Biosimilars - Update on Legal, Regulatory and Technical Challenges of Subsequent Entry Biologics (SE

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Sep 29, 2008 End Date/Time: Sep 30, 2008
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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