Austrian Agency for Health and Food Safety www.ages.at

Institute Assessment & Analytics (BGA)

Dr. Gerhard Beck BGA AGES Medizinmarktaufsicht – Erfahrung mit der neuen Struktur Wien, 15. Sept. 2014

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Assessment & Analytics

G. Beck

CPAA Analytics of

Chemical-pharmaceutical Medicinal Products

R. Macas

BAMA Analytics of Biological

Medicinal Products H. Schindl

APHV Assessment

Pharmacovigilance B. Tucek

1200 Traisengasse

1160 Possingergasse 1090 Zimmermanng.

CASE Clinical Assessment of

Safety & Efficacy B. Tucek

BPSV Biologicals, Preclinical & Statistical Assessment,

Veterinary Medicinal Products B. Zemann

Assessment

OMCL

EMA EDQM

Consultants: Friedrich Lackner

Andreas Mayrhofer

Duties and responsibilities

•Assessment: applications for: marketing authorisation, variation, renewal, re-examination, referral -> Centralised procedure: biological, chemical & herbal medicinal products -> MRP/DCP and national procedure: biological & herbal medicinal products -> Pharmacovigilance procedures -> Scientific Advice EMA and National

• OMCL: ->Marketing surveillance (quality control) of medicinal products (legal & illegal market)

->Official control authority batch release 3

Head of department: Barbara Tucek (Jan Neuhauser)

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Department Clinical Assessment of Safety & Efficacy (CASE)

Scientific Advice René Anour

(Andreas Kirisits)

Biologika Brigitte Müller

(Daniela Philadelphy)

René Anour, Mahdi Ben-Cheikh, Dominika Chrusciel, Christiane Cserveny, Zehra Dzanic, Katharina Hausteiner-Melichar, Samantha Hewavitharana, Mirjam

Hinterleitner, Christina Kerscher, Andreas Kirisits, Lisa Koinig, Ulrike Michel, Brigitte Müller, Jan Neuhauser, Daniela Philadelphy,

Iria Schubert, Barbara Szivacz, Johanna Wernsperger, Daniela Wöhrer, Tanja Zahlner, Elvira Zimre-Grabensteiner

HERB (LCM/QUAL: Länger)

CP Admin Team Stefan Fringer, Tanja Knapp, Sylvia Pach

CP chem, biosim Jan Neuhauser

(Christina Kerscher)

Beatrix Cihal, Regina Mekonnen,

Brigitta Sabor

Duties and responsibilities

•CP Chemical-, biological-, herbal human medicinal products

Clinical assessment Applications for marketing authorisation, variations, renewals, referrals, re-examinations

•National, MRP/DCP Biological-, herbal human MPs Clinical assessment Applications for marketing authorisation, variations, renewals, referrals

•Scientific advice NASA Nationaler Scientific Advice EMA EMA-Scientific Advice

Contact (NASA): scientificadvice@ages.at

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Working Parties & Committees

• Blood Products Working Party (BPWP) European Pandemic Task Force (ETF) Brigitte Müller

• Pharmacokinetic Working Party (PKWP) Jan Neuhauser

• National Vaccination Committee („Nationales Impfgremium“ - NIG), National Pandemic Task Force Barbara Tucek

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Department Assessment-Pharmacovigilance (APHV)

Marianne Lunzer, Ramona Mirzaei, Leonhard-Key Mien, Manuela Mondl,

Claudia Reichelt, Irmgard Resch, Katja Valent, Susanne Wolf

Assessment - Pharmacovigilance Expert Group Coordinator

Sonja Hrabcik (Susanne Wolf)

Contact: CASE_PHV@ages.at

Head of department: Barbara Tucek (Jan Neuhauser)

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Duties and responsibilities

•National procedures, MRP/DCP, CP Risk Management Plans (RMP) Post Authorisation Safety Studies (PASS) Referrals Safety-driven Variations Urgent Safety Restrictions (USR) Re-examinations Periodic Safety Update Reports (PSUR) PSUR Single Assessment (PSUSA) Periodic Benefit-Risk Evaluation Report (PBRER)

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Working Parties & Committees

•Pharmacovigilance Risk Assessment Committee PRAC until 31.05.2015 Harald Herkner /MedUni Wien alternate: Jan Neuhauser after 01.06.2015 Jan Neuhauser alternate: Marianne Lunzer •PSUR Worksharing Working Party Irmgard Resch

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Head of department: Barbara Zemann (Ulrike Heißenberger)

Support: Daniela Gutschi

Group Biologicals

Ulrike Heissenberger (deputy head of dpt) Christian Mayer • Petra Falb • Irmtraud Held • Martina Joseph • Manuela Leitner • Petra Schlick

Preclincal assessment

Günter Waxenecker • Klaudia Hettinger

Group Statistics

Thomas Lang • Christian Gartner

Group Veterinary Medicinal Products

Eugen Obermayr • Brigitte Hauser • Anja Kotschwar • Ingrid Langner • Ines Lindner • Gabriele Rothmüller • (Petra Günter-

Stadlmaier)

Biologicals, Preclinical & Statistical Assessment, Veterinary Medicinal Products (BPSV)

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Duties and responsibilities

•Assessment veterinary medicinal products Bio-quality, preclinical, clinical, statistical and pharmacovigilance data

•Assessment human medicinal products Bio-quality, preclinical and statistical data Support of the Clinical Trials Department

•Scientific Advice EMA & National Scientific Advice

•ESVAC Surveillance of Veterinary Antimicrobial Consumption

• PHV (v)

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Working Parties & Committees

• Committee for Medicinal Products for Veterinary Use Barbara Zemann

• Safety Working Party Günter Waxenecker (h)/Barbara Zemann (v)

• Scientific Advice Working Party Biostatistics Working Party (Vice Chair) Thomas Lang

• Pharmacovigilance Working Party-V (veterinary) Brigitte Hauser

• Nationales Impfgremium & Pandemic Task Force, Ad-hoc Influenca Working Party Petra Falb

• Plasma Master File Manuela Leitner

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Contact

•bpsv_biologika@ages.at

•bpsv_praeklinik@ages.at

•bpsv_statistik_sa@ages.at

•bpsv_vete@ages.at

•e.sa@ages.at (EMA-SA)

Department Analytics of Biological Medicinal Products (BAMA)

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Head of department: Heidemarie Schindl (Dieter Pullirsch)

Vaccines Plasma Pool Testing Expert Group Coordinator: Dieter Pullirsch • Belouafa Fatima • Farkas Isabella • Hottowy Brigitte • Ritter Renate • Sammer Cornelia • Stejskal Christoph • Wetzinger Christine • Zechmann Ulrike

Coagulation Factors and Protein Analytics

Expert Group Coordinator: Christoph Kefeder • Berger Renate • Eichmeir Stefanie • Hottowy Brigitte • Staber Eva • Wollein Gabriele

Assistence & Support • Lisa Löffler • Maria

Schwiretz

•Official control authority batch release: plasma pools plasma derived medicinal products vaccines

•Participation: Proficiency testing studies (PTS) biological standardisation program (BSP) testing of centrally authorised medicinal products (CAP)

•Elaboration and assessment: monographs, methods and reference preparations

Contact: chargen@ages.a omcl-at@ages.at

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Duties and responsibilities

Working Parties & Committees

• European Pharmacopoeia Commission Friedrich Lackner

• European Pharmacopoeia Expert Groups Group 6B (Human Blood and Blood Products) P4 Bio Biologicals Friedrich Lackner Group 15 (Sera and Vaccines) Heidemarie Schindl Group 15V (Veterinary Sera and Vaccines) Monoclonal Antibodies, Gene Therapy Products Dieter Pullirsch Allergens Christoph Kefeder

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Head of department: Roman Macas (Thomas Lang)

Chromatographic , Spectroscopic & Identification Methods (CSIM) Expert Group Coordinator: Thomas Lang • Waltraud Doiber • Andreas Hackl • Andrea Hölzel • Zdenek Janicek • Franz Lechner • Hermann Leth • Rosemarie Schuch • Martina Waismayer

Pharmaceutical-Technical, Pharmacognostic & Volumetric Methods (PPMM) Expert Group Coordinator: Reinhard Stark • Elisabeth Egerth • Brigitte Nedved • Gerhard Nesetril • Silvester Ölzant • Christine Schmidt • Josef Steinhäusler • Nicole Walter

Support: • Brigitte Kunz • Brabenetz Andrea

Analysis Chemical-pharmaceutical Medicinal Products (CPAA)

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Duties and responsibilities

• Market surveillance of legal/illegal Medicinal Products Analysis of products based on routine sampling plan or based on quality defect report Analysis of unknown or suspicious medicinal products

• Participation: Proficiency testing studies (PTS), testing of centrally authorised medicinal products (CAP)

• Elaboration and assessment: monographs, methods and reference preparations

• Stockpiled medicines: Analysis to monitor the quality of stockpiled medicines to extent the period of use

Contact: basg.cpaa@ages.at basg.oeab@ages.at