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The Course
Hey there! If you're eager to dive into the nitty-gritty of Good Pharmacovigilance Practices (GVP), you've found just the thing. This whistle-stop, 60-minute live session is jam-packed with insights on the essential modules that set the standards for monitoring the safety of medicines. We'll guide you through the critical components of GVP, from adverse event reporting to risk management plans. You'll gain a solid grasp of the regulatory frameworks that safeguard patient health, and understand how to implement these GVP modules within your organization.
Now, why should you care? Well, this knowledge isn't just for your personal toolkit; it's about making a tangible impact in the medical world. Throughout our session, we'll highlight real-world applications that showcase the importance of robust pharmacovigilance systems. Whether you're a newcomer to the pharmaceutical industry or looking to update your expertise, understanding GVP is crucial for ensuring the safe use of medicines on the market. By the end of this power hour, you'll have a newfound confidence in navigating the complexities of drug safety—a skill that'll make you an invaluable asset to any healthcare team.
What you will learn
Main focus is the 1 hour live session in which I will share my experience.
We will discuss the EMA guidelines and I am open to your questions.
If you like to can read through the outline just to prepare, but it is not required.
Curriculum
Presentation will be available shortly before the day of presentation.
Link to the meeting will be shared to all students.
Recording will be available for 3 months.
Your instructor
With over two decades dedicated to the dynamism of clinical trials and pharmacovigilance, I carry a wealth of practical insights and industry knowledge, having navigated roles as a CRA, Trial Site Manager, and Drug Safety Manager. Now as an EU&UK-Qualified Person for Pharmacovigilance, I vigilantly oversee the lifecycle of medicinal products, ensuring compliance across the DACH region. My experience extends to supporting audits, regulatory affairs, quality assurance, and enriching teams with my proficiency in pharmacovigilance databases and European pharmaceutical legislation.
I channel my passion for patient safety and industry best practices into educating others, as I recognize the power of shared knowledge. In partnership with the FORUM Institute, I have designed and delivered comprehensive training modules on GVP, audits, risk management, and clinical trials. With ARC-Traicoa, the company I founded, I continue to focus on enhancing pharmacovigilance standards and efficacy, enriching the sector with unwavering dedication and an eye toward innovation.
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In-depth
Exploring the Nuances of Good Pharmacovigilance Practice
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Comprehensive
Your Complete Guide to Mastering GVP Modules
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Interactive
Engage & Learn: A Participatory Approach to GVP