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The Paul Ehrlich Institute - Centre of Excellence for Vaccines, Blood Products and Emerging Therapies The Paul Ehrlich Institute - Centre of Excellence for Vaccines, Blood Products and Emerging Therapies Johannes Löwer and co-workers 8th DGRA Annual Congress Bonn, 9 and 10 May 2006 www.pei.de PEI Paul Ehrlich 1896 PEI Potency of Anti-D Immunoglobulin Correlation between PEI’s and Manufacturer’s Results 1800 A A A A A A A AA A Measurement C C C B B C CC C C 600 900 1200 1500 PEI 600 900 1200 1500 1800 Manufacturer History 1896 Institute for Serum Research and Serum Examination, Berlin-Steglitz 1899 Royal Institute for Experimental Therapy, Frankfurt/Main 1947 Paul-Ehrlich-Institut - State Institute for Experimental Therapy, Frankfurt/Main 1972 Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Frankfurt/Main 1990 Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines, Langen/Hessen PEI PEI: Areas of Responsibility • Vaccines (human, veterinary) • Sera, immunoglobulins, monoclonal antibodies • Allergens (diagnostic, therapeutic) • Blood products (plasma derived, recombinant) • Blood components for transfusion • Gene transfer products • Cell therapy products (somatic, xenogeneic) • Tissues • (Engineered tissues) PEI PEI: Areas of Responsibility • Vaccines (human, veterinary) • Sera, immunoglobulins, monoclonal antibodies • Allergens (diagnostic, therapeutic) • Blood products (plasma derived, recombinant) • Blood components for transfusion • Gene transfer products • Cell therapy products (somatic, xenogeneic) • Tissues • (Engineered tissues) PEI Royal Institute of Experimental Medicine PEI: Duties • Official batch release • Authorisation of medicinal products • Scientific advice • Pharmakovigilance • Expert support for inspections • Permission of clinical studies • Experimental research • Advice to government • Research PEI PEI: Duties • Official batch release • Authorisation of medicinal products • Scientific advice • Pharmakovigilance • Expert support for inspections • Permission of clinical studies • Experimental research • Advice to government • Research PEI Sequence of the Evaluation of an Application • Appointment of the rapporteur by the CHMP • Appointment of the leading unit at the PEI PEI Paul-Ehrlich-Institut Bundesamt für Sera und Impfstoffe Institutsleitung Forschungsbeauftragter Forschung beim Forschung beim Präsidenten Präsident und Professor Referat L1 Referat L2 Referat L3 Referat L4 Referat L5 Präsidenten Fachgebiet Pr1 Leitungsassistenz, Grundsatzfragen, Presse, Qualitäts- Europäische Fachgebiet Pr2 Transmissible spongiforme Hr. Prof. Dr. Löwer Sprachendienst Zentrale Steuerung Öffentlichkeitsarbeit management Verfahren Retroelemente Enzephalopathien Hr. Prof. Dr. Vieths Fr. Plumbaum° Hr. Wiegelmann° Fr. Dr. Stöcker Fr. Dr. v. Wangenheim Fr. Dr. Schröder° Fr. Dr. Löwer Hr. Dr. Montrasio Vizepräsident und Professor Hr. Prof. Dr. Cichutek Abteilung Z Abteilung S Abteilung 1 Abteilung 2 Abteilung 3 Abteilung 4 Abteilung 5 Abteilung 6 Abteilung 7 Verwaltung Sicherheit von Bakteriologie Virologie Immunologie Veterinärmedizin Allergologie Medizinische Hämatologie / Arzneimitteln und Biotechnologie Transfusionsmedizin Medizinprodukten Hr. Dr. Frieser Fr. Dr. Keller-Stanislawski° Hr. Dr. Haase Hr. PD Dr. Sutter Hr. Dr. Kalinke Hr. Dr. Moos Hr. Prof. Dr. Vieths Hr. Prof. Dr. Cichutek Hr. Prof. Dr. Seitz Div. 1 Bacteriology Div. 2 Virology Div. 3 Immunology Div. 4 Veterinary medicine Div. 5 Allergology Div. 6 Medicinal Biotechnology Div. 7 Hematology/Transfusion medicine Div. S Safety of medicinal products and medical devices Div. Z Administration PEI Sequence of the Evaluation of an Application • Appointment of the rapporteur by the CHMP • Appointment of the leading unit at the PEI • Appointment of the expert team PEI Paul-Ehrlich-Institut Bundesamt für Sera und Impfstoffe Institutsleitung Forschungsbeauftragter Forschung beim Forschung beim Präsidenten Präsident und Professor Referat L1 Referat L2 Referat L3 Referat L4 Referat L5 Präsidenten Fachgebiet Pr1 Leitungsassistenz, Grundsatzfragen, Presse, Qualitäts- Europäische Fachgebiet Pr2 Transmissible spongiforme Hr. Prof. Dr. Löwer Sprachendienst Zentrale Steuerung Öffentlichkeitsarbeit management Verfahren Retroelemente Enzephalopathien Hr. Prof. Dr. Vieths Fr. Plumbaum° Hr. Wiegelmann° Fr. Dr. Stöcker Fr. Dr. v. Wangenheim Fr. Dr. Schröder° Fr. Dr. Löwer Hr. Dr. Montrasio Vizepräsident und Professor Hr. Prof. Dr. Cichutek Prüflabor für IVD PEI-IVD Fr. Dr. S. Nick Abteilung Z Abteilung S Abteilung 1 Abteilung 2 Abteilung 3 Abteilung 4 Abteilung 5 Abteilung 6 Abteilung 7 Verwaltung Sicherheit von Bakteriologie Virologie Immunologie Veterinärmedizin Allergologie Medizinische Hämatologie / Arzneimitteln und Biotechnologie Transfusionsmedizin Medizinprodukten Hr. Dr. Frieser Fr. Dr. Keller-Stanislawski° Hr. Dr. Haase Hr. PD Dr. Sutter Hr. Dr. Kalinke Hr. Dr. Moos Hr. Prof. Dr. Vieths Hr. Prof. Dr. Cichutek Hr. Prof. Dr. Seitz Referat Z1 Referat S1 Fachgebiet 1/1 Fachgebiet 2/1 Fachgebiet 3/1 Fachgebiet 4/1 Fachgebiet 5/1 Fachgebiet 6/1 Fachgebiet 7/1 Personal Arzneimittelsicherheit Bakteriologische Virusimpfstoffe Immunchemie Bakterielle Impfstoffe Test-Allergene Gentransfer- Gerinnungsfaktoren I Impfstoffe I und Immunsera Arzneimittel I Hr. Posselt Fr. Dr. Keller-Stanislawski Hr. Dr. Öppling Hr. Dr. Pfleiderer Hr. Dr. Giess Fr. Dr. E. Werner° Hr. Dr. Höltz Hr. PD Dr. Buchholz Hr. PD Dr. Dodt* Referat Z2 Referat S2 Fachgebiet 1/2 Fachgebiet 2/2 Fachgebiet 3/2 Fachgebiet 4/2 Fachgebiet 5/2 Fachgebiet 6/2 Fachgebiet 7/2 Haushalt Sicherheit von Bakteriologische HIV-Impfstoffe, Mono- und polyklonale Virusimpfstoffe I Therapie-Allergene Gentransfer- Gerinnungsfaktoren II In-vitro-Diagnostika Impfstoffe II AIDS Antikörper Arzneimittel II Hr. Robeck Hr. Dr. Bornhak Hr. Dr. Schwanig Hr. PD Dr. A. Werner Fr. Dr. Schäffner Fr. Dr. Jungbäck Fr. Dr. May Hr. PD Dr. Schweizer* Hr. PD Dr. Dodt Referat Z3 Referat S3 Fachgebiet 1/3 Fachgebiet 2/3 Fachgebiet 3/3 Fachgebiet 4/3 Fachgebiet 5/3 Fachgebiet 6/3 Fachgebiet 7/3 Innerer Dienst Sicherheit Mikrobielle Sicherheit Diagnostika Morphologie Virusimpfstoffe II Klinische Allergologie Somatische Chargenprüfung veterinärmedizinischer und Parasitologie und Toxikologie Zelltherapeutika Blutprodukte, Mittel, Tierschutz Albumin, Logistik Hr. Gunkel Hr. Dr. Montag-Lessing Fr. Dr. Nick Hr. Dr. Boller Fr. Dr. Duchow Fr. Dr. Lüderitz-Püchel Hr. Dr. Flory° Hr. Dr. Cußler° Hr. Dr. Unkelbach Referat Z4 Referat S4 Fachgebiet 1/4 Fachgebiet 2/4 Fachgebiet 3/4 Fachgebiet ZT Fachgebiet 5/4 Fachgebiet 6/4 Fachgebiet 7/4 Technik Rechtsangelegenheiten Biostatistik Molekulare Pathologie Tumorimpfstoffe, Zentrale Tierhaltung Entwicklung und Xenogene Transfusionsmedizin Zellbank, Medien Standardisierung Zelltherapeutika Hr. Pieschner-v. Meltzer Fr. Ruoff° Hr. Dr. Volkers Hr. Dr. Nübling Hr. Frieling Hr. Dr. Plesker Hr. Dr. Scheurer* Hr. PD Dr. Tönjes Fr. Dr. Heiden Referat Z5 Fachgebiet 2/5 Fachgebiet 7/5 Organisation, Virussicherheit Inspektionen: Informationstechnik Schulung, Koordination und Durchführung Hr. Dr. Blümel* Hr. Dr. Frieser External Hr. PD Dr. G. Werner Referat Z6 Arbeitsschutz, expert Genehmigungen Fr. Dr. Pfitzner* Personalrat Gleichstellungs- Schwerbehinderten- Jugend- und *mit der Wahrnehmung der Geschäfte Wissenschaftliche Nachwuchsgruppen Vorsitzende beauftragte vertrauensfrau Auszubildenden- beauftragt (NG) Sprecher: N.N. vertretung ° für die Wahrnehmung der Geschäfte vorgesehen NG1 NG2 NG3 NG4 NG5 Fr. Gravelius Fr. Dr. Krämer Fr. Grote Fr. Zitzmann Dienst- und Fachaufsicht Neue Bioinformatik Zelldifferenzierung Dienstaufsicht Impfstoffstrategien N.N. N.N. N.N. N.N. PEIN.N. Sequence of the Evaluation of an Application • Appointment of the rapporteur by the CHMP • Appointment of the leading unit at the PEI • Appointment of the expert team • Evaluation • Review by the PEI Peer Review Group (Manfred Haase’s idea!) PEI Good Regulatory Practice (GRP) in the PEI Peer Review Group Members: • Experienced scientists not involved in the evaluation of the product in question Aim: • To widen the scientific basis of the decisions made by the assessors • To assist in the decision on critical issues • To provide access to the “regulatory memory” Involvement: • Obligatory in centralised and decentralised procedures and in the co-ordination of “Scientific Advice” PEI Sequence of the Evaluation of an Application • Appointment of the rapporteur by the CHMP • Appointment of the leading unit at the PEI • Appointment of the expert team • Evaluation • Review by the PEI Peer Review Group • Finalization of the assessment report • Support to the CHMP member (Manfred Haase) PEI European Procedures for Products in PEI‘s Remit (until 31 December 2005) Distribution of (Co-)rapporteurships [Hum] 45 40 Co-Rapporteur Rapporteur 35 24 30 25 20 15 13 2 12 10 20 9 6 11 5 1 1 11 2 1 7 7 4 3 5 5 4 5 0 1 2 2 ) I I E K S F R E IT L O E K U E B E F I N S P D N U H ( PEI E D European Procedures for Products in PEI‘s Remit (until 31 December 2005) Distribution of (Co-)rapporteurships [Vet] 16 14 Co-Rapporteur Rapporteur 5 12 10 4 8 14 2 6 10 2 6 4 3 7 6 2 4 1 3 1 2 2 1 1 1 1 1 0 ) I I E K S F R E IT L O K T E B E F I N A P D N U ( PEI E D European Procedures for Products in PEI‘s Remit (until 31 December 2005) Distribution of RMSs with Germany involved [Hum] Allergene 40 Ig 35 1 MAK Blutprodukte 30 9 Komb. Impfstoff Viraler Impfstoff 25 2 Bakt. Impfstoff 20 7 15 4 1 10 2 9 1 1 4 1 4 2 5 2 2 4 4 5 4 1 3 1 2 1 0 1 1 1 I) L K E FR IT N SE AT P BE DK U E ( D PEI European Procedures for Products in PEI‘s Remit (until 31 December 2005) Distribution of RMSs with Germany
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