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Session 1: Welcome and Keynote: Integrated Risk Management Approach for Combination Products
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
What does it take to bring innovative combination products to market to advance public health? Why is the risk management paradigm so valuable throughout the lifecycle of these products to address the technical, clinical, and regulatory complexities of these products? Come here and engage with the CQO of Janssen, a leading combination products company, and the Associate Director for Policy from FDA's Office of Combination Products, as they discuss the critical importance of a comprehensive, structured, approach to development, assessment, and post market management of combination products, and the essential role of coordination and collaboration. Learn about the power of the risk management tool to enable such an approach, and the potential of risk management to drive adoption and implementation of sound practices, and application of consistent, predictable standards by sponsors and regulators alike. In addressing these issues, this keynote session will offer a framing for the value and content of the remainder of the conference.
Learning Objective : - Explain the benefits of creating an integrated risk management approach for combination products
- Discuss the importance of an integrated, structured approach to sound planning, decision-making and predictability of outcomes
- Discuss the need for coordination and collaboration across the product lifecycle and sound planning for engagement with regulators
Speaker(s)
Speaker
Robin Kumoluyi, MS
Janssen Pharmaceuticals, United States
VP & Chief Quality Officer, Pharmaceuticals
Speaker
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC