Brigitte Keller-Stanislawski

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1 Curriculum vitae PERSONAL INFORMATION Brigitte Keller-Stanislawski WORK EXPERIENCE October 2003 Present Head of the Department Safety of Medicinal Products and Medicinal Devices Hemovigilance October 1996 September 2003 Head of the Unit October 1994 September 1996 Assessor Assessor for of vaccines, blood products and sera Clinical Assessor Vaccines, Blood derived medicinal products and recombinant Factor IX September 1987 October 1993 Senior Medical Officer in Clinical Pharmacology Johann Wolfgang Goethe-University Hospital, Frankfurt (Germany) Pharmacokinetics and EDUCATION AND TRAINING October 1988 September 1993 Consultant Clinical Pharmacology J.W. Goethe University Frankfurt/Main (Germany) Clinical Pharmacology April 1987 October 1988 Doctor of Medicine J.W. Goethe University Frankfurt/Main (Germany) October 1978 March 1987 Degree in Medicine University of Münster J.W. Goethe University Frankfurt/Main (Germany) ADDITIONAL INFORMATION Expertise Biologicals Pharmacoepidemiology Publications Publications Eckerle I, Keller-Stanislawski B, Santibanez S, Buderus S, Hillmann M, Drosten C, Eis-Hübinger AM. Nonfebrile seizures after mumps, measles, rubella, and varicella-zoster virus combination vaccination with detection of measles virus RNA in serum, throat, and urine. In: Clin Vaccine Immunol Jul;20(7): doi: /CVI Epub 2013 May 1. Hilger A, Arras-Reiter C, Keller-Stanislawski B, Ljungberg B, Male C, Mentzer D, Seitz R, Silvester G. 15/12/15 European Union, Page 1 / 5

2 Comment on: Mannucci, P. M. Evolution of the European guidelines for the clinical development of factor VIII products. In: Haemophilia May;19(3): doi: /hae Mentzer D, Meyer H, Keller-Stanislawski B. Safety and tolerability of monovalent measles and combined measles, mumps, rubella, and varicella vaccines. In: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Sep;56(9): doi: Falkenhorst G, Harder T, Remschmidt C, Terhardt M, Zepp F, Ledig T, Wicker S, Keller-Stanislawski B, Mertens T. Background paper to the recommendation for the preferential use of live-attenuated influenza vaccine in children aged 2-6 years in Germany. In: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Nov;56(11): Funk MB, Gross N, Gross S, Hunfeld A, Lohmann A, Guenay S, Hanschmann KM, Keller- Stanislawski B. Thromboembolic events associated with immunoglobulin treatment.in: Vox Sang Jul;105(1): doi: /vox Epub 2013 Feb 9. Mentzer D, Prestel J, Adams O, Gold R, Hartung HP, Hengel H, Kieseier BC, Ludwig WD, Keller- Stanislawski B. Case definition for progressive multifocal leukoencephalopathy following treatment with monoclonal antibodies. J Neurol Neurosurg Psychiatry Sep;83(9): Dudareva-Vizule S, Koch J, An der Heiden M, Oberle D, Keller-Stanislawski B, Wichmann O. Impact of rotavirus vaccination in regions with low and moderate vaccine uptake in Germany. Hum Vaccin Immunother Sep 7;8(10) Marc Oppermann, Juliane Fritzsche, Corinna Weber-Schoendorfer, Brigitte Keller-Stanislawski, Arthur Allignol, Reinhard Meister, Christof Schaefer. A(H1N1)v2009: A controlled observational prospective cohort study on vaccine safety in pregnancy. Vaccine Jun 22;30(30): H.-P. Hartung, B. Keller-Stanislawski, R.A. Hughes, H.C. Lehmann. Guillain-Barré-Syndrom nach Exposition mit Influenza. Nervenarzt : M Vinhas de Souza, B Keller-Stanislawski, K Blake, A Hidalgo-Simon, P Arlett, G Dal Pan. Drug- Induced PML: A Global Agenda for a Global challenge. In: Clin Pharmacol Ther Apr ;91(4): Funk MB, Lohmann A, Guenay S, Henseler 0, Heiden M, Hanschmann KM, Keller-Stanislawski B, Transfusion-Transmitted Bacterial lnfections- Haemovigilance Data of German Blood Establishments ( ). Transfus Med Hernother 2011;38(4): Funk MB, Guenay S, Lohmann A, Henseler 0, Heiden M, Hanschmann KM, Keller-Stanislawski B: Benefit of transfusion-related acute lung injury risk-minimization measures - German haemovigilance data ( ), Vox Sang Oct4. doi: /j x von Spiczak S, Helbig I, Drechsei-Baeuerle U, Muhle H, van Baalen A, van Kempen MJ, Lindhaut D, Scheffer IE, Berkovic SF, Stephani U, Keller-Stanislawski B. A retrospective population-based study on seizures related to childhood vaccination, Epilepsia 2011Aug;52(8): Weisser K, Barth I, Keller-Stanislawski B Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. Vaccine safety, 2009 Nov; 52(11): Keller-Stanislawski B, Reil A, Günay S, Funk MB Frequency and severity of transfusion-related acute lung injury--german haemovigilance data ( ).Vox Sang 2010 Jan;98(1):70-7. Keller-Stanislawski B, Lohmann A, Günay S, Heiden M, Funk MB The German Haemovigilance System--reports of serious adverse transfusion reactions between 1997 and Transfus Med 2009 Dec;19(6):340-9 Sehneeweiss B, Pfleiderer M, Keller-Stanislawski B Vaccination safety update, Dtsch Arztebllnt Aug;105(34-35):590-5 Nübling CM, Heiden M, Chudy M, Kress J, Seitz R, Keller-Stanislawski B, Funk MB 15/12/15 European Union, Page 2 / 5

3 Experience of mandatory nucleic acid test (NAT) Screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions. Transfusion 2009 Sep;49(9): Reil A, Keller-Stanislawski B, Günay S, Bux J Specificities of leucocyte alloantibodies in transfusion-related acute lung injury and results of leucocyte antibody screening of blood donors. Vox Sang Nov;95(4):313-7 Barth I, Krafft H, Weber G, Keller-Stanislawski B, Cichutek K Good clinical practice in the European Union. Hum GeneTher 2008 May;19(5): Neugebauer B, Drai C, Haase M, Hilger A, Keller-Stanislawski B, Laitinen-Parkkonen P, Mentzer D, Rasmussen C, Ratignier C, Seitz R Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelines. Haemophilia 2008 Jan;14(1):142-4 Weisser K, Meyer C, Petzold D, Mentzer D, Keller-Stanislawski B Adverse drug reactions following immunization in Germany pursuant to the German lnfection Protection Act and the German Medicinal Products Act from January 1, 2004 to December 31, 2005, Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Nov;50(11): Kohl KS, Gidudu J, Bonhoeffer J, Braun MM, Buettcher M, Chen RT, Drammeh B, Duclos P, Heijbel H, Heininger U, Hummelman E, Jefferson T, Keller-Stanislawski B, Loupi E, Marcy SM The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine Aug 1;25(31): Weisser K, Keller-Stanislawski B Nebenwirkungen von Impfungen und lmpfkomplikationen, pädiatrie hautnah, S2, 2006, S46-S48 Keller-Stanislawski, B., Heuß, N., Meyer, C Adverse events following immunisation in Germany from to , Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz (2004) 47: Weisser, K., Bauer, K., Volkers, P., Keller-Stanislawski. B Thiomersal and immunisations. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz (2004) 47: Andus T, Stange EF, Höffler D, Keller-Stanislawski B Suspected cases of severe side effects after infliximab (Remicade) in. Med Klin (2003): 98: Graul A, Heiden M, Gräf K, Keller-Stanislawski B Hämovigilanz in Deutschland - Berichte an das Paul-Ehrlich-lnstitut über Verdachtsfälle von Transfusionsreaktionen im Beobachtungszeitraum Januar 1995 bis Dezember Transfusion Medicine and Hemotherapy 2003, 30: Keller-Stanislawski B, Hartmann K Auswertung der Meldungen von Verdachtsfällen auf Impfkomplikationen nach dem lnfektionsschutzgesetz. Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 2002, Hartmann K, Keller-Stanislawski B Rekombinante Hepatitis-B- Impfstoffe und Verdachtsfälle unerwünschter Reaktionen. Bundesgesundheitsbi -Gesundheitsforsch-Gesundheitsschutz, 2002, Keller-Stanislawski B Feasibility of improving safety beyend certain Iimits in clinical trials. Vaccine 2002, 20: S45-S46 Schosser R, Keller-Stanislawski B, Nübling CM, Löwer J Causality assessment of suspected virus transmission by human plasma products. Transfusion, 2001, 41, Keller-Stanislawski B, Hartmann K Existiert ein Zusammenhang zwischen Impfungen und Typ-1-Diabtes mellitus bei Kindern und Jugendlichen? Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 2001, 44: Hartmann K, Keller-Stanislawski B Verdachtsfälle unerwünschter Arzneimittelwirkungen (UAW) nach Anwendung von Impfstoffen mit attenuierter Masern- Komponente, Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 15/12/15 European Union, Page 3 / 5

4 2001, Lüderitz-Püchel U, Keller-Stanislawski B, Haustein D Neubewertung des Risikos von Test- und Therapieallergenen. Bundesgesundheitsbi- Gesundheitsforsch-Gesundheitsschutz, 2001, Fischer M, Keller-Stanislawski B, Schober-Bendixen S, Schosser R, Hacke K, Hartung T, Montag T. Effect of the preservative thiomersal on the release of interleukin-1 beta from human peripheral blood cells. ALTEX. 2001;18(1):47-9. Heiden M, Keller-Stanislawski B Leucodepletion and regulatory aspects in Germany. Transfus Sei Feb-Apr;22(1-2):69-70 Graul A, Keller-Stanislawski B Hämevigilanz von Blutprodukten. Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 1999, 42: Chudy M, Budek I, Keller-Stanislawski B et al A new duster of hepatitis A infection in hemophilics traced to a contaminated plasma pool. J Med Virology. 1999, 57/2: Theilig C, Bernd A, Ramirez-Bosca, Gormar FF, Breitner-Hahn J, Keller-Stanislawski B et al Reactions to keratinocytes in vitro after application of nicotine. Skin Pharmacology, 1994, 7/6: Merz PG, Keller-Stanislawski B, Huber T et al Transdermal nicotine in smoking cessation and involvement of non-specific influences. lnt J Clin Pharm Ther Tox, 1993, 31/10: Keller-Stanislawski B, Caspary S. Merz PG et al Transdermal nicotine Substitution: Pharmacokinetics of nicotine and cotinine. lnt J Clin Pharm Ther Tox, 1992, 42/9: Rietbrack S, Keller-Stanislawski B, Thurmann P et al Pharmacokinetic profile of a novel slow release preparation of molsidomine. Euro J Clin Pharm, 1992, 43/3 ( ). Keller-Stanislawski B, Marschner JP, Rietbrack N Pharmacokinetics of low-dose isosorbide dinitrate and metabolites after buccal or oral administration. Drug Research 1992,4271: Keller-Stanislawski B, Osowski U, Rietbrack N Behandlung der chronischen Herzinsuffizienz. Wie bewährt sich Digitoxin in der Praxis? Therapiewoche, 1991, 41/27-28: Caspary S, Keller-Stanislawski B, Huber T, Merz PG Pharmacokinetics of nicotine after application of a 30 cm sup 82) nicotine patch under steady state conditions. lnt J Clin Pharm Ther Tox, 1991, 29/3: Keller-Stanislawski B, Rietbrack N Bioavailability of two slow-release formulations of verapamil. Drug Research 1990, 40/10: Projects Memberships Co-opted Member (scientific expert) of PRAC ( Risk Assessment Committee) at EMA Extraordinary Member of the Committee of Medicines of the German Medical Association (AKdÄ) Member of the Adverse Drug Reaction Working Group of the German Medical Association (UAW- Ausschuss der AkdÄ) Member of the European Hemovigilance Network (EHN) Steering Committee Brighton Collaboration Vaccine Working Party of the CHMP 15/12/15 European Union, Page 4 / 5

5 Member of Global Advisory Committee on Vaccine Safety/WHO. PEI representative: German Standing Vaccination Committee (Ständige Impfkommission) Other Relevant Information 15/12/15 European Union, Page 5 / 5