AGES-MEA Manufacturing Authorisation (GMP-Inspections) Variations / Renewals of Marketing Authorisation Variations of Manufacturing Authorisation Assessment of Clinical Trials GLP- & GCP-Inspections Safety Signals & Risk Management Marketing Authorisation periodic GMP-Inspections Market Surveillance Official Control Authority Batch Release 7

8 Sustainment of the position in the EU-network NLDEUKDKPTSEATCZESHUFIFREEIEISMTBEITLVNOHRSISKBGCYELLILTLUPL MRP DCP

9 Austrian Medicine & Medical Devices Agency Andrea Laslop Scientific Office Thomas Reichhart Austrian Federal Office for Safety in Healtcare Christa Wirthumer-Hoche Head of Agency Klaus Stüwe Quality Management Arnold Herzog Business Developement Christoph Baumgärtel Communication Georg Neuwirther IT Services

10 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 basg@basg.at AGES provides the federal office with the means required to carry out their tasks ( 6 and 6a GESG). 10

11 Strategic perspectives Active involvement in EU regulatory procedures Vision Top 5 Sustainment of active communication and information of our stakeholder - Website in DE & EN (, - 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)

12 Strategic perspectives 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, 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.

13 Contacts Inquires for Marketing Authorisations: Inquires for Marketing Authorisations and Lifecycle Management: Inquires for Surveillance: Inquires for Scientific-Advice: All other inquires: Further information: and

14 Contacts

15 Thank you for your attention! Any questions?