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The Course
Hey there, are you ready to dive deep into the world of Good Pharmacovigilance Practices? Our interactive session is geared to help you master GVP Module VI, which focuses on the collection, management, and reporting of adverse events linked to medicinal products. You'll get a clear picture of the regulatory framework and responsibilities that ensure patient safety and public health are not compromised. From recognizing what constitutes an adverse event to understanding the intricacies of post-marketing surveillance, this intense one-hour live training is packed with essential knowledge for professionals in the pharmaceutical and healthcare industries.
Now, why should you care about this? Because whether you're a pharmacovigilance expert, drug safety officer, or part of a clinical research team, knowing the ins and outs of GVP Module VI is crucial. It's the cornerstone for making informed decisions and implementing effective surveillance strategies. By the end of our session, you'll have practical skills that can immediately be applied to your work, enhancing your ability to safeguard patient health and ensuring compliance with international standards. So come on, let's get to grips with the nitty-gritty of pharmacovigilance together and take your expertise to the next level!
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 the GVP Module just for awareness, 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 a deep-rooted passion for advancing patient safety and over two decades dedicated to the pharmaceutical sector, my career has been a diverse journey through various pillars of clinical trials and pharmacovigilance. My experience stretches from hands-on roles as a Clinical Research Associate and Trial Site Manager to strategic positions like Drug Safety Manager and EU&UK-Qualified Person for Pharmacovigilance. My comprehensive understanding of drug development and safety surveillance is built on a foundation of managing global clinical trials across different indications and patient demographics, ensuring compliant product lifecycle oversight, and navigating through complex pharmacovigilance obligations, especially within the DACH region. This extensive practical know-how is what I bring into each teaching session, striving to connect theory with real-world application, and igniting a passion for GVP in professionals eager to make their mark in the field.
As the founder of ARC-Traicoa, I channel my expertise into supporting organizations in all facets of pharmacovigilance, from audit readiness to regulatory adherence. This venture not only showcases my dedication to the industry but also enriches my teaching, as it provides a current and hands-on perspective to my coursework. I pride myself on delivering training that empowers participants with knowledge that's both comprehensive and immediately applicable, helping to shape informed and skilled experts in pharmacovigilance who are equipped to uphold the highest standards of medicinal product safety.
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In-depth
Exploring Pharmacovigilance Core Elements
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Comprehensive
A Thorough Guide to Risk Management Plans
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Insightful
Key Strategies for Signal Management