One day national workshop and hands on training on Pharmacovigilance ADR form filling and Vigiflow Software

Workshop Overview

This one-day national workshop is designed to provide participants with a foundational understanding of pharmacovigilance, the critical process of adverse drug reaction (ADR) reporting, and hands-on proficiency with a leading industry software, Vigiflow. The training is tailored for aspiring and current pharmacovigilance professionals, pharmacy students, clinicians, and researchers who are keen to develop practical skills in drug safety reporting and data management. The workshop provides a robust blend of theoretical principles and practical application, addressing the urgent need for trained professionals who can navigate the complexities of modern drug safety monitoring. Participants will gain a deep understanding of the regulatory frameworks governing adverse drug reaction (ADR) reporting, both nationally and internationally.

. The program delves into key concepts such as causality assessment, signal detection, and risk management, which are vital for identifying and mitigating potential drug-related risks. The sessions will cover the entire lifecycle of an ADR case, from initial detection and documentation to its final submission to regulatory authorities. A significant highlight of this training is the dedicated hands-on session focusing on Vigiflow software. Vigiflow is a web-based, individual case safety report (ICSR) management system developed by the Uppsala Monitoring Centre (UMC).

It is widely used by national pharmacovigilance centres to collect, process, and analyze adverse event data. Through practical, simulated exercises, participants will learn how to efficiently navigate the software, including data entry for various case types (standard and parent-child cases), using integrated terminologies like MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug Dictionaries, and generating required reports. Proficiency in such industry-standard tools is a highly sought-after skill that significantly enhances career prospects in the pharmacovigilance sector. By the end of this workshop, attendees will possess the competencies to: understand the pivotal role of pharmacovigilance in public health, accurately identify and report ADRs, and confidently utilize a key pharmacovigilance software.

This training is ideal for pharmacy students, clinical research associates, medical professionals, and anyone interested in a career in drug safety. Ultimately, this program is more than just a training session; it is an investment in professional development that contributes directly to a safer healthcare ecosystem for all.