Walk-through GVP Modules (GVP XV & XVI) - 1 h Live Session

Dive into the world of pharmacovigilance with this engaging 1-hour live session, tailored to demystify the specifics of Good Pharmacovigilance Practices, focusing on the all-important Modules XV and XVI. These modules are the cornerstone of risk management and safety communication, crucial for anyone in the pharmaceutical or healthcare industries. You'll gain a comprehensive overview of the regulatory framework, understand the requirements for risk management plans, and learn how to effectively communicate safety information.

We'll explore practical strategies and best practices to implement these guidelines in your daily operations, reducing the potential for patient harm and ensuring regulatory compliance. This session isn't just about theory; it's about giving you the tools and know-how to make a real difference in the quality of drug safety. Whether you're a healthcare professional, a member of the pharmaceutical industry, or simply keen to learn more about pharmacovigilance, this course will bridge the gap between knowledge and action, giving you a clear advantage in your field.

With over two decades of in-depth involvement in clinical trials and post-marking surveillance, my professional journey has spanned roles as a Clinical Research Associate, Trial Site Manager, and Drug Safety Manager across a spectrum of global clinical studies and patient demographics. I currently uphold the responsibilities of an EU & UK-Qualified Person for Pharmacovigilance, scrutinizing the full lifecycle management of medicinal products, supplementals, and medical devices, while also serving as the Pharmacovigilance Lead for the DACH region. My proficiency extends through aiding in audits and inspections, ensuring quality assurance, and enhancing regulatory affairs, with a potent combination of expertise in several pharmacovigilance databases and a thorough understanding of European pharmaceutical legislation.

At the core of my professional ethos is a commitment to share knowledge and insights gained from my rich experience. As the founder of ARC-Traicoa, I dedicate myself to fostering a culture of safety and vigilance in the industry by providing tailored support in pharmacovigilance. This dedication is mirrored in my passion for educating professionals through my training sessions at the FORUM Institut, where I bring theoretical principles to life with practical insights in Audits & Inspections, Risk Management, Good Pharmacovigilance Practices (GVP), and Clinical Trials. My involvement in teaching is fueled by the desire to empower and inspire new experts, equipping them with the knowledge and tools to excel in our ever-evolving field.