ArticleTherapeutic innovation & regulatory science2025
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Digitalizing Risk Minimization Measures in EU: Explorative Co-design Workshops with Expert Stakeholders.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
'Risk Management Plan Educational Materials' (RMP EMs) are additional risk minimization measures (aRMMs) intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient. While the healthcare sector is embracing various digital tools and platforms for educational and/or awareness building purposes, paper-based materials have remained the mainstay approach for implementation of aRMMs by pharmaceutical companies. Novartis in Singapore conducted a pilot on the feasibility of distributing electronic copies of RMP EMs (e-RMP). Post-pilot, e-RMP was officially implemented in Novartis Singapore. A year following the launch of e-RMP, a survey was performed with healthcare professionals (HCPs) to understand end-users' experience. The survey responses revealed a general preference by both HCPs and patients towards e-RMP. Digital methods of delivering educational aRMMs offer great benefits over traditional paper-based programs. e-RMP significantly reduces the time needed for updated RMP EMs to reach HCPs and their patients/caregivers. This is important to ensure that HCPs and patients/caregivers are made aware of any updates in key safety messages of the products in a timely manner to ultimately ensure patient safety. The successful transition to digital solutions requires purposeful collaborations between key stakeholders of the healthcare ecosystem including regulatory authorities, pharmaceutical companies, HCPs, patients and caregivers. This article aims to provide insights on the digitalization journey of e-RMP, a case study in Singapore, outlining the value but also some of the challenges faced during this transformation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.