Topics
- Risk factors associated with immunogenicity
- Self versus non-self
- How to use immunogenicity results from pre-clinical studies
- Regulatory expectations on immunogenicity testing
- Phase specific sampling plan
- Minimizing immunogenicity risk
- Case study and commercialization strategy
Who should Attend
Toxicologists, Pharmacologists, Project Managers, Clinicians, Consultants and Regulatory personnel from companies that are developing biopharmaceuticals that are NOT being used as vaccines.