Pharmacovigilance and Medical Information Outsourcing: Benefits for Biotech
Pharmacovigilance (PV) and medical information (MI) are complementary components of an effective compliance framework. While they serve distinct operational roles, strong coordination between them supports consistent safety management across the product...
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...
