Journal of Pediatric Neurological Disorders

Pharmacovigilance International

 Pharmacovigilance and drug safety remains a dynamic clinical and scientific discipline. As per the World Health Organization (WHO), Pharmacovigilance may be defined as ‘the science related to detection, assessment, understands and prevention of adverse effect or drug-related problems’. Pharmacovigilance plays an important role in choosing a good drug for the treatment. It also plays a vital role in ensuring that doctors, together with the patient, have enough information to make a decision when needed. Evidence comes to get those bigger adverse reactions which are very common, however many are preventable, disabilities, cause of illness and even death. The mechanism for monitoring and evaluating the safeties of medicine in clinical use are vital for preventing or reduce harm to the patient. Today, Pharmacovigilance is facing a lot of challenge i.e. globalization, web-based sales and information, broader safety concerns, monitoring of establishing a product, public health versus pharmaceutical industry economic growth and perceptions to benefit and harm, outcomes, and impact and many more. The issues like the unapproved or off-label drug use, problems with an orphan drug, and lack of pediatric formulation, as well as issues concerning with international clinical trials in paediatrics population, are concerned with the post-marketing surveillance. The basic Pharmacovigilance Process is shown in specify which methods and approaches can be adopted for Pharmacovigilance study. These regulations are much clear and more specific for the study. Most recommended PASS (PostAuthorization Safety Study) are more or less embedded in the guidelines. depicts Pharmacovigilance Methods as per ICH guidelines

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