Date(s) And Time(s):
Nov 7 2011 7:00AM - Nov 8 2011 3:00PM
Loews Philadelphia Hotel
1200 Market St
Philadelphia, PA 19107-3615
Address Issues and Challenges of Vaccine Development from Phase 2 to Licensure.
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
Professionals involved in:
• Vaccine development and assay validation
• Clinical research
• Regulatory affairs
Marjorie Davis, who can be reached by email at Marjorie.Davis@diahome.org, or by phone at 215-442-6176.