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.
Under the Accelerating Clinical Trials EU (ACT EU) initiative, the European medicines regulatory network regularly publishes statistics on the authorisation of clinical trials in the European Union (EU) and European Economic Area (EEA).
Instead of throwing money at new solutions, create a strong foundation to drive future value.
Observed versus expected (O/E) analyses have been used in an unprecedented scale for the safety monitoring of the COVID-19 mass vaccination.
And much more...
This guideline provides guidance for the development of medicines across all stages of Alzheimer's disease. It covers the impact of new diagnostic criteria for Alzheimer's, including early and even asymptomatic disease stages, factors to be considered when selecting parameters to measure clinical trial outcomes at the different disease stages in Alzheimer's, the potential use of biomarkers in the various stages of medicine development and the design and analysis of efficacy and safety studies.
Under the Accelerating Clinical Trials EU (ACT EU) initiative, the European medicines regulatory network regularly publishes statistics on the authorisation of clinical trials in the European Union (EU) and European Economic Area (EEA). This information provides an insight into how the Clinical Trials Regulation is transforming the clinical-trial environment in the EU / EEA.
The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
Instead of throwing money at new solutions, create a strong foundation to drive future value.
The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex.
The pharmaceutical industry stands at a transformative crossroads as artificial intelligence reshapes the landscape of drug development. In a Correspondence published in the KeAi journal Current Molecular Pharmacology, a group of researchers from China illuminate how large language models (LLMs) - the sophisticated AI systems powering advanced chatbots - are delivering unprecedented breakthroughs across the entire drug discovery pipeline.
Observed versus expected (O/E) analyses have been used in an unprecedented scale for the safety monitoring of the COVID-19 mass vaccination. The extent of their usage changed its nature, which consisted of a mixture of medical expertise and epidemiology, into something more algorithmic and automated.
The announcement of a 15% tariff on pharmaceutical imports to the U.S. from the EU may have not been the ideal backdrop for the busiest week of European pharma earnings this quarter, but CEOs appeared to be unfazed.
To date, signals of adverse reactions to herbal medicines have not been systematically reviewed, limiting pharmacovigilance of herbal medicines because of a lack of data.
Pictures used in this newsletter were generated by AI.