European Pharmacovigilance & Risk Management: 6 Industry Trends to Monitor

European Pharmacovigilance & Risk Management: 6 Industry Trends to Monitor

This week, I had the privilege of chairing the 4th Annual Pharmacovigilance & Risk Management Strategies Conference in Amsterdam, Netherlands.  This event struck me as unique because the conversations were not theoretical; we had a room full of professionals who were able to speak from true, tested experience.  We enjoyed debates throughout the day, exploring both sides of many issues with hands-on presenters who are actually working day-in and day-out within their areas of expertise. 
Reflecting on a great day of professional collaboration, I’ve noted several key takeaways:

  1. The Pharmacovigilance Risk Assessment Committee (PRAC), which has become so influential in our industry, was the topic of two great presentations: one from a PRAC member and one from an industry representative.  It’s interesting to note that both speakers welcomed the added transparency that PRAC has achieved with healthcare professionals and patients. However, both were also quick to recognize that there are timeline challenges in communicating rapidly with Market Authorisation Holders, particularly in relation to the PRAC’s assessment of new signals.
  2. The new black triangle symbol for medicines subject to additional monitoring sparked a lively debate and an audience vote confirmed an audience not in favour of this initiative. This was primarily due to a consensus that currently neither healthcare professionals nor patients have a good understanding of adverse event (AE) reporting, and there is the potential that this will add confusion.  There was a call for programmes of education of healthcare professionals surrounding the reporting of AEs.
  3. In our conversation around Outsourcing in Pharmacovigilance, the importance of forging trustworthy partnerships between client and provider was stressed.  Performing thorough risk/benefit analyses before selecting an outsourcing partner was recommended, and the audience was instructed on how to better anticipate, and mitigate, the risks that may come with outsourcing.
  4. Development Safety Update Reports (DSUR) and Risk Management Plans (RMPs) of mature products were explored.  The consensus was that a significant amount of work is happening in the industry, but, particularly in relation to DSURs, feedback from regulators has been lacking.  It was felt that for mature products, the work involved in producing a RMP was large and disproportional to the product’s risk.  The approach to preparing a RMP for a mature product is very different to that for a product which is subject to first Market Authorisation application.
  5. We enjoyed a comprehensive review of pharmacovigilance inspections, including a review of new trends in inspections of the RMP, signal detection, post-authorisation safety studies (PASS) and internal audit. It was apparent that PASS and RMPs are now very much the subject of inspections.
  6. The session on Drug Safety in Vaccines really highlighted the difference in pharmaceutical vaccine pharmacovigilance and the importance of working closely with the manufacturing department because of the high-occurrence of pharmacovigilance issues related to manufacturing. 

I look forward to convening with this group in the future and exploring these issues further as our industry continues to evolve.