Austrian Medicines & Medical Devices Agency Role in Centralised Procedures
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1 Austrian Medicines & Medical Devices Agency Role in Centralised Procedures Gerhard Beck Head of Institute Assessment & Analytics Austrian Federal Office for Safety in Health Care
2 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) Thomas Reichhart Scientific Office (SCIO) Andrea Laslop Quality Management (QMGT) Klaus Stüwe Business Development (GFEV) Arnold Herzog Institute Marketing Authorisation of Medicinal Products & Lifecycle Management (LCM) Peter Platzer Regulatory Affairs (REGA) Alexander Ertl Medical Assessment (MRAT) Ingeborg Gerngroß Quality Assessment Medicinal Products (QUAL) Susanne Stotter Herbal, Homeopathic & Veterinary Medicinal Products (HEVE) Reinhard Länger Institute Assessment & Analytics (BGA) Gerhard Beck Analytics of Biological Medicinal Products (BAMA) Heidemarie Schindl Analytics of Chemicalpharmaceutical Medicinal Products (CPAA) Roman Macas Clinical Assessment of Safety & Efficacy (CASE) Barbara Tucek Biologicals, Preclinical & Statistical Assessment (BPSA) Barbara Zemann Assessment Pharmacovigilance (APHV) Barbara Tucek Institute Surveillance (INS) Ronald Bauer Good Manufacturing Practice (GMDP) Andreas Kraßnigg Clinical Trials (CLTR) Ilona Reischl Medical Devices Market Surveillance (MDVI) Andreas Amon Blood, Tissue & Vigilance (BTVI) Verena Plattner L_MEA_SGB_00QM_A04_23 valid from:
3 EMA Scientific Office Assessment & Analytics G. Beck EDQM A s s e s s m e n t CASE Clinical Assessment of Safety & Efficacy B. Tucek BPSA Biologicals, Preclinical.& Statistical Assessment B. Zemann APHV Assessment Pharmacovigilance B. Tucek BAMA Analytics of Biological Medicinal Products H. Schindl CPAA Analytics of Chemical-pharmaceutical Medicinal Products R. Macas O M C L 1200 Traisengasse 1160 Possingergasse 1220 Spargelfeldstr. 3
4 Premises of AGES MEA Assessment Bio-OMCL Chem-OMCL AGES MEA Traisengasse Vienna Tel: +43 (0) AGES MEA Possingergasse Vienna Tel: +43 (0) AGES MEA Spargelfeldstrasse Vienna Tel: +43 (0)
5 Assessment -> our main tasks Centralised Procedures (CHMP) (MRP/DCP/national procedures for biologicals and/or new chemical substances) Scientific Advice EMA: SAWP, national Sc. Ad. Pharmacovigilance Procedures (PRAC) Representatives in EMA committees/working parties CHMP, CVMP, PDCO,COMP, CAT, BWP, QWP,BPWP, VWP, BSWP, SWP,.. Representatives in Pharm. Europ. Expert. Groups Pharm Eur. Commission, Group 6B, 10, 15, 15V.. 5
6 Assessment: indications & main focus of expertise Plasma derived medicinal products Recombinant coagulation factors Vaccines Osteoporosis/bone-metabolism Rheumatology Ophthalmological products Biosimilars Generics New: Haemato-Oncology 6
7 APHV: Assessment Pharmacovigilance 13 Assessors 2 Administrators Risk Management Plans (RMP) Post Authorisation Safety Studies (PASS) Referrals Safety-driven Variations Urgent Safety Restrictions (USR) Periodic Safety Update Reports (PSUR) PSUR Single Assessment (PSUSA) Periodic Benefit-Risk Evaluation Report (PBRER) 7
8 BPSA: Biologics-, Preclinical- Statistical- Assessment 16 Assessors 1 Administrator Assessment of Bio-Quality (Biologics), Preclinial and Statistical Data for all type of procedures (application for marketing authorisation, variations, renewals, referrals, re-examinations, scientific advice) Overall Benefit Risk Assessment 8
9 CASE: Assessment Safety & Efficacy 17 Assessors 3 Administrators Assessment of clinical data in all type of procedures (application for marketing authorisation, variations, renewals, referrals, re-examinations, scientific advice) Overall Benefit/Risk Assessment 9
10 QUAL: Quality Assessment Medicinal Products QUAL is part of Institute Life Cylcle Management Assessor on demand Assessment of quality data of chemimcal-pharmaceuticlal Medicinal Products for all type of procedures (application for marketing authorisation, variations, renewals, referrals, re-examinations, scientific advice) Overall Benefit/Risk Assessment 10
11 Thank you 11
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