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?
- Scientific data where possible and reasonable
- Judgements or decisions are reproducible and well-founded
- Risks identified and prioritized or rated by criticality
- Concentration on relevant risks
- 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?