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.
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling. A clinical trial of Epidiolex®, the only US FDA-approved cannabis-derived consumer product (CDP), discovered an interaction with an immunosuppressant (tacrolimus) that led to drug toxicity,. Artificial intelligence is increasingly being used in pharmacovigilance. And much more...
European Medicines Agency’s data protection notice for EudraVigilance Human (EV)
Harnessing AI in medicines regulation: use of large language models (LLMs).
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
Artificial intelligence is increasingly being used in pharmacovigilance. However, the use of artificial intelligence in pharmacovigilance raises ethical concerns related to fairness, non-discrimination, compliance, and responsibility as the central ethical principles in risk assessment and regulatory requirements.
To safely realize the clinical benefits of LLMs, we need a regulatory approach as innovative as the technology itself.
conversation with experts from Accenture on making the most of LLMs.
A clinical trial of Epidiolex®, the only US FDA-approved cannabis-derived consumer product (CDP), discovered an interaction with an immunosuppressant (tacrolimus) that led to drug toxicity, highlighting the unique intersection of prescription and commonly unregulated consumer products.
While medication errors (MEs) have been studied in the European Medicines Agency’s EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted.
A new study from King's College London shows that off-label prescriptions of a common antidepressant doesn't help breathlessness in patients with respiratory disease - and may cause side effects.
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