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Conference Directory
Viral Safety for Biopharmaceuticals used in Clinical Trials
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Process development scientists,QA managers and personnel,Regulatory personnel,Consultants,Upstream development scientists
Start Date of Conference:: 12-01-2009
End Date of Conference: 12-01-2009
Description of Conference: This Viral Safety training/webinar will discuss the criteria and scope of viral safety studies needed prior and during clinical development as stated in new EMEA guidance document.
Learning Objectives:
For data to support European clinical trials:
Which viruses should be used for the viral clearance study?
How many steps should be evaluated for viral clearance?
Single or duplicate runs?
Are the viral assays adequate?
Does this new guidance document impact cell line characterization?
Can viral clearance data from a similar process be used to support a new product?
Areas Covered in the seminar:
Scope of viral clearance studies for clinical trial material to be used in Europe.
Cell line qualification.
Testing unprocessed bulk.
Use of in-house data.
Risk Assessments.
Opportunities to reduce the scope of viral studies.
Website
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