Comprehensive Guide to Medical Information and Pharmacovigilance Integration
Is medical information (MI) and pharmacovigilance (PV) integration still optional? The short answer is no. Regulators expect every enquiry, report, and safety update to connect seamlessly. When these functions work in isolation, gaps appear, and those gaps create...
Biomapas Insights: From Hope to Global Impact – How Elpida Accelerated Gene Therapy for Rare Diseases
In this Biomapas Insights episode, Martijn van de Leur, Chief Commercial Officer, speaks with Terry Pirovolakis, CEO of Elpida Therapeutics, the organisation that grew out of the CureSPG50 advocacy movement. Together, they explore how a parent-led mission to help...
Choosing the Right QPPV Partner for EU and Global Compliance
Pharmacovigilance outsourcing has become crucial for biotech companies to remain compliant and safeguard patients. When you bring a drug to market in Europe or globally, your Qualified Person for Pharmacovigilance (QPPV) serves as your first line of defense. The right...
How to achieve Multi-Region Pharmacovigilance Compliance: Critical Lessons from CIS and MENA
Navigating local nuances can significantly impact a company’s ability to retain market access. For biotech and pharmaceutical companies, these markets are essential expansion zones with growing demand. But the path to compliance isn’t simply a matter of translating...
