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AT Europe 2018: Roundtable Information
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Roundtable Sessions

 

Wednesday, 7 March 2018   17:05 – 18:05


Thursday, 8 March 2018       16:10 – 17:10

 

The Roundtable session will be a truly interactive workshop to connect and discuss real issues with your peers. These sessions were designed to be informal (but structured) discussions on topics which are of interest to participants. Participation will be on a first come, first serve basis. Each topic will include a facilitator, whose role is to help assist the discussion and ensure a lively exchange, and a scribe, whose role is to make general, anonymous notes about the discussion. Notes will be posted on this page two weeks after the conference.See below for a list of this year's topics.


               
 

Table 1: Mass Spec in QC

SESSION 1:
FACILITATOR: Carsten Jahn, AbbVie Deutschland GmbH & Co KG
SCRIBE: Katarzyna Kozakowski, MedImmune Limited

SESSION 2:
FACILITATOR: Hansjörg Toll, Sandoz Biopharmaceutical
SCRIBE: Simone Albrecht, Pfizer Ireland Pharmaceuticals

To view the table abstract and discussion notes, click here.

 

Table 2: Charge Variant Analysis (cIEF / IEC / CZE)

SESSION 1:
FACILITATOR: Cari Sänger - van de Griend, Kantisto BV
SCRIBE: Jerome Thiebaud, Sanofi Pasteur

SESSION 2:
FACILITATOR: Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices
SCRIBE: Katarzyna Kozakowski, MedImmune Limited

To view the table abstract and discussion notes, click here.

 

Table 3: Setting Specifications with Limited Batches and Analytics to Understand Process and Assay Variability

SESSION 1:
FACILITATOR: Harold Taylor, Merz Pharmaceuticals GmbH
SCRIBE: Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices

SESSION 2:
FACILITATOR: Cari Sänger - van de Griend, Kantisto BV
SCRIBE: Marta Germano, Janssen Infectious Diseases and Vaccines

To view the table abstract and discussion notes, click here.

 

Table 4: How to Translate Physicochemical Properties into Claims of Safety and Efficacy

SESSION 1:
FACILITATOR: Marta Germano, Janssen Infectious Diseases and Vaccines
SCRIBE: Hansjörg Toll, Sandoz Biopharmaceutical

SESSION 2:
FACILITATOR: Carl Jone, UCB Pharma SA
SCRIBE: Jennifer Römer, Aalen University

To view the table abstract and discussion notesclick here.

 

Table 5: Analysis of Polysorbate and Its Degradation Products

SESSION 1:
FACILITATOR: Friederike Junge, AbbVie Deutschland GmbH & Co KG
SCRIBE: Hilde van Hattum, Janssen Infectious Diseases and Vaccines

SESSION 2:
FACILITATOR: Anders Lund, Sanofi
SCRIBE: Pierre Guibal, Sanofi

To view the table abstract and discussion notes, click here.

   

Table 6: Phase Dependent Requirements for Method Validation Across the Globe

SESSION 1:
FACILITATOR: Francisca Maria Alberti Aguilo, Bayer
SCRIBE: Martin Pattky, HES-SO Valais

SESSION 2:
FACILITATOR: Elke Dietel, F. Hoffmann – La Roche AG
SCRIBE: Elisabeth Ruge, Roche Diagnostics GmbH

To view the table abstract and discussion notesclick here.

 

Table 7: Implementation of USP<129>

SESSION 1:
FACILITATOR: Carl Jone, UCB Pharma SA
SCRIBE: Elisabeth Ruge, F. Hoffmann – La Roche Ltd.

SESSION 2:
FACILITATOR: Christopher Jones, Retired from NIBSC
SCRIBE: Bert Wouters, Vrije Universiteit Amsterdam

To view the table abstract and discussion notes, click here.

   

Table 8: Automation

SESSION 1:
FACILITATOR: Mette Dahl Anderson, Novo Nordisk A/S
SCRIBE: Anders Lund, Sanofi

SESSION 2:
FACILITATOR: Harold Taylor, Merz Pharmaceuticals GmbH
SCRIBE: Francisca Maria Alberti Aguilo, Bayer

To view the table abstract and discussion notesclick here.

   

Table 9: Software Considerations for Methods Development and Data Evaluation

SESSION 1:
FACILITATOR: Simone Albrecht, Pfizer Ireland Pharmaceuticals
SCRIBE: András Guttman, University of Pannonia

SESSION 2:
FACILITATOR: Christof Finkler, F. Hoffmann – La Roche Ltd.
SCRIBE: Mette Dahl Anderson, Novo Nordisk A/S

To view the table abstract and discussion notes, click here.

 

Table 10: Control Strategy for Extractables and Leachables

SESSION 1:
FACILITATOR: Christian Bell, F. Hoffmann-La Roche Ltd.
SCRIBE: Rob Haselberg, Vrije Universiteit Amsterdam

SESSION 2:
FACILITATOR: Jason Wood, Bruker Daltonics, Inc.
SCRIBE: Bernd Moritz, F. Hoffmann-La Roche Ltd.

To view the table abstract and discussion notes, click here.

 


 

 

 

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