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.
Why should you Attend:
In February of 2009 a new EMEA guidance document came into effect that addresses viral safety expectations for biopharmaceuticals used in European clinical trials. ICH Q5A, the ICH harmonized tripartite guideline on “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin”, outlines data that are needed for European marketing authorization, but does not specifically provide guidance for material used in clinical trials. The new document provides such criteria and defines the scope of the viral safety studies needed prior to and during clinical development. While some of the expectations in this document are current standard practice, there are also some new requirements. In addition, the document addresses the application of prior in-house data to a similar product.
This presentation will summarize the new EMEA Guideline document, noting the data that are typically provided and highlighting new expectations.Cell line qualification, testing of in-process material, viral clearance studies and risk assessments are all addressed.
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.
Who will benefit:
This webinar will provide valuable assistance to all biopharmaceutical companies that produce biological products from cell lines. Companies that manufacture human- or animal-derived products will also find this information useful. The employees who will benefit include:
- Process development scientists
- QA managers and personnel
- Regulatory personnel
- Consultants
- Upstream development scientists
Instructor Profile:
Kathryn Martin Remington, Ph.D. is the Senior Manager of Virology at Catalent Pharma Solutions, in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. She holds M.S. and Ph.D. degrees in Microbiology and has over 20 years of experience in virology. Before coming to industry, she worked in research studying drug resistant AIDS viruses. She was previously the Section Head of Viral Validation for Bayer HealthCare. Kathryn has been involved in the viral safety of biologics for over 12 years and is the author of number scientific publications on viral safety. She is a frequent speaker at conferences and workshops.
