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Xtalks, Online
2025-01-23
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.
Keywords: Pharmaceutical, Pharmaceutical Industry, Compounding Pharmacy, Pharmaceutical Marketing, Pharmacy, Risk-Based Monitoring, Risk Management, Regulatory, Risk Mitigation, Online Pharmacy
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Organized by:
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Xtalks |
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Invited Speakers:
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Justin Wilson, Executive Director, Global Risk Management & REMS Technology Lead, Syneos Health
Brent Weyers, Director, Global Risk Management & REMS Implementation, Syneos Health
Matt Wright, Director, Specialty Pharmacovigilance and Product Safety, CVS Specialty
Jeff Deitch, CEO, InfoWerks Data Services
J.W. Hill, MBAHCM, Executive Director, NCPDP Foundation
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Deadline for Abstracts:
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2025-01-23
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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