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Referenten 2017

Beim PharmaLab-Kongress 2017 sind die folgenden Referenten dabei:

  • Dr. Peter Andersch, Wessling GmbH, Münster
    Technischer Leiter Laboratorien (Pharmaanalytik)
  • Dr. Karl-Heinz Bauer, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
    Leiter Quality Unit Metered-Dose- & Dry Powder Inhalation Products in Ingelheim
  • Dr. Julia Susanne Becker, Intertek AG, Schlieren, Schweiz
  • Ulla Bondegaard, Novo Nordisk, Bagsværd, Denmark
    Currently responsible for maintaining cross-organisational (and cross-country) laboratory processes.
  • Peter J. Boogaard, Industrial Lab Automation, The Netherlands
    Founder Industrial Lab Automation. Member of the ISPE GAMP community.
  • Peter Cornelis, Toxikon, Belgium
    R&D scientist and Business Analyst.
  • Dr. Ruth Daniels, Janssen, Belgium
    Senior Scientist, SME micro. Member of BPOG Low endotoxin recovery Group, and PDA Low endotoxin recovery task force.
  • Alexander Doppelreiter, VelaLabs GmbH Wien, Österreich
    Head Quality Control
  • Dr. Anja Fritsch, Confarma, France
    Responsible for cell based bioassays (development and routine).
  • Dr. Christian Flügge, Eurofins BioPharma Product Testing Hamburg
    Leiter Qualitätskontrolle
  • Dr. Wolf-Christian Gerstner, Geniu, Hamburg
    Managing Director
  • Dominic Hein, VelaLabs GmbH, Wien
    Analytical Project Manager
  • Dr. Ulrike Herbrand, Charles River Biopharmaceutical Services GmbH, Erkrath
    Scientific Supervisor für Forschung und Entwicklung
  • Anna Hertzog, Rentschler Biotechnology GmbH, Laupheim
    Analytische Projektmanagerin
  • Prof. Edwin van den Heuvel, University of Technology, Eindhoven, The Netherlands
    Professor at the TU/e department of Mathematics and Computer Science; professor Medical Statistics at the UMCG (University Medical Center Groningen).
  • Dr. Sunhee Hong, Charles River Microbial Solutions, USA
    Senior Staff Scientist. Responsible for curating the bacterial and protein coding gene sequence libraries for the Accugenix ID services.
  • Marleen Hoozemans, MSD, The Netherlands
    Associate Specialist. Currently working on the development of the Rapid Hybrid Mycoplasma Method.
  • Dr. Patricia Hughes, U.S. Food and Drug Administration
    Branch Chief (Actg), Division of Microbiology Assessment, OPF/ OPQ/ CDER.
  • Pieta IJzerman-Boon, MSD, the Netherlands
    Associate Director Quantitative Sciences/Center for Mathematical Sciences-Europe
  • Rick Jakober, Perritt Laboratories, Inc., USA
    Vice President Laboratory Services. Over 35 years experience in pharmaceutical microbiology, specializing in non-sterile products.
  • Niek Janssen, ALTRAN Netherlands
    Senior Consultant Life Sciences with strong background Computerised System Validation (CSV) and Industrial IT.
  • Dr. Sébastien Jouette, EDQM, Strasbourg, France
    Scientific programme officer in the Biological Division of the European Pharmacopoeia department.
  • Kham Nguyen, Rapid Micro Biosystems, USA
    Director of Sales.
  • Jan-Oliver Karo, Paul-Ehrlich-Institut – German Federal Institute for Vaccines and Biomedicines
    Associate Director Quantitative Sciences/Center for Mathematical Sciences-Europe
  • Dr. Melanie Kerst, HWI pharma services GmbH
    Head of Laboratory Services / Head of Business Development.
  • Robert Kopf, Hoffmann La Roche
    Laborleiter Biotech Analytics/Principal Scientist
  • Dr. Johannes Krämer, PHAST GmbH, Homburg
    Gründer und geschäftsführender Gesellschafter “PHAST Gruppe”.
  • Leo Leineweber, Technical Auditor/ Inspector, Münster, Germany
    Head of laboratory within the Official Medicines Control Laboratory (OMCL) located at the NRW Centre for Health of the federal state Nordrhein-Westfalen.
  • Philip Lienbacher, Shire, Wien, Österreich
    Globales Qualitätsmanagement
  • Dr. Lars Lueersen, CSL Behring Recombinant Facility AG Bern, Switzerland
    Senior Manager Chemical Quality Control und Global Tech Transfer PM.
  • Robert Lutskus, Lonza, USA
    Global Product Delivery Manager for MODA™ EM.
  • Eric De Maesschalck, UCB, Belgium
    Head of Global e-Analytics, Corporate Analytical Sciences.
  • Marine Marius, Sanofi Pasteur, France
    Leads RMM implementation in ARD Eu for mycoplasma and endotoxin testing
  • Mag. Christian Mayer, AGES, Wien
    Gutachter/Fachexperte für die Herstellung & Qualität von rekombinanten therapeutische Proteinen
  • Dr. Marcus Mreyen, Protagen Protein Services
    Director Business Development
  • Dr. Alexandra Müller-Scholz, Sartorius-Stedim-Biotech, Germany
    Scientist R&D Microbiology department
  • Dr. Hiroshi Nakano, CSL Behring Recombinant Facility AG, Lengnau, Schweiz
    Zuständig für die Erarbeitung und Einführung von vollständigen Laborautomationen in der Schweiz und Brasilien inklusive des kompletten Neuaufbau von Laboratorien.
  • Dr. Danilo Neri, PQE, Italy
    Validation Project Manager with expertise on Computer System Validation.
  • Dr. Andreas Nixdorf, SGS Life Science Services, Institut Fresenius,Taunusstein
    Für Projektmanagement und Kundenservice Pharma zuständig.
  • Dr. Karin Nordgren, National Institute of Standards and Control (NIBSC), United Kingdom
    Head of the Pyrogen Science Group, responsible for BET and MAT testing at the Institute, as well as maintaining established and developing new standards to support the area.
  • Dr. Ralph Nussbaum, SYNLAB pharma Institute, Aachen
    Leiter der Analytical Services.
  • Robert Porzio, Lonza, USA
    Global Product Manager. Focusing in instrumentation, automation and software solutions.
  • Dr. Jan Erik Rau, Lonza, Switzerland
    Senior Scientist and Lab-Manager.
  • Dr. Johannes Reich, MicroCoat Biotechnologie GmbH, Germany
    Focus on the aggregation and interaction of Lipopolysaccharides as well as the related activities in limulus based detection Systems.
  • Dr. Michael Rieth, Merck, Germany
    Department Global Regulatory Affairs
  • Dr. Ruth Röder, Microcoat GmbH
    Projektleiterin im Endotoxin Service.
  • Dr. David Roesti, Novartis Pharma Stein/USP, Switzerland
    Head of the RMM team and the Novartis Pharma expert network in microbiology.
  • Dr. Heike Schmidt-Eisenlohr, LPU Labor für Pharma- und Umweltanalytik GmbH, Hadern
    Stellvertretende Abteilungsleitung F&E mit Schwerpunkt E&L Studien.
  • Donald C. Singer, GSK/USP, USA
    GSK Senior Fellow / Biopharmaceutical GMP Ops at GSK. Vice-Chair of the USP Microbiology Committee of Experts.
  • Dr. Alicja Sobańtka, Octapharma Pharmazeutika Produktionsgesellschaft m.b.H., Wien
    Qualifikation von Materialien. Dies umfasst auch das Assessment von Leachables und die Planung und Supervision von entsprechenden E&L Studien.
  • Dr. Klára Sochorová, Sotioa.s., Czech Republic
    Working in cell therapy area. Particpates in the development from the scientific concept to the medicinal product used in phase III study.
  • Dr. Timo Söhner, HHAC Labor Dr. Heusler, Stutensee
    Zuständig für Methodentransfer und Validierungen.
  • Shabnam Solati, MAT Research, The Nederlands
    Biomolecular Researcher with 25 years of experience, and Monocyte Activation Test (MAT) specialist for over 11 years.
  • Dr. Ingo Spreitzer, Paul-Ehrlich-Institut, Germany Agency for Vaccines and Biomedicines
    Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.
  • Dr. Radhakrishna Tirumalai, USP, USA
    Global Principal Scientific Liaison-General Chapters in the Science Division. Liaison to the USP Expert Committee on Microbiology.
  • Dr. Ruud Vervoort, Waters, The Nederlands
    European Informatics Business Development Manager.
  • Dr. Astrid Visser, Sanquin Blood Supply Foundation, The Netherlands
    Coordinates the development of the MAT assay and cells for a robust, reliable assay
  • Tobias Voelkel, Sartorius Stedim Biotech, Göttingen
    Projektmanager - koordiniert Studien zur Validierung von Prozess- und Sterilfiltern sowie Untersuchungen zu Extractables/Leachables für pharmazeutische und biopharmazeutische Kunden.
  • Kevin Williams, BioMerieux, USA
    Author of the book “EndotoxinS 2”.
  • Dr. Friedrich von Wintzingerode, Roche Diagnostics GmbH
    Senior Manager Microbiology, Head of Roche/Genentech global Endotoxin Expert Group and Roche/Genentech global SME on microbial product contaminations.
  • Dr. Carl-Ulrich Zimmermann, Mycoplasma Biosafety Services, Vienna, Austria
    Head of Research and Development.