Live Online Conference: Endotoxin and Pyrogen Testing - Part of PharmaLab 2020

10-11 November 2020

Course No 200034

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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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