Importance of Pharmacovigilance during a pandemic
Pharmacovigilance can be simply defined as the intense supervision and monitoring of a drug or drug related products during its clinical trials and thereafter its launch to the market. Pharma comes from a Greek word Pharmakeia which means drugs, medicines, or remedies and vigilance from Vigilantia, meaning wakefulness, watchfulness, and attention. So the pharmacovigilance team has the most responsible duty of monitoring, investigating, and communicating any adverse drug reactions associated with any medicinal products thereby evaluating the risk-benefit ratio of the product.
It is high time to rewind the tactic being taken by the health care industry towards pharmacovigilance as Covid has become the new reality for the health care system and manufacturing company as they are the front runners in fighting against this deadly virus. Regulatory agencies around the world are evaluating the impact of the virus, the various phases of clinical trials, and post marketing surveillance .The rapidly changing situation with the outbreak of the virus has compelled agencies to be more vigilant and proactive in determining effective surveillance program to reduce the hardships of patients suffering from this viral attack and to provide a better patient care.
As we are sailing through this critical situation of covid pandemic, the need of pharmacovigilance is crucial to ensure patient safety and also to protect the reputation, good will and trust of pharma companies. For a new drug to reach the consumer market, it has to pass through different phases of clinical trials and need tireless efforts and time of researchers to complete the journey of drug from its origin in the lab to its introduction into the public. But during any pandemic situation like this Covid scenario the outmoded drug approval process is not advisable and is highly recommended to bring the emergency NDA process to get market authorisation as we don’t have any effective treatment available to fight against the new strains of this corona virus. Hence the vigilant system to monitor the safety and efficacy of new therapeutics or vaccines should be more stringent and efficient to avoid further complications and worsening the hardships of patients suffering from this viral infections.
While multiple therapeutics are under developments and vaccines of many big pharmaceutical companies are heading to phase three clinical trials, the health care industries have an eye to always improving the safety of patient care. The recent updates in the development of Covid vaccine reveals that two vaccines are already authorized and recommended by our government and are currently available to the public. Since no existing therapeutics or vaccines are available and these newly developed vaccines are entirely new to the market, the function of a proper pharmacovigilance team is mandatory for patient safety and to avoid their further sufferings.
Since huge amount of data is involved in pharmacovigilance activities, and the data sources used to identify adverse events like reports from patients and healthcare practitioners, safety databases, electronic health records, clinical trial data, scientific literature etc. requires significant manual effort. The pandemic emphasises how advanced data analysing technology and cognitive technologies like Artificial Intelligence, machine learning and natural language processing will radically improve the pharmacovigilance functioning and thereby playing a pivotal role in the success of public health programs throughout the world. But we are actually unable to meet the demand of the industry as we are lacking man power in this field. The demand- supply ratio of skilled professionals in this pharmacovigilance department is not meeting its actual requirement.
To overcome this challenge we need to fill the gap by providing technically skilled professionals to this field. For this we need reputed training institutes and well trained professionals to impart training in pharmacovigilance field to students who are qualified to become a part of this industry. Avigna clinical research institute of Bangalore is the pioneer in the field of clinical research and is equipped with all the resources to provide Pharmacovigilance course online and we do offer ELearning pharmacovigilance course with easy learning modules and updated syllabus to meet all industry requirements.
Our Pharmacovigilance certificate course online will enable the students to access our curriculum sitting at their own home. Though many institutions are offering different online pharmacovigilance training & courses, what makes us different from others is the practical experience they get on the simulating software developed in-house. Our software training along with the PV module will make our students different and standalone among others.…
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