Technology Innovation: Reducing Prescriber and Pharmacy Burden

Risk evaluation and mitigation strategy (REMS) programs were introduced as part of the 2007 FDA Administrations Amendment Act and may be used for certain drugs that have serious safety concerns to help ensure their benefits outweigh their risks.

If required, pharmaceutical companies must establish a REMS program by (1) agreeing to the goal and program requirements set by the US Food and Drug Administration (FDA), (2) establishing REMS implementation systems for stakeholders to conduct their required activities and (3) submitting REMS assessments to FDA.

REMS programs often require REMS stakeholders (Patients, Prescribers and Pharmacists) to complete transactions within the REMS implementation system to ensure that REMS activities have been fulfilled before the drug can be prescribed and/or dispensed. This activity is often performed outside of traditional healthcare workflow and systems, and therefore may increase stakeholder burden for participating in REMS programs.

Pharmaceutical companies, FDA and REMS industry partners have focused on addressing REMS stakeholder burden concerns through a variety of initiatives.

In this webinar, the expert speakers will examine the different REMS Health IT projects that are underway to address prescriber and pharmacy REMS stakeholder burden and look towards a more integrated, automated and aligned REMS implementation system approach.

Register for this webinar today to understand the evolving landscape of REMS programs and explore innovative health IT projects that are aimed at reducing the burden on prescribers and pharmacists.

Speakers

Justin Wilson, Executive Director, Global Risk Management & REMS Technology Lead, Syneos Health

Justin Wilson is an Executive Director of Software Development and Technology with over 20 years of experience in the healthcare industry, building innovative technologies to drive operational excellence and increase speed, efficiency and quality.

In his role at Syneos Health, Justin is leading the ongoing development of REMS’ end-to-end technology solutions, is responsible for overseeing strategic planning for the technology area of REMS, delivering the REMS programs and leading the internal and external vendors and partners in technology.

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Brent Weyers, Director, Global Risk Management & REMS Implementation, Syneos Health

Brent Weyers brings more than 15 years’ experience in technology, implementations and lifecycle support for Risk Evaluation and Mitigation Strategy (REMS) programs to his role on the Global Risk Management and REMS Implementation team at Syneos Health.

Prior to joining Syneos Health in 2021, Brent spent 11 years at McKesson, where he was largely responsible for providing client strategic oversight and support for multiple REMS and patient assistance programs.

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