Walk-through GVP Modules (GVP IX & X) - 1 h Live Session

Ever felt lost navigating the intricacies of Good Pharmacovigilance Practices (GVP)? Dive into our lively one-hour session where we unravel the complexities of GVP Modules IX and X—two critical pieces in the pharmacovigilance puzzle. We'll guide you through the key aspects of GVP IX, which zooms in on signal management, ensuring you're up to speed on detecting and managing risks associated with medicinal products. Following that, we'll tackle GVP X, emphasizing the importance of additional monitoring and laying the groundwork for how it strengthens the safety profile of drugs that raise particular concerns.

This interactive session is jam-packed with relatable examples and actionable insights, making it super practical for anyone embarking on a career in pharmacovigilance or looking to sharpen their existing skills. By the end, not only will you be comfortable with the requirements and processes defined in these modules, but you'll also be ready to apply them confidently in real-world contexts. It's about giving you the tools to enhance patient safety and contribute meaningfully to public health, all without getting tripped up by the regulatory hurdles. So, whether you're a professional in the field or just curious about pharmacovigilance, you're in for an engaging and enlightening experience that will pay dividends in your professional journey.

With over two decades of expertise in clinical trials and pharmacovigilance, my career has spanned an array of roles including Clinical Research Associate, Trial Site Manager, and Drug Safety Manager across international clinical trials and product lifecycles. I am an EU&UK-Qualified Person for Pharmacovigilance, entrusting me with the oversight of medicinal products from concept to consumption, including supplementals and medical devices, particularly in the DACH region. My competencies extend to supporting audits, inspections, Quality Assurance, Regulatory Affairs, and integrating these disciplines within the Manufacturing and Marketing spheres. My grasp of pharmaceutical databases and European pharmaceutical law is both extensive and practical, which I convey with enthusiasm to those I train in areas such as GVP, Risk Management, and Clinical Trials for FORUM Institut.

As the founder and owner of ARC-Traicoa, based in Germany, my commitment to the field transcends professional service—transitioning into mentorship and knowledge sharing. Being deeply passionate about cultivating expertise in pharmacovigilance, I infuse my teaching with real-world insights and applications. My aim is to inspire and empower professionals to uphold and innovate within the arena of Good Pharmacovigilance Practices (GVP), ensuring safety and efficacy remains paramount in the pharmaceutical landscape. Through this course, I anticipate sharing not just knowledge but the excitement and significance of the pivotal roles we play in GVP Modules IX & X.