Industry Insights: MedComms
This week’s round of insights draws on three articles from the winter edition of Medical Writing, a quarterly journal published by the European Medical Writers Association (EMWA). This edition focusses on the role of medical writers and communicators in keeping healthcare products safe.
Understanding complex pharmacovigilance safety reporting
Safety reports, such as development safety update reports and periodic safety update reports, remain essential to regulatory oversight throughout a product’s lifecycle. A recent article from Medical Writing on pharmacovigilance reporting outlined how medical writers can better author and manage complex submissions by combining regulatory knowledge with strong project leadership and interpretation of data sources. Strategies that the authors suggested that medical writers employ include clarifying stakeholder roles, establishing timelines, and using templates to support consistent outputs.
Article abstract: https://shorturl.at/u7d0s
Signal management: current and future practices
Signal management in pharmacovigilance is the process of detecting, assessing, and responding to new or changing safety concerns (also known as signals) for medicines. These signals are key to detecting a medicine’s benefit-risk profile. A recent EMWA review authored by Anastasia-Miruna Mihalache, senior medical writer, outlined how artificial intelligence tools can improve signal detection. The article also highlighted regulatory and ethical regulations as stepping stones to overcome toward implementing these tools in practice.
Article abstract: https://shorturl.at/cUWSA
How to help reduce medicine-related harm as a medical communicator?
Medicine-related harm remains a leading cause of avoidable patient injury, especially in older adults receiving many medicines daily. In her article, Rita Martins, clinical pharmacist, presented communications strategies that can help make healthcare and medicine use safer. According to Martins, these strategies primarily take into account patient experience and shared responsibility. Although generative AI (genAI) tools offer potential to improve pharmacovigilance and decision support, the author stressed that technology should strengthen but not replace human judgement.
Article abstract: https://shorturl.at/He9Pp
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