Referenten 2018

Beim PharmaLab-Kongress 2018 sind die folgenden Referenten dabei:

• Dr. Hans-Joachim Anders, Novartis Pharma Stein. Unitleiter Mikrobiologische Qualitätskontrolle. Mitglied der europäischen Expertenkommission für pharmazeutisches Wasser.
• Dr. Jan Amstrup, Novo Nordisk. Principal Scientist.
• Mathilde Arnault, Merk, France. Research Scientist - BioMonitoring R&D.
• Dr. Jürgen Balles, Labor LS. Managing Director.
• Dr. Alexander Bartes, Roche Diagnostics. Senior QC Manager.
• Petra Barth, formerly AbbVie. QA Trainer.
• Dr. Michael Bertz, Berlin Chemie. Leiter des Labors GC/AAS/ICP-MS in der Qualitätskontrolle.
• Ulla Bondegaard, Novo Nordisk. Currently responsible for maintaining cross-organisational (and cross-country) laboratory processes.
• Dr. Christopher Burgess, Burgess Analytical Consultancy, UK. Chairman of the ECA Analytical Quality Control Working Group. Qualified Person” in the EU. Member of the USP Expert Panel on Validation and Verification entrusted to revise General Chapters.
• Dr. Cornelia Bodinet, Schaper & Brümmer. Head of Division“ Pharmaceutical Laboratories”.
• Dieter Brillert, Wiewelhove. Head of Quality Control within Wiewelhove, a medium-sized CMO, focused on solid oral dosage forms.
• Dr Barbara Capecchiy, GSK. Senior Manager in Analytical Research and Development..
• Martine Caroff, LPS Bioscience. Analytical Project Manager
• Wilmar Correa, Research Center Borstel. Chief Scientific Officer.
• Sinead Cowman, Lonza. EU Business Development Manager – Informatics.
• Damian Derincovsky, Novartis. QMS&T Facilitator BioProduction Operations Huningue, France.
• Dr. Sven M. Deutschmann, Roche Diagnostics. Head of Global ASAT "Adventitious Agents Testing and Alternative Microbiologica. Chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology Interest Group”, Member of PDA Task Forces.
• Alexander Doppelreiter, VelaLabs. Head Quality Control.
• Silviya Dimitrova, TEVA Bulgaria. Member of the ECA QC Group Board and QP. Overall responsibility for quality oversight of European TEVA suppliers as well as QC and QP Release..
• John Dubczak, Charles River Laboratories. General Manager Microbioal Solutions Division.
• Julia Eichhorn, HHAC Labor Dr. Heusler. Qualitätssicherung für Validierungen, Stabilitäts- und Freigabeuntersuchungen, Kundenbetreuung.
• Dr. Ulrich Eikmanns, PharmaMedia Dr. Müller. Geschäftsleitung Vertrieb und Marketing.
• Dr Markus Fido, VelaLabs.. CEO and Founder of VelaLabs. Responsible for Finance & Controlling, Regulatory Affairs & Quality Operations.
• Dr. Anja Fritsch, Confarma. Responsible for cell based bioassays (development and routine).
• Carolin Frommn, Labor LS. Fachabteilungsleitung Prüfung auf Sterilität.
• Stefan Gärtner, Labor LS
• Dr. Wolf-Christian Gerstner, Geniu. Geschäftsführer.
• Barbara Gertent, Merck. Biomonitoring R&D Application Training Scientist. Mitglied im Advisory Board der ECA
  Pharmaceutical Microbiology Working Group.
• Dr. Eelo Gitz, Sanquin Reagents. Project manager product development.
• Florian Göhner, Vetter Pharma Fertigung. Projectmanager QC.
• Dr. Marcel Goverde, MGP. Geschäftsführer MGP. Vice Chair ECA Pharmaceutical Microbiology Working Group.
• Dr. Rainer Gnibl, Government of Upper Bavaria, Germany. GMP Inspector.
• Tina Grauwet, SGS Belgium. Business Unit Manager Pest Management Benelux.
• Stéphane Gumy, PMS Process Management System. General Manager & Contracted Qualified Person.
• Dr. Michael Haberl, Microcoat Biotechnologie. Director Quality Assurance.
• Jessica Hankins, U.S. Food and Drug Administration. Leads RMM implementation in ARD Eu for mycoplasma and endotoxin testing
• Rob Hahnraths, Bayer. IT Consultant - QA & Validation Services at Bayer. Co-lead of the GAMP® DACH Audit Trail review working group.
• Dr. Andrea Hauser, José Carreras Zentrum für somatische Zelltherapie. Head of Operations, Head of Production und Head of Quality Assurance. Qualified Person. Chair ECA ATMP Working Group.
• Dr. Alice Hellwig, Microcoat Biotechnologie. Director Laboratory Services.
• Dr. Ulrike Herbrand, Charles River Laboratories. Scientific Supervisor Bioassay R&D.
• Dr. Sunhee Hong, Charles River Laboratories. Microbial Solutions R&D Senior Staff Scientist.
• Dr. Hiltrud Horn, Horn Pharmaceutical Consulting. Managing director of HORN PHARMACEUTICAL CONSULTING with focus on CMC, GMP and Regulatory Affairs (EU and US).
• Dr. Juliane Hornung, Labor LS. Fachabteilungsleiterin Mikrobiologie/Zentraler Service.
• Dr. Gerd Jilge, Boehringer Ingelheim Pharma, Germany
  Quality Control. Member of the EDQM expert group 11 and Board Member of the ECA QC Group.
• Dr. Gerhard Karg, B.U.G.S. Managing Director.
• Yutaka Kikuchi, National Institute of Health Sciences.
• Sabrina Killat, Biologische Heilmittel Heel. Head of QC.
• Eberhard Kwiatkowski, PharmAdvantageIT. Berater für IT-Fragestellungen in der Pharmaindustrie. Mitglied des GAMP D-A-CH Forums und der APV-Fachgruppe „Computergestützte Systeme".
• Tejs Kyhl, ALK-Abelló. Senior Chemist, Laboratory Automation Development.
• Kyrillos Kyriosoglou, Roche Diagnostics. Chemical Engineer.
• Aurore de Lavareille, Celyad. QC Lab Supervisor.
• Dr. Laurent Leblanc, bioMerieux. Manager R&D..
• Philip Lienbacher, Shire. Globales Qualitätsmanagement. Leiter einer Abteilung von globalen System-Ownern und Projektmanagern.
• Dr. Lars Lueersen, CSL Behring Recombinant Facility AG. Senior Manager Chemical Quality Control und Global Tech Transfer PM.
• Marine Marius, Sanofi Pasteur. Scientist in Analytical R&D Microbiology.
• Jennifer Mayrhofer, VelaLabs. CPO Chief Project Officer.
• Dr. Michael J. Miller, Microbiology Consultants. Global expert in rapid methods, validation and pharmaceutical microbiology.
• Mirko Monti, Steriline.
• Dr. Christoph Mück, AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit. Quality Assessor für Biologische Arzneimittel.
• Dr. Danilo Neri, PQE. Validation Project Manager with expertise on Computer System Validation.
• Hans Noordergraaf, Abbott Biologicals. Global Microbiological Expert..
• Kai Nesemann, Sartorius Lab Instruments. Global Product Manager DNA-based rapid QC-testing.
• Dr Micha Nübling, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines. Section Head Molecular Virology.
• Dr Lucile Plourde Owobi, Sanofi Pasteur. Senior Scientist, Microbiology Global Analytical Science.
• Dr. Frank Panofen, Particle Measuring Systems. Product Line Manager Sterility Assurance & Microbiology.
• Dr. Jörg Peplies, Ribicon. Microbial quality control, computer validation.
• Dr. Christoph Prinz Apceth. Leiter QM.
• Dr. Jan Erik Rau, Lonza. Head of QC Microbiology.
• Christophe Riedel, Claranor. Business Management.
• Dr. Ruth Röder, Microcoat Biotechnologie. Project Manager Endotoxin Services.
• Prof. Dr. Renate Rosengarten, University of Veterinary Medicine Vienna. Professor and Chair of Bacterioloy and Hygiene.
• Margarita Sabater Dako Denmark, an Agilent Technologies Company. Manager Compliance Support at Dako. Board Member of the ECA QC Group.
• Dr. Heinz Sarter, Waldbrunn. Section Head Molecular Virology.
• Hartmut Schmidt,CSL Behring. Validierungskoordinator Validierung / Aseptische Prozesse
• Dr. Frank Sielaff, Regional Authority Darmstadt. GMP Inspector with focus on Inspection of drug manufacturers and laboratories in Germany and countries outside of the EU.
• Shabnam Solati, MAT BioTech. Co-founder and Lead scientist.
• Dr. Ingo Spreitzer, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines. Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.
• Andreas Steinle, Roche Diagnostics. Manager Digital Solutions in Pharma Technical Development Europe.
• Dr. Peter Steinhardt, Roche Diagnostics. International Alliance Manager, Business Development Pharma & Biotech, EMEA LATAM.
• Martin Tabak, Xendo. Consultant.
• Dr. Gabriele Wanninger, Leiterin des Sachgebiets Pharmazie..
• Klemens Weitenthaler VelaLabs. Technical Expert.
• Kevin Williams, BioMerieux.
• Veronika Wills, Associates of Cape Cod. Assistant Manager of Technical Services.
• Dr Friedrich von Wintzingerode. Roche Diagnostics. Senior Manager Microbiology, Head of Roche/Genentech global Endotoxin Expert Group and Roche/Genentech global SME on microbial product contaminations.
• Dr. Sebastian Ziewer-Arndts. analyticon instruments. Teamleiter Vertrieb. Beratung zum Themenschwerpunkt Einsatz NIR-, RAMAN und FT-IR Spektroskopie im Wareneingang, im Prozess und in der Endproduktkontrolle.
• Samuel Zürcher. Certus Molecular Diagnostics. CEO und Co-Founder.