Introduction The advent of the digital revolution has changed many sectors, and regulatory affairs is no different. As technology evolves, so must the frameworks and approaches that regulate it. In…

Introduction Pharmacovigilance services in Kenya play a key role in addressing drug safety. The Pharmacy and Poisons through the Pharmacovigilance Centre, manages these activities in collaboration with healthcare experts, the public and other stakeholders, to promote the effectiveness of pharmacovigilance. Continued efforts are needed to address critical issues such as underreporting and resource limitations. Accountability through the appointment of a qualified Person for Pharmacovigilance  Outsourcing Pharmacovigilance services is an important business model. It can increase efficiency by more than 50 % and save at…

Pharmacovigilance Guidelines Update in Kenya – 2024 Introduction The pharmacovigilance regulations and landscape in Kenya are rapidly changing. In 2023, the Kenya Pharmacy and Poisons Board updated the Kenya guidelines…

Good Pharmacovigilance Practices as discussed in our previous articles forms the fundamentals that ensures drug use is safe. The implementation of  good pharmacovigilance practices also confers other benefits to the…

Introduction The pharmaceutical sector operates within one of the most detailed regulated industries there is, and a lengthy process from submission to approval for drugs. Regulatory affairs is a crucial…

Why Good Pharmacovigilance Practice Is More Vital The Pharmacovigilance practice has been evolving over time. The need for pharmacovigilance practices can be traced back to the very first individual case…

Introduction Pharmacovigilance (PV) outsourcing is the mainstay solution for small to medium size businesses. Pharmacovigilance outsourcing (PVO) transfers the execution of drug safety functions and processes to a third-party service…

Introduction Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is…

ChAdOx1 nCOV-19 Vaccine Trial 1. What is the ChAdOx1 Vaccine Trial? This trial aims to assess whether the ChAdOx1 vaccine is safe, effective and provides immunity against COVID-19 in adults aged…

Reporting suspected adverse events with medical devices The safety and performance of medical devices have a great and direct impact on patient safety. Errors, failures and defects in medical devices…