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.
The safety signal assessment process evaluates the potential causal association between a medicinal product and a specific adverse event by integrating multiple streams of evidence. Existing causality assessment methods remain challenged by the considerable manual effort involved and by decision variability, even when drawing on the same underlying domains of evidence.
Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product’s benefit-risk profile. However, to date the practical application of risk minimization has proved challenging.
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and EISMEA’s Director Momchil Sabev signed a letter of intent to reinforce their continuing efforts in helping innovators better understand EU regulatory requirements and prepare health technologies for successful development.
And much more...
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and EISMEA’s Director Momchil Sabev signed a letter of intent to reinforce their continuing efforts in helping innovators better understand EU regulatory requirements and prepare health technologies for successful development.
EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their lives in poorer health. This disparity is due to societal aspects as well as gaps in disease prevention, diagnosis, and treatments, which do not always fully address the specific health needs of women.
EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available.
The safety signal assessment process evaluates the potential causal association between a medicinal product and a specific adverse event by integrating multiple streams of evidence. Existing causality assessment methods remain challenged by the considerable manual effort involved and by decision variability, even when drawing on the same underlying domains of evidence.
Developing new medicines can require thousands of chemistry experiments to identify the right recipe for a safe, effective and ideally affordable drug. The process is slow and labor-intensive, and many of the reactions depend on hard-to-source metals that act as essential catalysts.
Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.
Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product’s benefit-risk profile. However, to date the practical application of risk minimization has proved challenging.
Adverse drug reactions (ADRs) and their timely recognition are major patient safety concerns. Earlier detection of ADRs can improve outcomes through more timely medication management thereby minimizing harm.
Anti-spike monoclonal antibodies (mAbs) for early treatment of COVID-19 represented a significant improvement in the pharmacological management of the SARS-COV-2 pandemic, especially in early phases, but the continuous emergence of novel virus variants of concern (VoC) required a rapid and continuous benefit-risk assessment.
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