The RMO & Partners Podcast

(GenAI) ABPI January 2025 Cases Unpacked: Lessons for Compliance & Ethics teams


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This podcast episode provides a deep dive into recent PMCPA rulings relevant to pharmaceutical promotional practices in the UK, offering practical lessons for compliance officers. It examines case studies involving complaints against Roche regarding Vabysmo and AstraZeneca concerning Trixeo. The discussion highlights the importance of understanding how the PMCPA interprets the code, particularly in relation to implied claims and the presentation of data. Key topics explored include the significance of context in assessing the accuracy and potential for misleading interpretations of promotional materials, the need for clinical evidence to support claims of benefit beyond a drug's mechanism of action, and the careful presentation of clinical trial data, especially mortality endpoints and statistical significance. The podcast also touches upon the role of internal review processes, the importance of a culture of compliance, and the impact of external scrutiny from regulatory bodies like the FDA.


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The RMO & Partners PodcastBy RMO & Partners