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.
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.
Who Should Attend?
This webinar will appeal to:
- Reps from pharmaceutical companies with REMS active programs
- Those with assets in development that may require a REMS for approval
- REMS Operations
- REMS Strategy
- REMS IT
- Head of PV
- Regulatory Affairs
- Legal
What You Will Learn
In this webinar, attendees will learn about:
- How REMS industry partners are collaborating to utilize health information technology standards to simplify REMS program implementations and reduce stakeholder burden
- What technology projects are underway to solve complex REMS challenges for prescribers and pharmacies
- How to prepare for the implementation of these innovative technology solutions
Xtalks Partner
Syneos Health®
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together they share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. They support a diverse, equitable and inclusive culture.
To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.
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