Biosimilars Event of the Year !

A Two Day Comprehensive & Interactive Conference with Case Studies and Discussions On:

- Health Canada Update on Regulations for Subsequent Entry Biologics (SEBs)
- Current FDA and US Legislative Developments on Follow-On Biologics
- EU Guidelines for Development and Approval of Biosimilars / Follow on Biologics
- SEB Regulations and Data Protection Regulations
- Analytical Determination of Equivalence for Biosimilars
- AnalyticalTechnologies for Protein Characterization
- Development of Similar Biological Medicinal Products Containing DNARecombinant Insulin
- Streamlining Formulation Development and Transfer to Production
- Manufacturing Strategies for Biosimilar Drug Substances
- Pharmacovigilance, post marketing surveillance
- Immunogenicity – clinical aspects, analytical methods
- Licensing and Authorized Generics in the US
- Branding, Pricing, Lifecycle Management
- Global Marketing Authorization
- Patents and Market Exclusivity
- Regulatory Requirements Updates on Clinical Studies for Biosimilars
- Genotropin/Omnitrope Biosimilar Controversy