Post-Market Surveillance: The Lifesaver No One Talks About.
We often focus on clinical trials when thinking about the safety and effectiveness of medicines and devices. But what happens after a product is approved and widely used? That’s where…
Africa’s ML3 and QPPV: Elevating Pharmacovigilance for Safer Medicines
A Qualified Person for Pharmacovigilance (QPPV) plays a crucial role in ensuring patient safety and regulatory compliance in the pharmaceutical industry. As more countries enhance their pharmacovigilance (PV) systems, the…
Signal Detection and Management in Pharmacovigilance
In the ever-evolving field of pharmacovigilance, the ability to detect and manage signals effectively plays a pivotal role in safeguarding public health. Signal detection and management in pharmacovigilance involves identifying…
Local Technical Representative (LTR): Simplifying Market Entry in Africa
In the dynamic and highly regulated pharmaceutical industry, Local Technical Representatives (LTRs) play a pivotal role in simplifying market entry in Africa. They bridge the gap between regulatory authorities and…
The Role and Importance of the Qualified Person for Pharmacovigilance (QPPV)
Patient safety drives the pharmaceutical industry, and the Qualified Person for Pharmacovigilance (QPPV) plays a central role in ensuring it remains a top concern by overseeing pharmacovigilance systems, monitoring product…
Jeyflex Journey to ISO 9001:2015 Certification: Commitment to Quality Excellence
At Jeyflex Consultants, we pride ourselves in providing world-class compliance design services to pharmaceutical companies. That’s why we were determined to achieve ISO 9001:2015 certification; the globally recognized standard for…
Regulatory Affairs in Digital Age
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…
Pharmacovigilance Services in Kenya
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…
Regulatory Affairs: New Drug Registration Process
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…