Developing a Scientifically Guided, Risk-Based Virus Safety Concept for a Cell-Derived Vaccine

In Regulation and Policy by Freya SmaleLeave a Comment

vaccine safety, download, regulation

How should we regulate the development and production of vaccines? Tell us below!

Dr Jens-Peter Gregersen, Technology Development, Virus Safety and New Projects, Novartis Vaccines & Diagnostics joined us at the World Vaccine Congress earlier this year in Washington. To open, he began by asking: what is a scientifically guided, risk based concept?

Scientifically guided

  • Scientific data where possible and reasonable
  • Judgements or decisions are reproducible and well-founded

Risk-based

  • Risks identified and prioritized or rated by criticality
  • Concentration on relevant risks

Concept

  • Comprehensive
  • Forward-looking and proactive
  • The development of a viral safety concept has five stages, each of which is detailed within this presentation.

Why not download the full presentation and find out more about developing a scientifically guided, risk based viral safety concept for a cell-derived vaccine:

  • How do you get objective data for unknown contamination events?
  • How do you adequately assess the risks for hundreds of potential adventitious agent contaminants?
  • What are the limiting factors for virus inactivation and virus removal and how can they be overcome?

Download the full presentation here!

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