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

Dive right into the heart of good vigilance practices with our intensive, 1-hour live session focused on the GVP Module VII. This session is an interactive exploration designed to help you understand the ins and outs of periodic safety update reprots (PSUR). Whether you're in pharmacovigilance, regulatory affairs, or medical writing, mastering the intricacies of this module is crucial for ensuring medicine safety and regulatory compliance. We'll walk you through the key concepts, from the rationale behind PSUR to the guidelines on writing such reports, ensuring you have a solid grasp on the subject.

Now, let's talk about practicality. Having a command over GVP Module VII isn't just ticking a box; it's about ensuring patient safety and making informed decisions in the real world. During this session, we'll bridge the gap between theory and practice by discussing real-world scenarios and examining case studies. By the end of this high-energy hour, you'll not only be adept at navigating the complexities of GVP Module VII but also appreciate its significance in the broader context of pharmaceutical vigilance and patient care. Get ready to boost your expertise and positively impact your work in the pharmaceutical sphere!

With over two decades of dedicated service in the realms of clinical trials and post-marketing surveillance for medicinal products, my professional journey has spanned various roles from Clinical Research Associate to Trial Site Manager, and Drug Safety Manager. Now, as a EU&UK-Qualified Person for Pharmacovigilance, I bring a wealth of knowledge in overseeing the entire product lifecycle. My expertise extends to implementing robust pharmacovigilance systems, adapting with agility to diverse patient populations, and ensuring compliance across the domains of Quality Assurance, Regulatory Affairs, and beyond. This intricate tapestry of experience not only fuels my passion for the field but also enriches my teaching, allowing me to infuse each training session with practical insights and real-world applications.

As the founder and owner of ARC-Traicoa, a German firm that provides comprehensive pharmacovigilance support, I draw on my in-depth understanding of European pharmaceutical law and various databases to impart foundational knowledge as well as the latest trends in GVP. My sessions are a culmination of hands-on experiences tailored to illuminate the nuances of Audits & Inspections, Risk Management, and Clinical Trials — all designed to empower professionals aspiring to master the subtleties of global pharmacovigilance principles.