Pathogen Safety Summit 2013
The effect of pathogen-contaminated medicines hits home when assessing the consequences of last year’s medically-induced meningitis outbreak in America. Over 60 people died and up to 14,000 were affected by fungal contamination of parenterals manufactured at the New England Compounding Center (NECC).
Mindful of this event, Pharma IQ’s 4th Annual Pathogen Safety Summit will allow you to implement practical strategies to avoid becoming the next NECC by:
- Ensuring quality in raw materials
- Applying rapid microbial testing methods and managing and interpreting the data obtained by next-generation sequencing
- Mitigating risk in the supply chain and during manufacturing
Following extensive discussions with biopharmaceutical and regulatory leaders, 16 industry speakers, 9 case studies and a panel discussion will sync to enable you to:
- Troubleshoot and discuss your challenges utilising new technologies with the FDA and MHRA
- Respond swiftly, effectively and decisively to identify and contain contamination in your manufacturing plant, and minimise operational disruption – interactive sessions with Bayer and Synthon
- Ensure quality when sourcing raw materials and replacing animal-derived media components – strategies from Genzyme and Virgin Health Bank
- Accelerate detection of Mycoplasma using qPCR and statistical tools – case study from MSD
- Perform cell line viral risk assessments in harmony with EU Annex 2 and ICH Q5A – key insights from Novartis
- Evaluate process economics for viral filtration using disposable technologies – case study from Rentschler Biotechnologie
NEW FOR 2013:An expanded programme encompassing quality assurance for Antibody, Vaccine, Gene and Cellular Therapies.
Plus TWO interactive workshops covering:
- Optimising adventitious agent detection with massively parallel sequencing
- Streamlining Mycoplasma prevention strategies and identifying effective monitoring processes
For full details of what this event has to offer, call +44 (0)20 7036 1300, email email@example.com or visit the website. Don’t miss out - reserve your place at the event before Friday 16th August and save up to €500!