Live Online Conference: Endotoxin and Pyrogen Testing - Part of PharmaLab 2020
10-11 November 2020
Course No. 200034
Programme
Programme - 10 November 2020
09.00 - 09.30 h Introduction and Organisationals
09.30 - 10.15 h Key Note: Current European Pharmacopoeia Developments, with a Focus on Microbiology Dr Emmanuelle Charton, EDQM, Head of Divison B
10.15 – 10.45 h Break
10.45 – 11.15 h - Invention of rFC Speaker invited
11.15 – 11.45 h - Evaluation of rFC Speaker Boehringer Ingelheim invited
11.45 – 12.15 h - The Changing BET Landscape and the Recombinant Alternative Veronika Wills, Associates of Cape Cod.
12.15 – 12.45 h - Questions and Answers
12.45 – 13.45 h Break
13.45 – 14.15 h - Data as clean as Water: The Criticality of Detecting Relevant Endotoxins in Global Pharmaceutical Water Samples Nicola Reid, Charles River Laboratories
14.15 – 14.45 h - Symbols of Infection Kevin Williams, BioMerieux
14.45 – 15.15 h - Impact of Sample Preparation on Endotoxin Detection Speaker Invited
15.15 – 15.30 h Break
15.30 – 15.45 h - Masking of Endotoxin during Sample Hold Time René Ørving, Novo Nordisk
15.45 – 16.15 h - FDA's Thinking on Current Developments in Endotoxin and Pyrogen Testing Speaker FDA (invited)
16.15 – 17.00 h - Questions and Answers
Programme - 11 November 2020
09.00 - 09.45 h Key Note: RTRT: A Reality Check in the Small and Large Molecule World Dr Lorenz Liesum, F. Hoffmann-La Roche
09.45 – 10.30 h Overcoming Technical Issues with Assays to sssess Innate Immune Response Modulating Impurities Speaker FDA invited
10.30 – 11.00 h The Endotoxin Hypothesis of Neurodegeneration Professor Guy C. Brown, Department of Biochemistry, University of Cambridge
11.00 – 11.15 h Break
11.15 – 11.45 h Use of Monocyte Activation Test for Evaluation of Pyrogenicity associated with typical Environmental Contaminants Dr. Anja Fritsch, Confarma
11.45– 12.15 h Pyrogen Detection on Cellular Prepartions and other Short Shelf Life Pharmaceuticals Stefan Gärtner, Labor LS
12.15 – 12.45 h Questions and Answers
12.45 – 13.45 h Break
13.45 – 14.15 h Determination of Pyrogens from Medical Devices/MAT Multiplexing Dr Wolfgang Rudy, Tentamedix
14.15 – 14.45 h Using the Monocyte Activation Test to determine the Pyrogenicity of an OMV Vaccine Dr Marijke Molenaar-de Backer, Sanquin
14.45 – 15.15 h The Monocyte Activation Test (MAT): The Road forward for Pyrogen Testing Shabnam Solati, CTL-MAT
15.15 – 15.30 h Break
15.30 – 16.00 h Indutrials Experiences with MAT Speaker invited
16.00 – 16.30 h How to handle Endotoxin OOS, OOT and Atypic Results – the ECA Guide on Microbiologival Deviation Chapter 2 Jordi Iglesias, Charles River Laboratories
16.30 – 17.00 h Questions and Answers
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