Institute Assessment & Analytics (BGA) Dr. Gerhard Beck BGA AGES Medizinmarktaufsicht Erfahrung mit der neuen Struktur Wien, 15. Sept. 2014 www.ages.at Austrian Agency for Health and Food Safety
Assessment & Analytics G. Beck Consultants: Friedrich Lackner Andreas Mayrhofer EMA EDQM A s s e s s m e n t CASE Clinical Assessment of Safety & Efficacy B. Tucek BPSV Biologicals, Preclinical & Statistical Assessment, Veterinary Medicinal Products 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 1090 Zimmermanng. 2
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
Department Clinical Assessment of Safety & Efficacy (CASE) Head of department: Barbara Tucek (Jan Neuhauser) CP Admin Team Stefan Fringer, Tanja Knapp, Sylvia Pach Scientific Advice René Anour (Andreas Kirisits) CP chem, biosim Jan Neuhauser (Christina Kerscher) Biologika Brigitte Müller (Daniela Philadelphy) HERB (LCM/QUAL: Länger) 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 Beatrix Cihal, Regina Mekonnen, Brigitta Sabor 4
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 EMA Contact (NASA): Nationaler Scientific Advice EMA-Scientific Advice scientificadvice@ages.at 5
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 6
Department Assessment-Pharmacovigilance (APHV) Head of department: Barbara Tucek (Jan Neuhauser) Assessment - Pharmacovigilance Expert Group Coordinator Sonja Hrabcik (Susanne Wolf) Marianne Lunzer, Ramona Mirzaei, Leonhard-Key Mien, Manuela Mondl, Claudia Reichelt, Irmgard Resch, Katja Valent, Susanne Wolf Contact: CASE_PHV@ages.at 7
Pharmacovigilance 8
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) 9
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 10
Biologicals, Preclinical & Statistical Assessment, Veterinary Medicinal Products (BPSV) Head of department: Barbara Zemann (Ulrike Heißenberger) 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 Support: Daniela Gutschi Group Veterinary Medicinal Products Eugen Obermayr Brigitte Hauser Anja Kotschwar Ingrid Langner Ines Lindner Gabriele Rothmüller (Petra Günter- Stadlmaier) 11
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) 12
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 13
Contact bpsv_biologika@ages.at bpsv_praeklinik@ages.at bpsv_statistik_sa@ages.at bpsv_vete@ages.at e.sa@ages.at (EMA-SA) 14
Department Analytics of Biological Medicinal Products (BAMA) Head of department: Heidemarie Schindl (Dieter Pullirsch) 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 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 15
Duties and responsibilities 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 16
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 17
Analysis Chemical-pharmaceutical Medicinal Products (CPAA) Head of department: Roman Macas (Thomas Lang) Support: Brigitte Kunz Brabenetz Andrea 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 18
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 19