7 universal challenges facing drug safety

Drug safety, pharmacovigilance, benefit risk, inspection, signal detection


As always, the World Drug Safety Congress Americas a couple of weeks ago was a great place for people in the industry to discuss and debate topics of interest and look into alternative approaches to some familiar challenges and compare potential solutions.


Cognizant, provided a nice summary of some of the overarching challenges that we are all operating under.


The sources behind 7 industry challenges

  1. Inspections & scrutiny from regulators – we need to move beyond the reactive approach
  2. Broader global working – we need to be experts in the emerging markets
  3. Influx of information – new sources, social streams, new interactions and new ways that information is portrayed and processed
  4. Internal variability around processing – internal challenges in maintaining quality in light of overhead restrictions
  5. Data standards – collecting and building knowledge in your company
  6. New technologies – need to incorporate new technologies such as the cloud and analytics into the standard fabric of the company as other industries have done
  7. Multiple stakeholders – there are more stakeholders with more involvement in healthcare and pharma than ever before


A standard approach to these challenges familiar to many of us has been to throw manpower at the problem to overcome the hurdles. This has the potential to end up overstaffed with overly complex processes and using technologies inefficiently for processes outside of their original design.


So we all know the challenges, and that we need a more holistic approach. So what are the big game changers that we all need to be doing and involved in? There were 5 key areas highlighted where we need to be focussing to prepare for the future.


  1. Collaboration – Making the right partnering decisions at the right time
  2. Globalisation – This is more than cost cutting. Strive for better understanding and better working
  3. Transparency & trust – Between internal departments, and external partners
  4. Capacity monitoring – Better anticipate and simplify processes
  5. Information & analytics – What can we do better? Use the right tools and technologies for the right job


I thought this provided a nice broad overview of some of the familiar issues to many in the drug safety sector. The World Drug Safety Congress series of events delve into many of these themes in great detail with innovative content and interesting approaches. Take a look at the just released programme for the European event taking place in London this September.

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