Navigating Pharmacovigilance Requirements in LATAM

In the first episode of our new video series, Biomapas Insights, Albert Bekfi, Head of Global PV Operations at Biomapas, is in conversation with Raul Flores Medina, Local Safety Officer for LATAM, about the evolving Pharmacovigilance landscape across the LATAM region.

In the discussion, they cover:

• When and where the nomination of Local Safety Officers (LSOs) is mandatory
• Core responsibilities and qualifications required for LSOs
• Differences in regulatory obligations across LATAM countries
• Trends in ICSR reporting and patient support programmes
• How PV inspections and enforcement are currently handled

Whether you are navigating new market entries or refining local operations, this episode offers valuable information about regulatory expectations and compliance best practices across LATAM.