Implementing a successful system of automating the process of pharmacovigilance
A growing number of medicines are now being launched annually, and the amount of product information that needs to be collated for regulatory purposes is increasing. Developing a successful system of automating the process of pharmacovigilance therefore has vital importance for any company involved in clinical trials or marketing pharmaceutical products. The pharmaceutical industry faces a range of challenges when it comes to PV systems. The regulatory environment is evolving and becoming more complex, which means that companies need to be smarter than before in order to keep up with regulations. The act of reporting adverse drug reactions is an important responsibility for all healthcare professionals. The vast amount of data that must be analysed and reported on a daily basis can sometimes seem overwhelming, but it provides the opportunity to learn more about medical treatments as well as improve patient safety.
Technology & Automation is the new Pharma
A vast majority of companies today are integrating various technological advancements into their pharmaceutical PV strategy as a means to help ensure clinical, safety and regulatory operations go smoothly for managing drug products in this day and age. With cloud-based solutions, mobile applications, robotic automation artificial intelligence (AI), big data analytics all becoming increasingly important parts of such an operation.
Automation can be a valuable tool for organisations looking to maximise efficiency. Automated systems, such as drug-related signal detection tools and risk management software, help these enterprises achieve new levels of quality in their work while freeing up vital resources that are better suited elsewhere. The increased accuracy found with automated solutions also helps them address the global nature of drugs' negative effects on society much more quickly than before!
There are a variety of automation tools that can help you through the process—from basic map-and-go solutions all the way up to robotic solutions with artificial intelligence features like natural language processing algorithms.
- Big Data Analytics
- Artificial Intelligence
- Machine Learning
- Robotic Process Automation (RPA)
- Natural Language Processing (NLP)
10 Key drivers for implementing an effective automated pharmacovigilance system.
There are a number of reasons for automating the process of pharmacovigilance and we've compiled a list below of the top 10 drivers we've seen in leading organisations that have automated the PV process to improve their efficiency and effectiveness.
- Automate-to get rid of manual tasks with the massive amounts of data that need to be generated and analysed day in day out, human error can occur when carrying out such manual tasks, PV automation can help reduce this and save time and resources.
- Automate-in order to Improve patient safety, by having systems in place that monitor for adverse events and automatically run checks to determine root cause of the adverse event, can identify errors in treatment and decrease patient safety risks.
- Automate-in order to handle the vast amounts of data that we now have available with systems such as electronic health records (EHR),unstructured data (EMR), structured data (PV databases) and clinical trials information generated on a daily basis, if not automated the process of data management would be a huge cost and waste of time.
- Automate-in order to meet the high regulatory requirements for PV reporting, by automating the PV process, organisations are able to stay on top of pharmacovigilance regulations as well as maintain strong compliance.
- Automate-in order to minimise the amount of time a PV analyst spends on writing reports, with the use of automated systems that allow real-time reporting, PV reports can be generated in a matter of minutes rather than hours or days that is the case with manual PV reporting.
- Automate-in order to give pharmaceutical companies increased visibility and reactivity to adverse drug events, allowing them to target risk areas more effectively and respond readily when problems arise.
- Automate-to predict the risk/benefit of a drug and respond quickly to signals that can identify problems before they occur.
- Automate-to increase the quality of data analysis by implementing automated systems to check for errors and inaccuracies such as duplicate entries, missing information and missing source documentation.
- Automate-provide Pharma companies with a more efficient solution for collecting and analysing safety data, by automating
- Automate-in order to create new markets by integrating new technologies into your organisation such as artificial intelligence (AI) and machine learning, big data analytics tools can help permit synthetic biology drug development from start up phase through from pre-clinical and clinical phases to market.
With the high stakes of pharmacovigilance, it’s important to have a system in place that will help you manage and continuously improve your process. The way pharmacovigilance can be done has been vastly improved by the help of automation, which can help in continuous data acquisition, detection of patterns, and identification of adverse effects. Automation also helps in aggregating data sets that are generated by disparate sources that would otherwise not have been possible through human interventions. The safety data generated through such automation is used by many stakeholders, including pharmaceutical companies, regulatory agencies and healthcare providers.
Thus, it has been suggested that the shift in pharmacovigilance activities towards automation has brought about increased efficiency, benefit and quality.
Whether it’s ensuring that your company complies with the latest regulations or developing new solutions to solve future challenges, Pharmacovigilance World Conference is here to provide insight and expertise on all aspects of drug safety. Come find out how we are transforming this space at our upcoming event!
Pharmacovigilance World 2021 (Virtual) - https://corvusglobalevents.com/conference/pharmacovigilance-world-2021
