What Is the Future of Pharmacovigilance?

1. What Is the Future of Pharmacovigilance?

2. With the regulatory environment changing almost daily, the challenges of maintaining complex pharmacovigilance systems, is becoming increasingly tough, and the future of PV is set to rely upon AI and other automaton tools. Not only are the public becoming more aware of the issues surrounding pharmacovigilance, but with the frequent use of social media platforms, and intense scrutiny from the media, companies involved in the pharmaceutical industry need to act more diligently than ever before. The need to rethink PV strategies: With the introduction of AI and other PV automaton tools, technology solutions that already exist, such as safety databases, must work alongside more modern, innovative methods in order to be successful.

3. How regulatory authorities are using modern tech: Collecting and evaluating adverse events for therapies is already underway by many regulatory authorities, with the use of the U.S. FDA Sentinel System, for example: and electronic system used to monitor the safety of medical products available on the market today, and which works alongside the FDA Adverse Event Reporting System, or FAERS. There are also apps for mobile devices that enable users to report adverse drug reactions to the relevant authorities.

4. Improving end-to-end safety processes: In order for PV systems to be truly effective, the people managing the system must be properly trained, and the system itself must be able to receive and manage data from global sources while delivering automaton efficiencies. End-to-end safety processes must be made more effective, and the first step to achieving this process mapping to encourage and drive forward improvements. How to achieve full pharmacovigilance transformation: Involving many levels of automation, the basic procedure for automating a process workflow involves the tracking and monitoring of tasks with the collection of continuous metrics.

5. Resulting in automatic entry, processing and analysis in a safety database, robotic process automation, or RPA, can help to significantly reduce manual tasks. Often combined with RPA, natural language processing can help humans to make more informed decisions, and cognitive computing has humans at its heart, driving the decisions that provide the required outcome. This is in contrast to AI, which naturally involves little, or no human interaction. Machine learning and pharmacovigilance: A subset of AI, machine learning allows analyst and data scientists to build algorithms that, based upon data, can learn and make effective predictions. Trained to identify patterns in big data, the algorithms improve over time.

6. Automation is expected to have significant benefits for PV, such as improved regulatory compliance and enhanced productivity, among others. The future of pharmacovigilance: With the effective use of the appropriate technology, the following 3 safety areas can be significantly improved upon: Efficiency, quality and compliance can be enhanced with the standardization and automation of PV processes and safety data management.

7. Through the mining of data, emerging safety signals can be better identified and predicted. AI gives a much clearer view of safety issues, while advanced cognitive solutions extract code and process AE data for greater transparency and trust. Building a roadmap for the successful future of pharmacovigilance: ● ● ● A clear vision, robust strategies, milestone initiatives and strong partners with proven track records in PV delivery, safety technology and regulatory reporting, are essential elements for any pharmaceutical company wanting to guarantee the success of PV for the future.

8. Making efficient and proper use of such technologies as mobile apps tech for big data analytics and cloud-based solutions, are set to help companies progress towards end-to-end automation right across the spectrum of pharmacovigilance. For all companies wanting to meet the many and varied challenges that PV throws at them daily, and to ensure that they can play a role in its future, they must embrace advanced technology solutions and automation.

9. Agile Scientific is a life sciences organization that brings decades of industry knowledge, expertise, processes, best practices, and systems to companies. Agile Scientific’s clinical services function to accelerate all facets of drug development, ensure compliance at a global level and optimize pipeline value / ROI. Agile Scientific Group LLC is fortunate to partner with smaller virtual organizations and Fortune 500 Life Sciences companies alike. We have extensive experience providing focused, pragmatic clinical solutions to our sponsor Life Science organizations and CRO’s across all areas of Drug Safety, Regulatory Affairs, HEOR / Pharmacoepidemiology, Quality Assurance.