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Pharmacovigilance events in different regions cover common concerns

Posted on January 7th, 2016 by in Pharmacovigilance

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In December, Elsevier sponsored the 11th Annual Pharmacovigilance, Drug Safety and Risk Management conference in Brussels, Belgium and the 2nd Adverse Event Reporting and Safety Strategies Summit in Philadelphia, USA.  While these events took place in separate regions, the challenges reviewed at these conferences were remarkably consistent.

Key themes at these forums focused on social media, effective signal detection, and inspection readiness.  Some of the main takeaways from these conferences include:

  • There is no shortage of unknowns when it comes to social media. Social media presents a potential wealth of information that may not be available through other means, yet concerns remain about the capturing and validation of claims made in social media channels. Initiatives like Web-RADR were reviewed as potential methods of gathering drug safety information from patents, healthcare providers, and social media.
  • New methods are being used to identify signals. Several discussions focused on signal detection and interpretation — for example, understanding how bioinformatics and text mining approaches to identify signals compliments qualitative detection and signal validation.
  • Inspection readiness is a concern in light of regulatory changes. Conference participants discussed their experiences in dealing with uncertainties in the EU’s Good Pharmacovigilance Practices (GVP) regulations, shared best practices to understand the expectations of investigators and compared different approaches to implementing regulations.  In addition, it was acknowledged that inspection readiness is an enterprise-wide responsibility that extends beyond the Pharmacovigilance group.

It is clear that the evolving regulatory climate makes Pharmacovigilance and signal detection a global concern, and pharmaceutical companies worldwide share similar challenges when capturing adverse event data.  Whether in the US or Europe, pharma companies must contend with the growing list of information channels to be monitored, as well as navigate regulatory standards so they can be best prepared for inspections.  Fortunately, various tools and methods are emerging to help companies navigate the seemingly infinite sea of data so they can capture the most relevant information needed to optimize patient safety.

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