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PEI AIFA European Conference on Clinical Research for Decision Making www.pei.de Rome, 30 March 2007 The German experience Johannes Löwer Paul-Ehrlich-Institut.

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Präsentation zum Thema: "PEI AIFA European Conference on Clinical Research for Decision Making www.pei.de Rome, 30 March 2007 The German experience Johannes Löwer Paul-Ehrlich-Institut."—  Präsentation transkript:

1 PEI AIFA European Conference on Clinical Research for Decision Making Rome, 30 March 2007 The German experience Johannes Löwer Paul-Ehrlich-Institut

2 PEI 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: Areas of Responsibility

3 PEI PEI: Duties Authorisation of medicinal products Official batch release Scientific advice Pharmakovigilance Expert support for inspections Permission of clinical studies Experimental research Advice to government

4 PEI PEI: Holistic Approach for each Group of Medicinal Products Authorisation of medicinal products Official batch release Scientific advice Pharmakovigilance Expert support for inspections Permission of clinical studies Experimental research Advice to government

5 PEI Sequence of the Evaluation of an Application Application for rapporteurship defining the evaluation team and its expertise

6 PEI Prüflabor für IVD PEI-IVD Fr. Dr. S. Nick Dienst- und Fachaufsicht Dienstaufsicht *mit der Wahrnehmung der Geschäfte beauftragt ° für die Wahrnehmung der Geschäfte vorgesehen Institutsleitung Präsident und Professor Hr. Prof. Dr. Löwer Vizepräsident und Professor Hr. Prof. Dr. Cichutek Forschungsbeauftragter Hr. Prof. Dr. Vieths Forschung beim Präsidenten Fachgebiet Pr1 Transmissible spongiforme Enzephalopathien Hr. Dr. Montrasio Forschung beim Präsidenten Fachgebiet Pr2 Retroelemente Fr. Dr. Löwer Personalrat Vorsitzende Fr. Gravelius Gleichstellungs- beauftragte Fr. Dr. Krämer Schwerbehinderten- vertrauensfrau Fr. Grote Jugend- und Auszubildenden- vertretung Fr. Zitzmann NG1 Neue Impfstoffstrategien N.N. NG2 Bioinformatik N.N. NG3 Zelldifferenzierung N.N. NG4 N.N. NG5 N.N. Wissenschaftliche Nachwuchsgruppen (NG) Sprecher: N.N. Abteilung 4 Veterinärmedizin Hr. Dr. Moos Fachgebiet 4/1 Bakterielle Impfstoffe und Immunsera Fr. Dr. E. Werner° Fachgebiet 4/2 Virusimpfstoffe I Fr. Dr. Jungbäck Fachgebiet 4/3 Virusimpfstoffe II Fr. Dr. Duchow Fachgebiet ZT Zentrale Tierhaltung Hr. Dr. Plesker Fachgebiet 6/4 Xenogene Zelltherapeutika Hr. PD Dr. Tönjes Abteilung 6 Medizinische Biotechnologie Hr. Prof. Dr. Cichutek Fachgebiet 6/1 Gentransfer- Arzneimittel I Hr. PD Dr. Buchholz Fachgebiet 6/2 Gentransfer- Arzneimittel II Hr. PD Dr. Schweizer* Fachgebiet 6/3 Somatische Zelltherapeutika Hr. Dr. Flory° Abteilung 5 Allergologie Hr. Prof. Dr. Vieths Fachgebiet 5/1 Test-Allergene Hr. Dr. Höltz Fachgebiet 5/2 Therapie-Allergene Fr. Dr. May Fachgebiet 5/3 Klinische Allergologie und Toxikologie Fr. Dr. Lüderitz-Püchel Fachgebiet 5/4 Entwicklung und Standardisierung Hr. Dr. Scheurer* Fachgebiet 7/1 Gerinnungsfaktoren I Hr. PD Dr. Dodt* Fachgebiet 7/2 Gerinnungsfaktoren II Hr. PD Dr. Dodt Fachgebiet 7/3 Chargenprüfung Blutprodukte, Albumin, Logistik Hr. Dr. Unkelbach Fachgebiet 7/4 Transfusionsmedizin Fr. Dr. Heiden Fachgebiet 7/5 Inspektionen: Schulung, Koordination und Durchführung Hr. PD Dr. G. Werner Abteilung 7 Hämatologie / Transfusionsmedizin Hr. Prof. Dr. Seitz Abteilung 1 Bakteriologie Hr. Dr. Haase Fachgebiet 1/1 Bakteriologische Impfstoffe I Hr. Dr. Öppling Fachgebiet 1/2 Bakteriologische Impfstoffe II Hr. Dr. Schwanig Fachgebiet 1/3 Mikrobielle Sicherheit und Parasitologie Hr. Dr. Montag-Lessing Fachgebiet 1/4 Biostatistik Hr. Dr. Volkers Referat S4 Rechtsangelegenheiten Fr. Ruoff° Abteilung S Sicherheit von Arzneimitteln und Medizinprodukten Fr. Dr. Keller-Stanislawski ° Referat S1 Arzneimittelsicherheit Fr. Dr. Keller-Stanislawski Referat S2 Sicherheit von In-vitro-Diagnostika Hr. Dr. Bornhak Referat S3 Sicherheit veterinärmedizinischer Mittel, Tierschutz Hr. Dr. Cußler° Abteilung 3 Immunologie Hr. Dr. Kalinke Fachgebiet 3/1 Immunchemie Hr. Dr. Giess Fachgebiet 3/2 Mono- und polyklonale Antikörper Fr. Dr. Schäffner Fachgebiet 3/3 Morphologie Hr. Dr. Boller Fachgebiet 3/4 Tumorimpfstoffe, Zellbank, Medien Hr. Frieling Referat Z6 Arbeitsschutz, Genehmigungen Fr. Dr. Pfitzner* Abteilung Z Verwaltung Hr. Dr. Frieser Referat Z1 Personal Hr. Posselt Referat Z2 Haushalt Hr. Robeck Referat Z3 Innerer Dienst Hr. Gunkel Referat Z4 Technik Hr. Pieschner-v. Meltzer Referat Z5 Organisation, Informationstechnik Hr. Dr. Frieser Abteilung 2 Virologie Hr. PD Dr. Sutter Fachgebiet 2/1 Virusimpfstoffe Hr. Dr. Pfleiderer Fachgebiet 2/2 HIV-Impfstoffe, AIDS Hr. PD Dr. A. Werner Fachgebiet 2/3 Diagnostika Fr. Dr. Nick Fachgebiet 2/4 Molekulare Pathologie Hr. Dr. Nübling Fachgebiet 2/5 Virussicherheit Hr. Dr. Blümel* Referat L3 Presse, Öffentlichkeitsarbeit Fr. Dr. Stöcker Referat L2 Grundsatzfragen, Zentrale Steuerung Hr. Wiegelmann° Referat L5 Europäische Verfahren Fr. Dr. Schröder° Referat L4 Qualitäts- management Fr. Dr. v. Wangenheim Referat L1 Leitungsassistenz, Sprachendienst Fr. Plumbaum° External expert

7 PEI Sequence of the Evaluation of an Application Application for rapporteurship defining the evaluation team and its expertise Appointment of the rapporteur by the CHMP Evaluation Review by the PEI Peer Review Group

8 PEI 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 Good Regulatory Practice (GRP) in the PEI Peer Review Group

9 PEI Sequence of the Evaluation of an Application Application for rapporteurship defining the evaluation team and its expertise Appointment of the rapporteur by the CHMP Evaluation Review by the PEI Peer Review Group Finalization of the assessment report Support to the CHMP member

10 PEI European Procedures for Products in PEIs Remit (until 31 December 2005) Distribution of (Co-)rapporteurships [Hum]

11 PEI European Procedures for Products in PEIs Remit (until 31 December 2005) Distribution of RMSs with Germany involved [Hum]

12 PEI Scientific Advice [Hum] for Biological Products Co-ordination by PEI (in Percent)

13 PEI PEI: Duties Authorisation of medicinal products Official batch release Scientific advice Pharmakovigilance Expert support for inspections Permission of clinical studies Experimental research Advice to government

14 PEI Major Research Areas Safety of Biological and Biotechnology Medicines New Test Methods Pathogenesis of Prion Diseases and Viral Infections Viral Gene Transfer and Cell Therapy Immunobiology of Allergens

15 PEI Research Grants

16 PEI Widening the Basis for Decision Experimental investigations –Potency of anti-D immunoglobulins –Potency of recombinant Factor VIII –Dose calculation for first-in-man-studies

17 PEI Manufacturer Measurement A A A A A A A A A A B B C C C C C C C C Potency of Anti-D Immunoglobulin Correlation between PEIs and Manufacturers Results

18 PEI Comparison of potency of a rec. FVIII obtained with different Chromogenic Assays

19 PEI

20 In vitro titration of TGN1412 binding to CD28 expressed by human T cells µg/ml unstained TGN 1412-Alexa µg/ml specific binding % specific binding TGN 1412Rituximab

21 PEI Widening the Basis for Decision Experimental investigations Epidemiological investigations –Tick-born encephalitis in children –Sudden unexpected death in the second year of life after vaccination

22 PEI PEI Study: Severe TBE in Children TBE in children (Germany) A survey for the years 1997 and 1998 Collection of clinically relevant cases and evaluation of the natural course of the disease in children up to 16 years of age Questionnaires were sent to 478 pediatric and neurological hospitals. Response rate: 81 % (n= 387) n=17 cases (n=14 meningitis, n=2 meningo- encephalitis, n=1 meningitis + cerebellitis) Age: median 8 yrs (min. 3 til max. 14 yrs) On average 9 days stay in hospital No permanent damages!

23 PEI Change of the Manufacturing Process: Fever after a TBE- Vaccine, Germany Removal of Thiomersal Removal of Albumin

24 Schlaud 2005 Background Problem: Spontaneous notifications of > 20 cases of death in close temporal association (< 3 days) to hexavalent vaccination –All died suddenly and unexpectedly –Four of them died in their second year of life –Statistical analyses estimating the observed versus expected cases revealed a standardised mortality ratio (SMR) of 23.5 (95% CI 4.8–68.6) within 2 days after vaccination for one of the two licensed hexavalent vaccines Limitations of current assessment: based on a low absolute number of cases high probability of incomplete case-ascertainment case detection may be biased data on exposure may be incomplete data on background incidence may be incomplete standardised study was deemed necessary PEI

25 Dr. Bärbel-Maria Kurth PEI

26 Schlaud 2005 Study questions Is there a temporal association between vaccination and risk of sudden death in the first two years of life? For what length of time after vaccination is the risk of death potentially increased? Is this potential association qualitatively and quantitatively the same at different stages of life? Is this potential association the same across different –hexavalent- vaccines? Is there a common pathological mechanism? Is the risk of sudden death associated with vaccination? The complete number of answers cannot be obtained by a single study approach PEI

27 Schlaud 2005 Study Protocol Structure Pathological approach Epidemiological approach Qualitative research Standardised 1. case ascertainment 2. autopsies children aged 9-23 mo Additional in depths investigations Quantitative research All cases of death in children aged 1-23 mo Self Controlled Case Series Case Control Study PEI

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