Automation in Pharmacovigilance

 Automation in Pharmacovigilance

Pharmacovigilance(PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug associated problem.

Automation (robotization\computerization)describes the utility of wide range of technologies to monitor and control the production which reduce the human intervention process.

AUTOMATION IN PHARMACOVIGILANCE

In spite of variation in the PV processes from organization to organization, there are some activities like case processing, detection of signal, risk management, Adverse event (AE)reporting have to be addressed according to global requirements. Some of these processes create repetitive, manual tasks which frequently are not only time consuming but also extremely expensive for organization.

As one of the quickest developing life science disciplines, PV strategies ought to be optimized for top efficiency. Therefore, more organizations are realizing the powerful impact on the quality of work and the speed at which manual task can be accomplished.

Inducing advanced technologies like

• Artificial intelligence(AI)

• Robot process automation(RPA)

• Cognitive computing

• Cloud based solutions

• Mobile applications

• Technology for big data analyst

will assist organisations to obtain end-to-end automation through PV spectrum.

   Landscape of PV Automation

Life science corporations can understand higher effects through constructing AI into AE case processing(focused task such as case receipt, data verification&validation,duplicate check, case reporting,coding,triage ) with reliable data at their fingertips safety department work smarter and faster.

Automation can upgrade programmes with high quality and timely execution can realize several benefits with the application of an advanced safety case processing capability along with regulatory compliance which would be more economical and time saving process. Working with the deeper industry expertise will lead to the better the automation outcomes.

To make automation real,timely,useful and non-disruptive process there are 3 key areas which can be transferred through appropriate and effective use of technology. They include:

• Standardization and automation of PV approaches and protection data control is needed when technology solutions coupled with range of automation tools for downstream PV processing which leads to advantage efficiencies .

• Proactive PV and risk minimization is to identify & predict emerging safety signals which is possible by implementing data mining techniques.

• Fostering(promote) open and transparent data sharing through companies with regulators, prescribers and end customers can be made simple through application of progressive solutions to PV to become aware and distribute information automatically to investor.

Some examples like The US FDA Sentinel system, EMA’s EudraVigilance database & WEB-RADR is the indication of implementing tools that shows the full data transparency in industries.

  Roadmap of Automation in PV

Automation strategy eliminates the chances of human error however concurrently reduce costs thereby improving the quality and accuracy of safety data processing.

In identification of patterns in unstructured data and automating the whole process from case receipt to reporting automation is going to be a game changer.

Pharma Companies have traditionally been slow to adopt Technology in PV.It’s time for the technology to play a greater role in automation journey which impact the end-user in a positive manner.

By:-

Manisha Pagdalla

ClinoSol Student ID: 007/0121

J.Sai Keerthana

ClinoSol Student ID : 008/0121