en
10.06.2022

Modern Automation Risk Management in Aviation – Know- How for the Pharmaceutical Industry

Dr. Jan Petracek is driven by finding ways to advance pharmacovigilance systems for the better good of patients, organizations, health authorities and all other concerned members of society.  And, at the same time, he is very interested in airplanes and becoming an expert pilot.  He has already presented an intriguing presentation at last year's ISoP conference, more details here.  And below are details on an abstract that has just recently been submitted to an upcoming future event.  If you are interested in airplanes and PV, you will enjoy Jan's thoughts and analysis.

Learning Objectives:


1. Learn the know-how of automation risk management from a well-established high-risk industry 

2. Apply these innovative and proven approaches in your risk management practice in pharmacovigilance 

3. Avoid repeating fatal mistakes observed in aviation while you implement your pharmacovigilance automation

Summary:


A highly regulated and complex environment where lives are at stake is the Aviation Industry. With most of the workload automated, the high-risk Aviation Industry has developed robust risk management systems directly applicable to pharmacovigilance

Presented by a pilot and pharmacovigilance expert, surprisingly relevant lessons from the aviation industry automation journey for the pharmacovigilance automation journey have been identified. Six generations of Crew Resource Management have seen remarkable approaches to risk management thinking.


  • The First primitive paradigm that safety was a function of flight-crew performance exclusively led to an extensive blame game for all errors and was unable to address real issues. Some pharmacovigilance systems may still work at this level. 
  • The Second generation included interactions between players and developed the first decision making models. This is where most developed pharmacovigilance systems currently are. 
  • The Third generation added cognitive dimensions and human-machine interactions, stress and fatigue management, management of automation, vigilance, and human reliability. This is the maturity level we are entering now within most pharmacovigilance systems. 
  • The Fourth generation included elements of Company Resource Management, Organizational Resource Management, including service quality, job satisfaction and cost efficiency, and LOSA – Line Operation Safety Audits. It acknowledges the fact that human errors, as well as technology errors are inevitable, and therefore risk management must be applied routinely. Many pharmacovigilance systems have included some, but not all of these useful concepts as of yet.
  • The Fifth and Sixth generation developed advanced error management and TEM – threat and error management. Extremely useful for design of pharmacovigilance system, as well as for management of medication errors, combination products and medical devices. By automation, we can decrease the number of people needed for the task. However, it goes hand in hand with increasing demands on the team. Performance triangle is a key tool to set the right balance between design, procedures, competences, and system performance in a given environment.

To connect with Jan an to stay current with all that he is involved with, we would encourage you to visit his LinkedIn page or to contact iVigee directly here.

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