Wednesday, June 26 • 4:15pm - 5:30pm
#379: From Trials to Real World: How Safety Protocols Impact REMS

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-700-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Jamie Wilkins, PharmD


James Nickas, PharmD

Christine Brown, MS

Elaine Morrato, DrPH, MPH

avatar for Christine Brown

Christine Brown

Executive Director, National PKU Alliance
Christine Brown is the first Executive Director of the National PKU Alliance, a non-profit organization working to improve the lives of individuals with PKU and pursue a cure. Christine has more than 30 years of experience in building and leading non-profit organizations at the local... Read More →

James Nickas

Vice President, Pharmacovigilance and Clinical Medical Writing, Biomarin
James (Jim) Nickas is currently Vice President of Pharmacovigilance & Clinical Medical Writing at BioMarin in San Rafael, California. He joined the company in October 2010 bringing with him 12 years of academic experience at UCLA Medical Center and 18 years of drug development and... Read More →
avatar for Jamie Wilkins

Jamie Wilkins

Deputy Director, Division of Risk Management, OSE, CDER, FDA
Jamie Wilkins, Pharm.D. is the Deputy Director for the Division of Risk Management (DRISK) in the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA). DRISK provides risk management expertise on development... Read More →
avatar for Elaine Morrato

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health
Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA