返回 Agenda
Session 3: Pre-Market Stage of the Product Lifecycle
Session Chair(s)
Chin-Wei Soo, DrSc
Global Regulatory Head, PTR Devices and Combination Products
Genentech, A Member of the Roche Group, United States
An integrated and continuous application of risk management are crucial during development to ensure that combination products meet the intended use. This session will provide the audience with best practices to utilize risk analysis tools, quantify risk levels, implement mitigation approaches, and assess residual risks for drug-device combination products in an integrated manner.
Learning Objective : - Apply risk management best practices for drug-device combination products in an integrated manner
- Discuss the necessary risk management knowledge and skills needed to meet global regulatory requirements
Speaker(s)
Speaker
Molly Follette Story, PhD, MS
Sanofi , United States
Senior Advisor, Medical Device Development Unit
Speaker
Arlesa Hubbard, MS
Sanofi, United States
Global Head Quality Device Risk Management & Monitoring
Speaker
Phillip Robledo
Abbvie, United States
Associate Director, Regulatory Affairs