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| Pharmacovigilance |
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Different countries and regions witness varied patterns in drug effects and reactions. This occurs due to differences in diseases, genetics, diet, prescribing practice, local traditions and drug manufacturing process impacting its quality, amongst others. Pharmacovigilance is practised to ensure the quality of medicines is maintained and to safeguard public interest to prevent any harm to patients.
Hence through pharmacovigilance we are able to improve patient care, safety and public health, whilst ensuring a rational and effective use of medicines and therefore also providing cost benefits through use of the medicines. In addition, through this process we are able to encourage better understanding and clinical training, and educate the public on key aspects in medicine.
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Ecron Acunova Expertise
Pharmacovigilance consists of analysing the effect of medicines and their impact on human beings. In this process, as pharmacovigilance service providers, at Ecron Acunova we assess information collected from patients and healthcare providers in order to learn about the adverse effect of medicines and ensure that we are able to prevent any harm to patients.
Hence, we undertake periodic safety update reports, prepare literature reviews and medical narratives, conduct CIOMS on the web, regular medical monitoring and undertake ongoing signal detection as well as trend analysis.
Broadly categorised, our services encompass safety management, regulatory reporting, and post-marketing surveillance, as well as technology support. Our team consists of dedicated, skilled, and experienced physicians, life science professionals, and other clinical professionals experienced in drug safety. |
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Pharmacovigilance worldwide
Pharmacovigilance efforts are undertaken on a global level through specialised agencies in different regions. For example, in Europe, these efforts are co-ordinated by EMA (European Medicines Agency) and the NCA (National Competent Medicine Authority). By developing and maintaining a database of adverse reactions to medicines in Europe, these agencies ensure the public at large is adequately protected. This database is maintained based on the submissions by individual drug companies. In the US, the FDA is responsible for co-ordinating these efforts. In India, the pharmacovigilance efforts are in progress as instituted by the DCGI, but are still in their infancy. The challenges in standardising processes for pharmacovigilance is still being ascertained and conceptualised. |
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