Reports & Studies

1. Introduction The Qualified Person for Pharmacovigilance (QPPV) Learning Summit was convened by the KAPI – Industry Alliance of Health Products and Technologies Pharmacovigilance and Medical Affairs Committee Working Group to strengthen pharmacovigilance capacity in Kenya. The summit aimed to foster best practice sharing, regulatory understanding, and professional networking among Pharmacovigilance professionals. PPB has been […]

Executive Summary Serialization and track and trace are critical components in the pharmaceutical industry, designed to enhance the safety and integrity of the supply chain. Serialization refers to the process of assigning a unique identifier, typically a serial number, to each saleable unit of a product. This identifier allows for the precise tracking of individual

Executive Summary Introduction and Purpose The Regulatory Reliance Workshop held on March 20, 2025, in Nairobi, Kenya, brought together experts from the Pharmaceuticals and Medical Devices sectors to discuss Regulatory Reliance, its implementation, benefits, and challenges in Kenya. Among the participants included members of KAPI, MEDAK, representatives from the Pharmaceutical Society of Kenya, Federation of