Industry's premier event for optimising viral testing methods, minimising the risk of contaminatioin and satisfying strict regulatory requirments
5 Reasons to attend this conference
- Meet regulators from Germany and the UK and examine the important role platform technologies, in-house data and DOE can play in reducing viral validation studies
- Genzyme discusses the vesivirus contamination and the lessons learnt since the incident
- Novartis reveals how its manufacturing processes has been optimised to reduce adventitious agents
- Discover the best technologies, methods and approaches to detect and remove viruses
- Safeguard your products against the next wave of viruses threatening the industry
Highlights
Optimise your viral testing methods, minimise contamination and satisfy the regulators
- What do the European regulators think about the use of in-house data to support reduced viral clearance validation? read more
- Following the vesivirus contamination, what have Genzyme doen to minimise a repeat and what are the sentiments of the industry? read more
- What emerging viruses does my company need to be aware of? read more
- How can I adapt my manufacturing process to reduce adventitious agents? read more
Running Back-to-back with Transmissible Spongiform Encephalopathies - 10-11 June 2010
Speakers
- Dr Johannes Blümel, Paul-Ehrlich-Institut, Germany
- Dr Lucia Andreoni, Novartis Vaccines and Diagnostics Srl, Italy
- Dr Bolette Hellung Schønning, Novo Nordisk, Denmark
- Dr Michael Burdick, Talecris Biotherapeutics, USA
- Dr Joliette Coste, EFS Pyrénées-Méditerranée, France
Join the experts shaping the viral safety industry
Join the experts shaping the viral safety industry
Dr Sharon Longhurst
Pharmaceutical Assessor
MHRA, UK
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Greg Buczynski
Section Head, Viral Validation
Talecris, USA
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Albert Stuehler
Deputy Head of Virus Safety Section
Paul-Ehrlich Institut, Germany
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Mark Plasvic
Senior Director
Genzyme, USA
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Olga Galperina
Associate Director
Human Genome Sciences, USA
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Albrecht Groner
Head of Pathogen Safety
CSL Behring, Germany
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Jens-Peter Gregersen
Senior Management
Novartis Vaccines and Diagnostics, Germany
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Hannelore Wilkommen
Consultant
RBS, Germany
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Key topics covered
Day 1 - Tuesday 8 June 2010
- Platform Technologies
- In-House Data
- Regulatory Expectations
- Real-Life Regulatory Submissions
- Design of Experiments
- Recent Outbreaks
- Emerging Viruses
- Quality Attributes of Virus Spike Preperations
Day 2 - Wednesday 9 June 2010
- Viral Safety for Advanced Therapies
- Reducing Adventitious Agents by Optimising Processes
- Screening New Cell Substrates
- PCR
- Nanofiltration
- Viral Inactivation
- UVC,
- Lyophilisation
- Heat Treatment
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Make the most of your time out of the office and attend Informa's 7th Annual TSE conference, running back-to-back with Viral Safety. Industry's finest come from FDA, PEI and Novartis...plus many more!
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Pre-Conference Workshop - Monday 7 June 2010
Practical look at Viral/TSE Testing Requirements
Topics to be covered:
- Latest regulations
- Cell line characterisation
- Raw materials
- Virus reduction studies
- Reporting virus safety data in the IMPD
- Case studies
Reasons to attend:
- Delegates will gain a deeper understanding of:
- The principles of the virus safety assessment of IMPs
- The current requirements to demonstrate the safety of a cell line and to demonstrate the capacity of the process to clear viruses
- The appropriateness of raw materials for use in production and its documentation in the IMPD
Workshop leader:
- Dr Hannelore Willkommen, Regulatory Affairs & Biological Safety Consulting, Germany
Download Latest Information Now
(updated 1 September 2010)
Associate Sponsors
Feedback on 2010's programme
"Excellent coverage of state-of-the-art technology, regulatory and marketing opportunities"
"The program looks very good, we look forward to this event – Virusure, Austria"
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