Vicore Health News
Insights, updates, and developments across regulatory and technology-driven healthcare in Africa.
What “Human-in-the-Lead” Really Means in Pharmacovigilance and Regulatory Affairs
By Émile Malan, Managing Director, Vicore Health Moving Beyond “Human-in-the-Loop” “Human-in-the-loop” has become one of the most common phrases in conversations about AI in pharma. Regulators use it. Vendors use it. Compliance teams use it. But in pharmacovigilance and regulatory affairs, it is the wrong way to think about AI..
The Literature Surveillance Gap Most South African MAHs Don’t Know They Have
A patient in Limpopo receives a generic antiretroviral from a local clinic. Months later, she develops an adverse reaction that has already been documented in a case report published in a regional African medical journal. The journal is not indexed by PubMed or Embase. Her prescriber has not seen it..
What Regulatory Reliance Means for Africa’s Health Future
Across Africa, access to safe, effective, and quality-assured medicines is shaped as much by regulatory systems as it is by scientific innovation. While many countries have made significant progress in strengthening their National Regulatory Authorities (NRAs), uneven capacity, fragmented requirements, and duplicated assessments continue to slow patient access to essential.