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Exhibitor Event/Non-CE: Case Study Spotlight
Session Chair(s)
Ricki Chase, MS
Vice President
Lachman Consultant Services, Inc., United States
Importance of Risk Management in Development of Combination Products
In her Case Study “Importance of Risk Management in Development of Combination Products”, Ricki Chase, former FDA Director of Investigations in the Chicago district and current Lachman Consultants Executive Director will discuss best practices and pitfalls in combination product development, focusing on a risk-based approach. Her presentation will cover risk management during combination product design and the importance of that focus at the interface between a pharmaceutical agent and the device component. She will discuss practical examples of situations in development of specific combination products where a robust risk-based approach was lacking and resulted in issues during approval at FDA that she has encountered while at FDA as well as observed in industry as a consultant. She will discuss how a proactive, risk-based focus among all members of the development cadre can speed combination products to market for use by patients in need. Please join us on October 13 to hear all about this.
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