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1st International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Event

19 November 2018

Programme

Rapid Mycoplasma Testing - A revolution for Quality Control?
Prof. Renate Rosengarten, University of Veterinary Medicine Vienna

qPCR Mycoplasma Testing at Roche Pharma - method development, validation, and global roll out
Dr Alexander Bartes, Roche Diagnostics

External quality assessment of Mycoplasma NATs: regulatory implications
Dr Micha Nübling, Paul Ehrlich Institut

Case Study - Implementation of MycoTOOL as a Release Test
Damian Derincovsky, Novartis

Case Study - Approval of MycoTool Roche qPCR assay by FDA, FAMHP and MHRA, accelerating QC release of an autologous cell therapeutic product
Aurore de Lavareille, Celyad

Parallel Round Table Discussions in parallel

Table 1
MycoTOOL Q&A Session and experience exchange with the developer of the method (Roche Pharma)

Dr Sven Deutschmann and Dr Alexander Bartes, Roche Diagnostics

Table 2
Rapid Mycoplasma Testing for ATMPs

Jessica Wynendale and Kim Baert, Anacura
Aurore de Lavareille, Celyad

Table 3
Implement MycoTOOL on non-validated instrumentation (e.g. other PCR cycler)

Dr Manuela Natoli, Cancer Research UK
Dr Giusy Canino, Roche Diagnostics

Moderation

Dr Peter Steinhardt, Roche Diagnostics

Speakers

Dr Alexander Bartes, Roche Diagnostics
Senior QC Manager.

Damian Derincovsky,Novartis
QMS&T Facilitator BioProduction Operations Huningue, France.

Dr Sven M. Deutschmann, Roche
Head of ASAT Adventitious Agents Testing & Alternative Microbiological Methods, Global Analytical Science & Technology (gASAT), Global QC.

Aurore de Lavareille, Celyad, Belgium
QC Lab Supervisor.

Dr Micha Nübling, Paul-Ehrlich-Institut, Germany
Section Head Molecular Virology.

Dr Peter Steinhardt, Roche Diagnostics, Germany
International Alliance Manager, Business Development Pharma & Biotech, EMEA LATAM.

Prof. Dr Renate Rosengarten, University of Veterinary Medicine Vienna
Professor and Chair of Bacterioloy and Hygiene