The two-day World Drug Safety Conference held in Berlin (12-13 September) covered what’s new in drug safety, the recent EMA revisions and guidance documents plus pharmacovigilance (PV) processes outside Europe. We attended and want to ask if you think there is an opportunity to do more in this space.

PV challenges today

  • Increased volume of documentation / reporting which has a direct impact on cost of PV
  • Restriction of operational budgets for PV departments despite increased complexity of compliance rules
  • Lack of regulatory harmonisation
  • Social media explosion, big data/real world evidence, mobile apps and digital medicine … a huge untapped source of potential health information but raises technical, regulatory, and ethical challenges

Pharma PV reps unanimously agreed that despite patient safety being their core aim, there are currently few concrete examples of how to engage patients in PV projects. How do you see the role of the patient engagement movement in this field?

Send us your views as a reply to this email or by clicking here.