Viral Safety for Biologicals
18+ industry case studies on minimising viral contamination risk including new insights from Eli Lilly and Company, Merck Serono, Regeneron Pharmaceuticals and Novartis Pharma AG.
Independent analysis from Baxter BioScience on the application and implementation of next-generation detection technologies for rapid virus identification.
Genzyme and Sanofi Pasteur evaluate the implementation of upstream viral clearance barriers to reduce the risk of contamination from raw materials and media.
Roche Diagnostics present the first FDA approved viral clearance design space following QbD principles.
NEW interactive strategic panel discussions on dealing with pressure release during nanofiltration and strategies to handle suspected contaminations.
Critical regulatory advice from the FDA and PEI on the use of next-generation detection technologies, in-house data in viral clearance and viral safety standards expected.
Speaker and Presenter Information
Albert Stühler, Deputy Head of Virus Safety, Paul-Ehrlich Institut
Hayley M. Dingerdissen, Strategic Scientific Coordinator, HIVE, Center for Biologics Evaluation and Research, Food and Drug Administration
Mark Plavsic, Head of Product Biosafety, Genzyme a Sanofi Company
Christian Bell, Manager Development Recovery and DSP, Roche Diagnostics GmbH
Ivar J. Kljavin, Director, Global Biologics QC, Adventitious Agent Management, Genentech-Roche
and Many More!
Relevant Government Agencies
Dept of Health & Human Services
When
Tue-Wed, Jun 24-25, 2014, 8:30am - 5:00pm
Cost
| Full Pass: | £3687.81 |
Where
Hotel Pullman Cologne
14 Cologne Helenenstr
Cologne DE
Get directions
Website
Click here to visit event website
Organizer
Informa IIR Ltd
