Curriculum vitae PERSONAL INFORMATION Brigitte Keller-Stanislawski WORK EXPERIENCE October 2003–Present Head of the Department Safety of Medicinal Products and Medicinal Devices Paul-Ehrlich-Institut (Germany) Pharmacovigilance Hemovigilance October 1996–September 2003 Head of the Pharmacovigilance Unit Paul-Ehrlich-Institut (Germany) Pharmacovigilance October 1994–September 1996 Pharmacovigilance Assessor Paul-Ehrlich-Institut (Germany) Pharmacovigilance Assessor for Pharmacovigilance 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 Pharmacovigilance 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 Pharmacovigilance 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. 2013 Jul;20(7):1094-6. doi: 10.1128/CVI.00084-13 . Epub 2013 May 1. Hilger A, Arras-Reiter C, Keller-Stanislawski B, Ljungberg B, Male C, Mentzer D, Seitz R, Silvester G. 13/12/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 1 / 5 Curriculum vitae Brigitte Keller-Stanislawski Comment on: Mannucci, P. M. Evolution of the European guidelines for the clinical development of factor VIII products. In: Haemophilia. 2013 May;19(3):349-50. doi: 10.1111/hae.12151 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. 2013 Sep;56(9):1253-9. 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. 2013 Nov;56(11):1557-1564. Funk MB, Gross N, Gross S, Hunfeld A, Lohmann A, Guenay S, Hanschmann KM, KellerStanislawski B. Thromboembolic events associated with immunoglobulin treatment.in: Vox Sang. 2013 Jul;105(1):5464. doi: 10.1111/vox.12025. Epub 2013 Feb 9. Mentzer D, Prestel J, Adams O, Gold R, Hartung HP, Hengel H, Kieseier BC, Ludwig WD, KellerStanislawski B. Case definition for progressive multifocal leukoencephalopathy following treatment with monoclonal antibodies. J Neurol Neurosurg Psychiatry. 2012 Sep;83(9):927-33 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. 2012 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. 2012 Jun 22;30(30):4445-52 H.-P. Hartung, B. Keller-Stanislawski, R.A. Hughes, H.C. Lehmann. Guillain-Barré-Syndrom nach Exposition mit Influenza. Nervenarzt 2012 • 83:714–730 M Vinhas de Souza, B Keller-Stanislawski, K Blake, A Hidalgo-Simon, P Arlett, G Dal Pan. DrugInduced PML: A Global Agenda for a Global challenge. In: Clin Pharmacol Ther. 2012 Apr ;91(4):74750. 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 (1997-2010). Transfus Med Hernother 2011;38(4):266-271 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 (2006-2010), Vox Sang. 2011 Oct4. doi: 10.1111/j.1423-0410.2011.01556.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):1506-12 Weisser K, Barth I, Keller-Stanislawski B Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. Vaccine safety, 2009 Nov; 52(11):1053-64 Keller-Stanislawski B, Reil A, Günay S, Funk MB Frequency and severity of transfusion-related acute lung injury--German haemovigilance data (20062007).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 2007. Transfus Med 2009 Dec;19(6):340-9 Sehneeweiss B, Pfleiderer M, Keller-Stanislawski B Vaccination safety update, Dtsch Arztebllnt. 2008 Aug;105(34-35):590-5 Nübling CM, Heiden M, Chudy M, Kress J, Seitz R, Keller-Stanislawski B, Funk MB 13/12/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 2 / 5 Curriculum vitae Brigitte Keller-Stanislawski Experience of mandatory nucleic acid test (NAT) Screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions. Transfusion 2009 Sep;49(9):1850-8 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. 2008 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):441-2. 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. 2007 Nov;50(11):1404-17. 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. 2007 Aug 1;25(31):5671-4. 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 1.1.2001 to 31.12.2003, Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz (2004) 47: 1151-1164 Weisser, K., Bauer, K., Volkers, P., Keller-Stanislawski. B Thiomersal and immunisations. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz (2004) 47: 1165-1174 Andus T, Stange EF, Höffler D, Keller-Stanislawski B Suspected cases of severe side effects after infliximab (Remicade) in. Med Klin (2003): 98:429-36 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 2002. Transfusion Medicine and Hemotherapy 2003, 30: 232-238 Keller-Stanislawski B, Hartmann K Auswertung der Meldungen von Verdachtsfällen auf Impfkomplikationen nach dem lnfektionsschutzgesetz. Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 2002, 45. 344354 Hartmann K, Keller-Stanislawski B Rekombinante Hepatitis-B- Impfstoffe und Verdachtsfälle unerwünschter Reaktionen. Bundesgesundheitsbi -Gesundheitsforsch-Gesundheitsschutz, 2002, 45. 355- 363 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, 1020-1028 Keller-Stanislawski B, Hartmann K Existiert ein Zusammenhang zwischen Impfungen und Typ-1-Diabtes mellitus bei Kindern und Jugendlichen? Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 2001, 44: 613-618 Hartmann K, Keller-Stanislawski B Verdachtsfälle unerwünschter Arzneimittelwirkungen (UAW) nach Anwendung von Impfstoffen mit attenuierter Masern- Komponente, Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 13/12/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 3 / 5 Curriculum vitae Brigitte Keller-Stanislawski 2001,44. 981-986 Lüderitz-Püchel U, Keller-Stanislawski B, Haustein D Neubewertung des Risikos von Test- und Therapieallergenen. BundesgesundheitsbiGesundheitsforsch-Gesundheitsschutz, 2001, 44. 709-718 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. 2000 Feb-Apr;22(1-2):69-70 Graul A, Keller-Stanislawski B Hämevigilanz von Blutprodukten. Bundesgesundheitsbi-Gesundheitsforsch-Gesundheitsschutz, 1999, 42: 143-149 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: 91-99. 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: 306-315 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, 31/10:476-482 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: 1160-1162. 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 (273-276). Keller-Stanislawski B, Marschner JP, Rietbrack N Pharmacokinetics of low-dose isosorbide dinitrate and metabolites after buccal or oral administration. Drug Research 1992,4271: 17-20. Keller-Stanislawski B, Osowski U, Rietbrack N Behandlung der chronischen Herzinsuffizienz. Wie bewährt sich Digitoxin in der Praxis? Therapiewoche, 1991, 41/27-28: 1803-1808 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: 92-95 Keller-Stanislawski B, Rietbrack N Bioavailability of two slow-release formulations of verapamil. Drug Research 1990, 40/10: 1086-1088. Projects Memberships Co-opted Member (scientific expert) of PRAC (Pharmacovigilance 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 (UAWAusschuss der AkdÄ) Member of the European Hemovigilance Network (EHN) Steering Committee Brighton Collaboration Vaccine Working Party of the CHMP 13/12/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 4 / 5 Curriculum vitae Brigitte Keller-Stanislawski Member of Global Advisory Committee on Vaccine Safety/WHO. PEI representative: German Standing Vaccination Committee (Ständige Impfkommission) Other Relevant Information 13/12/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 5 / 5
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