What Is the Future of Pharmacovigilance?

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What Is the Future of Pharmacovigilance?
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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• Agile Scientific is a life sciences organization
  that brings decades of industry knowledge,
  expertise, processes, best practices, and systems
  to companies. Agile Scientifics 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 CROs across all areas of Drug
  Safety, Regulatory Affairs, HEOR /
  Pharmacoepidemiology, Quality Assurance.