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| Begins |
September 29, 2008
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| Email |
enquiry@ipacanada.com
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| Category |
Science: Biology
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| Category 2 |
Science: Biotechnology
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| Category 3 |
Health: Medicine
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| Description |
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
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