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

Dive right into the heart of pharmacovigilance with our focused live session that's all about navigating the nitty-gritty of Good Pharmacovigilance Practices (GVP) Module VIII – Post-Authorization Safety Studies (PASS). We're breaking it down into digestible chunks, showing you how to implement and manage PASS effectively. Ever wonder how medicinal products continue to be safe after they hit the market? Well, we're going to explore the ins and outs of planning, conducting, and reporting studies that keep tabs on those products, ensuring they're doing more good than harm.

Understanding this module isn't just about ticking a compliance box; it's about elevating your role in the healthcare industry. By the end of this power hour, you'll not only grasp the importance of post-authorization safety studies but also how they fit into the bigger picture of patient health and product lifecycle management. This course will arm you with the know-how to contribute to safer pharmaceuticals on the shelves, potentially impacting healthcare protocols and patient outcomes on a global scale. From industry professionals to budding pharmacovigilance enthusiasts, let's turn the page together on enhancing therapeutic safety.

With over two decades of deep immersion in the field of clinical trials and pharmacovigilance, my career has spanned roles as a Clinical Research Associate (CRA), Trial Site Manager, and Drug Safety Manager, overseeing the complexities of global clinical trials and the post-marketing landscape for a diverse array of medicinal products. My journey has honed my expertise in safeguarding patient safety across various indications and age groups, culminating in my current role as an EU & UK-Qualified Person for Pharmacovigilance. In this capacity, I am entrusted with the comprehensive management of medicinal product lifecycles, expertly navigating the intricacies of supplemental products, medical devices, and regional pharmacovigilance for the DACH area. My eclectic experience extends to supporting audits, inspections, quality assurance efforts, regulatory affairs, as well as manufacturing and marketing processes.

As the founder of ARC-Traicoa, I cater to an overarching commitment to pharmacovigilance excellence, bringing the nuances and critical importance of this field to life for those I teach. My passion for imparting knowledge is fueled by a hands-on approach gathered from navigating regulatory frameworks and databases, coupled with extensive practice in risk management and GVP principles. It is this rich tapestry of real-world experience and dedication to continuous learning that I bring to the classroom, aiming to empower students with the practical insights and expertise required to excel in the dynamic realm of pharmacovigilance.