Vaccine Development and Approval: Phase 2 and Beyond

Venue: Loews Philadelphia Hotel

Location: Philadelphia,, Pennsylvania, United States

Event Date/Time: Nov 07, 2011 End Date/Time: Nov 08, 2011
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The unique demands of vaccine trials require discussion among all stakeholders with clarification of expectations and sharing of lessons learned. This conference will provide and opportunity to present key issues and case studies from industry and regulatory professionals on such topics as adaptive designs for vaccine trials, regulatory expectations, new pathways to approval and data challenges.

• Adaptive Designs for Phase 2/3 Vaccine Trials - Strengths and Weaknesses
• New Approaches to Approval: Licensure based on Immune Correlates
• Regulatory Challenges: Study Designs and Acceptance of Non-domestic Data

Target Audience:
Professionals involved in:
• Vaccine development and assay validation
• Clinical research
• Regulatory affairs
• CROs

Event Code: