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Safety in Special Situations: Stem Cells, Vaccines, and Combination Products

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
411

Room Number:
1B

Level:
Intermediate

Type:
Symposium

Title:
Safety in Special Situations: Stem Cells, Vaccines, and Combination Products

Chair(s):
Arpad Simon, MD
Chief Medical Officer
Kyron Pharma Consulting, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Safety and Stem Cells
Arpad Simon, MD
Chief Medical Officer
Kyron Pharma Consulting, United States

Requirements, Potential Approaches, and Challenges in Pharmacovigilance and Risk Management Practices for Combination Products
Ajay Keshava, MS
Managing Consultant
WCI Consulting, United States