The panel discussion feature industry leaders discussing such questions as:

• If we believe there is a new emerging discipline of risk management, what are the core elements and other related disciplines that would comprise it?
• As new discipline emerges, how does it manifest itself across all stages of development and commercialization?
• What are some core scientific principles that could underpin the new discipline
• Since implementation and operation requires unprecedented multidisciplinary participation, where in organization should REMS implementation live and why?
• As this new discipline evolves, how would a new professional association be formed to set standards and credentials?
• How can/should professionals in this discipline shape FDA policy around REMS guidance?

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