Correct seriousness assessment is critical in case processing as it impacts regulatory reporting and product safety. Below guidance must be followed while assessing seriousness criteria of events. Regulatory Definition of a Serious Adverse Event: Any untoward medical occurrence or effect that at any dose results in death, life-threatening, requires hospitalisation …
Multiple sclerosis: Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. Eventually, the disease can …
A duplicate case refers to the same individual case reported by different senders, through different routes to describe suspected adverse reaction(s) related to the administration of one or more medicinal products to an individual patient at a particular point of time. Common causes of duplicate reports are: A consumer and …
Hypoglycemia is defined as blood sugar levels dropping under 4.0 mmol/L which is lower than it should be. Hypoglycemia can be mild, moderate, or severe based on the person’s blood glucose and condition. Here are the levels: Level 1 (mild) hypoglycemia: Blood glucose is less than 70 mg/dL but is …
Clinical trials and pharmacovigilance are parallel processes, whenever any adverse event reported from the patient in trial it will be sent to pharmacovigilance team. Let us see in detail processing of how events experienced in trails gets submitted to regulatory authority. Who share information about adverse event to sponsor/pharmaceutical company? …
When a healthy volunteer/patient suffers a negative reaction to a drug an adverse event is reported and filed containing various data about the drug, its dose, its purported effect, patient health prior and after an adverse event, patient reaction to the drug prior and after adverse event among others. Sources …
WHO has been made aware of multiple, recent reports of eye injury, including blindness, with the use of chlorhexidine gluconate 7.1%, in nine countries in sub Saharan Africa. Chlorhexidine gluconate (CHX), available as an aqueous solution or as a gel (delivering 4% chlorhexidine), is used in umbilical cord care. WHO …
Once the received adverse event report confirmed as valid then further processing of case will start. Check below Individual case safety report (ICSR) process work flow to understand different teams involved in submitting report to regulatory authority and the major activities involved with each team. ICSR process work flow: Detailed …
Urinary tract infection: Urinary tract infections occur when bacteria enter and infect the urinary tract. UTIs can affect several parts of the urinary tract, but the most common type of UTI is a bladder infection (also known as cystitis). The body can sometimes fight the bacteria without any problems; however, …
Type 2 diabetes was previously seen only in middle age or older adults. However, with the rise of obesity in children, it is now being increasingly diagnosed in diagnosed in young people. Type 2 diabetes is a chronic disease in which the pancreas does not make enough insulin to control …