Pharmacovigilance: From Principles to Practice
Strengthening knowledge of medicine safety
As part of the VISION project, Darnytsia organized a six-hour online workshop entitled “Pharmacovigilance: From Principles to Practice,” dedicated to the fundamental principles and practical applications of pharmacovigilance.
The session was delivered by Viacheslav Turok, Qualified Person responsible for Pharmacovigilance, who guided participants through the key processes involved in monitoring medicine safety and protecting patients throughout the use of medicinal products.
From fundamental concepts to practical applications
The workshop began with an overview of pharmacovigilance, covering its history, core definitions, and scope. It then explored practical approaches to identifying, assessing, and managing the safety risks associated with medicines.
Key topics included:
Adverse drug reactions: Understanding different types of adverse reactions and the principles used to assess causality.
Signal detection and validation: Exploring how potential safety concerns are identified, evaluated, and validated using available evidence.
Risk management plans: Understanding how safety risks are assessed and how appropriate measures are designed to address them.
Risk-minimisation measures: Examining strategies intended to reduce risks and support the safe use of medicinal products.
These topics highlighted the role of pharmacovigilance in detecting emerging safety concerns, evaluating evidence, and supporting decisions that protect patients.
Connecting regulatory knowledge with patient safety
Pharmacovigilance is an essential component of the medicinal product lifecycle. By systematically collecting, evaluating, and monitoring safety information, pharmacovigilance activities help identify potential risks and inform measures to maintain a favourable benefit–risk balance.
The workshop provided participants with a structured overview of these processes, illustrating how pharmacovigilance principles translate into practical activities within the pharmaceutical sector.