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.
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports.
Drugs for rare diseases have played an increasingly significant role in the biopharma market for years.
Many high-stakes artificial intelligence (AI) applications target low-prevalence events, where apparent accuracy can conceal limited real-world value.
And much more...
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
Risk management plans (RMP) in post-authorisation phase: questions and answers
Post-authorisation measures: questions and answers
Many high-stakes artificial intelligence (AI) applications target low-prevalence events, where apparent accuracy can conceal limited real-world value. Relevant AI models range from expert-defined rules and traditional machine learning to generative large language models (LLMs) constrained for classification.
Industrial yeasts are a powerhouse of protein production, used to manufacture vaccines, biopharmaceuticals, and other useful compounds. In a new study, MIT chemical engineers have harnessed artificial intelligence to optimize the development of new protein manufacturing processes, which could reduce the overall costs of developing and manufacturing these drugs.
Early diagnosis of Alzheimer's disease (AD) and related dementias remains challenging because no single biomarker sufficiently captures the complex and multifactorial nature of the underlying pathology. In recent years, multimodal artificial intelligence (AI) models capable of integrating heterogeneous data sources—such as neuroimaging, fluid biomarkers, genetics, and cognitive assessments—have emerged as a promising strategy to improve early detection and risk stratification.
Drugs for rare diseases have played an increasingly significant role in the biopharma market for years.It’s clear from looking at the evolution of the data in that time that orphans offer considerable opportunity.
Medicinal product information documents (PIDs) detail clinical characteristics and instructions for monitoring, preventing, and mitigating adverse drug reactions (ADRs). They vary across countries, but there have been no recent international comparisons. We have therefore quantified and compared the completeness of the information given in drug labelling from different countries.
Although notable progress has been made in patient safety over the past 25 years, preventable harm continues to occur at an alarming rate. A 2022 U.S. Department of Health and Human Services (HHS) report suggests that approximately one in four patients may be harmed during hospital stays, and many of these events are preventable.
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