C4A – Risk Evaluation and Mitigation Strategies

May 8, 2019 @ 10:00 am – 11:00 am



By Gwendolyn Wise-Blackman

This webinar addresses development and implementation of a REMS to inform and train patients and caregivers of potential AE and to allow closer monitoring for AE.

Assessing the risk associated with new pharmaceutical entities or biologic compounds requires a detailed understanding of pathways involved in the therapeutic effect as well as the potential for interference with physiological processes for which the compound may have an impact.

Determining suitable monitoring strategies through testing and assessment of specific patient responses offers a mechanism for collection of data that can lead to advance warning of a potential AE.

Those working in patient care settings, patient monitoring, dispensing of pharmaceuticals or biologics, at-home care, and patient support service should consider attending this webinar to either become familiar with REMS, refresh knowledge, or receive updated information on implementation of REMS.

Attendees will receive knowledge on important and essential requirements related to REMS for potential pharmaceutical adverse effects.This webinar will provide basic understanding of requirements for REMS and offer steps to consider for implementation.

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