Referenten 2017

Beim PharmaLab-Kongress 2017 waren 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
• Christophe Girardey, wega Informatik AG, Switzerland
  Christophe Girardey manages the group CSV & QA at Wega Informatik. He is involved in different Lab Systems Projects (Lab Execution System, LIMS, …) as Validation Lead or Business Analyst accross Switzerland and Germany.
• 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
• Kai Nesemann, Sartorius Lab Instruments GmbH, Germany
  Junior Product Manager Microbiology. Focus: DNA-based rapid microbe detection methods in microbiological quality control; microbial cultivation media.
• 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.
• Matthew Paquette, Charles River Laboratories, USA
  Product- and Technical Specialist.
• 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, GBA PHARMA 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. 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.