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Safety in Special Situations: Stem Cells, Vaccines, and Combination Products
Session Chair(s)
Arpad Simon, MD
VP Drug Safety and Pharmcovigilance, Relypsa, United States
This symposium will provide insights and guidance for signal detection and analysis of vaccines along with the challenges of having disproportionally-based signal detection methodologies. It will also include some of the factors to consider for stem cells and regenerative medicine and combination products.
Learning Objective : Discuss vaccine pharmacovigilance; Explain pharmacovigilance in special situations such as stem cells and combination products; Identify challenges of disproportionally- based signal detection methodologies in special situations.
Speaker(s)
Arpad Simon, MD
VP Drug Safety and Pharmcovigilance, Relypsa, United States
Safety and Stem Cells
Ajay Keshava, MS
Managing Consultant, WCI Consulting, United States
Requirements, Potential Approaches, and Challenges in Pharmacovigilance and Risk Management Practices for Combination Products
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