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Showing posts from April, 2022

Good Pharmacovigilance Practice Guidelines

  This system, like all other systems, is defined by its processes, structures, and outcomes. The quality of this system can be defined by the characterized system that produces significant parameters based on the drug safety objectives for the sole purpose of good pharmacovigilance practices  that provide guidelines on the pharmacovigilance system's processes and structures. The quality structure includes the pharmacovigilance system's organisational structure, responsibilities, processes, procedures, and resources, along with resource management. All of this necessitates the completion of pharmacovigilance and clinical research training . Good Pharmacovigilance practice guidelines include:       All criteria based on patients, healthcare professionals, and public health must be met solely on the basis of safety.          All departments associated with the pharmacovigilance department should maintain an overall highly efficient and cooperative rapport.          All memb

Active Surveillance Method in Pharmacovigilance

 As active surveillance takes more time and money, it is employed less frequently in emergency situations. However, it is frequently more thorough than passive monitoring. It's typically used to keep track of case counts when an outbreak has started or is suspected. Community health workers may be instructed to aggressively discover cases in the community in order to identify individuals who do not seek care at medical institutions. To put it another way, it confirms a specific amount of adverse events through a continuous, pre-planned procedure. It's a way of ensuring that passive reports are representative and that health-related occurrences are reported more thoroughly. Hence, getting your clinical research training and certification can be a great investment in your professional future.  A) Sentinel Sites: 1) This entails gathering AE data on a subset of the overall population in order to gain insight into the wider population. For instance; to research about the various

Clinical Trial Recruitment

  A clinical trial is a study conducted on an individual for research purposes with the aim of assessing surgical, medical, or behavioural interventions. Clinical trials are the primary method used by researchers to determine whether a new treatment, drug, or diet is safe and effective for humans. In the clinical trial patient recruitment process, sponsors, sites, or  recruitment companies look for ways to join with patients who may be suitable for their trial. The advantage of contacting patients online or digitally is that you can reach them from anywhere in the world. Digital platforms facilitate contact establishment and encourage active participation in clinical research. Recent trends in clinical trial recruitment include increasing use of digital advertising to find the most suitable patients for the trial.Clinical research courses and  clinical research training is continually updated based on the disease and evolving technology to ensure the complete s

Importance of Pharmacovigilance

Pharmacovigilance is a wide term to explain drug safety. It explains the collection, safety, analysis, prevention, and monitoring of the ill-effects of drugs and therapies. It is a process-driven and methodical area within the pharmaceutical industry. This is a safety study of commercially accessible drugs that are tested under real-world conditions or in real-time clinical use in large communities. Pharmacovigilance aims to identify unknown safety problems as early as possible. It also aims to detect an increase in the frequency of these misbehavior's , to quantify the risks, and to avoid the patients from being affected unnecessarily.  Pharmacovigilance encourages education and clinical training by providing clinical research courses, pharmacovigilance courses, clinical research training etc.  Drug professionals' knowledge and awareness of a drug's safety profile plays a fundamental role in patient well-being. These professionals should be well aware of