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Date: 3rd - 5th June, 2008

Location: Berlin, Germany

Summary:
Pharmaceutical - Seminar

This international conference will create a platform for discussion about the latest regulatory guidances, critical issues and new technologies in virus and TSE safety. Representatives from European Health Authorities, FDA, technology providers and pharmaceutical industry will share their experiences and knowledge. Scientific and practical information will be presented. Special focus will be given to:

Virus Safety Forum

• Update on regulatory guidance for virus safety of biopharmaceuticals including plasma products: the European and the USA perspective
  
• Virus safety aspects of advanced therapies
  
• Testing for virus contamination; new methodologies
  
Virus removal technologies with focus on filtration and chromatographic procedures
• Use of in-house data for the virus safety assessment of investigational medicinal products
  
• Quality attributes of virus preparations used in virus reduction studies
  
• Risk management strategies
  

TSE Safety Forum

• Update on regulatory: the European and the USA perspective
  
• Experience of the industry with current regulations worldwide
  
• Infectivity up-date: blood, urine, tissues
  
• Prion spiking agents used in investigational studies
  
• Testing of blood: current status and regulatory/ethical problems