Pharmacovigilance & Introduction to Pharmacovigilance Risk Assessment Committee (PRAC)

The presentation provides a comprehensive overview of the EU pharmacovigilance system and the role of PRAC in ensuring medicine safety. It begins with an introduction to EMA and its network of scientific committees, highlighting PRAC as the central body for post-authorisation safety monitoring. Pharmacovigilance is defined as the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. The presentation emphasizes the importance of continuous safety monitoring throughout a medicine’s lifecycle, from clinical trials to real-world use, and outlines the responsibilities of marketing authorization holders in reporting and managing risks. PRAC’s core functions include signal detection, risk management planning, evaluation of periodic safety update reports (PSURs), and post-authorisation safety studies. The presentation details the structure and tools of PRAC, including its composition, decision-making processes, and mechanisms for taking regulatory action when safety concerns arise. It also explains the structure and purpose of Risk Management Plans (RMPs), including routine and additional risk minimisation measures. Case studies on Qdenga (dengue vaccine) and Apretude (HIV prevention) illustrate how PRAC evaluates safety data and updates product information accordingly. The presentation concludes with insights into signal management, the role of EudraVigilance (the EU’s pharmacovigilance database), and the importance of collaboration among stakeholders—regulators, healthcare professionals, patients, and industry—to protect public health. It underscores that effective pharmacovigilance requires legislation, scientific rigor, and adequate resources.