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From Trials to Real World: How Safety Protocols Impact REMS
Session Chair(s)
Jamie Wilkins, PharmD
Head, Risk Management Center of Excellence
Pfizer Inc, United States
This forum will present the approach for evaluation of interventions and/or protocol amendments in trials, and how these interventions impact the determination of the need for a REMS, and its design. Presentation will use an approved REMS.
Learning Objective : Describe how safety interventions/trial protocol modifications are evaluated to ensure pre- and post-market continuity in safety management planning and the need for a REMS; Discuss evaluation of safety interventions in trials and their impact on REMS design; Discuss an example of the evaluation of trial protocol modifications and safety intervention considerations effecting an approved REMS.
Speaker(s)
Panelist
James Nickas, PharmD
Biomarin, United States
Group Vice President, Pharmacovigilance and Clinical Medical Writing
Panelist
Christine Brown, MS
National PKU Alliance, United States
Executive Director
Moderator
Elaine H Morrato, DrPH, MPH
Loyola University Chicago, United States
Founding Dean, Parkinson School of Health Sciences and Public Health
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