Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Artificial intelligence (AI) is increasingly being explored to support pharmacovigilance activities including processes involving individual case safety reports. These technologies may improve efficiency and enable new analytical capabilities, but they also raise important questions regarding the responsible use of these systems in contexts that directly support regulatory decision-making and patient safety.
AI can automate hours of work each week, but it also requires substantial human oversight. Leaders need to account for that hidden labor.
EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO).
And much more...
EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
This Data Protection Notice explains the most essential details of the processing of personal data by the European Medicines Agency (hereinafter 'EMA' or 'Agency') in the context of the collection and categorisation of responses to questionnaires in the 360° assessment exercise for managers.
Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European Medicines Regulatory Network (EMRN comprised of EMA and Member State National Competent Authorities). Since 2016, the EMRN, has been monitoring and managing medicine availability issues, including supply chain disruptions, to improve the continuity of supply of human and veterinary medicines across Europe.
Artificial intelligence (AI) is increasingly being explored to support pharmacovigilance activities including processes involving individual case safety reports. These technologies may improve efficiency and enable new analytical capabilities, but they also raise important questions regarding the responsible use of these systems in contexts that directly support regulatory decision-making and patient safety.
While multimodal survival prediction models are increasingly accurate, their complexity often reduces interpretability, limiting insight into how different data sources influence predictions.
Pharmacovigilance is essential to ensuring patient safety by enabling timely identification of adverse reactions in increasingly complex and voluminous data. Routine quantitative signal detection methods generate statistical alerts for product-event pairs based on predefined criteria; however, most alerts do not warrant further investigation, creating inefficiencies and significant time demands for pharmacovigilance teams.
Our Management Tip of the Day newsletter continues to be one of HBR’s most popular newsletters. In this article, we’ve compiled 10 of our favorite tips on learning from failure, from how to apologize to a customer to how to get your team back on track when a project is failing.
AI can automate hours of work each week, but it also requires substantial human oversight. Leaders need to account for that hidden labor
Sometimes, work that requires effort leads to scarcity, and that scarcity can increase its value. But not always.
Pictures used in this newsletter were generated by AI.