Walk-through GVP Modules (GVP V) - 1 h Live Session

Dive into the world of Good Pharmacovigilance Practices (GVP) with a laser-focused, 60-minute interactive session designed to give you a comprehensive understanding of the fifth module of GVP, 'Risk Management Systems'. This critical piece of the puzzle is all about ensuring the safety of medicinal products and ultimately protecting patient health. You'll get to grips with the essential concepts of risk management, learn how to evaluate and minimize potential drug risks, and understand the strategies for effective communication within the risk management system. It's practical knowledge that's priceless for professionals in the pharmaceutical and healthcare sectors.

By the end of this power-packed hour, you'll not only have a solid grasp of the key elements of GVP Module V but you'll also see how they apply in real-life scenarios. Whether you're in clinical development, post-market surveillance, or regulatory affairs, mastering risk management is vital. And that's exactly what you'll get—a boost in your ability to implement robust risk management plans that align with global regulatory requirements. So saddle up, because we're about to take a walk through one of the most essential components of drug safety—you'll walk out ready to tackle the challenges head-on and with confidence!

Drawing upon over two decades of in-depth experience in the clinical trial and post-marketing spheres of medicinal products, I bring a wealth of knowledge to the table. As a seasoned professional who has navigated roles as a Clinical Research Associate (CRA), Trial Site Manager, and Drug Safety Manager, I have a nuanced understanding of the intricacies involved in global clinical trials and post-marketing across diverse indications and patient demographics. My current role as an EU & UK-Qualified Person for Pharmacovigilance offers me an overarching perspective on the product lifecycle management of medicinal products, supplementals, and medical devices. My hands-on experience in Quality Assurance, Regulatory Affairs, and the challenges of local pharmacovigilance, particularly for the DACH region, reinforces my competence in guiding you through the complexities of our field.

My commitment to pharmacovigilance extends beyond my professional pursuits as the founder and owner of a specialized German company, ARC-Traicoa, where I dedicate my efforts to support all facets of pharmacovigilance. My enthusiasm for imparting knowledge is reflected in the comprehensive training I provide on vital topics such as Audits & Inspections, Risk Management, GVP, and Clinical Trials. In this course, you'll benefit not only from my extensive expertise but from my genuine passion for teaching and fostering a better understanding of pharmacovigilance practices that safeguard patient safety and contribute to the advancement of healthcare.