The Course

Dive into the essentials of Good Pharmacovigilance Practices (GVP) with our engaging live session, designed to give you a brisk yet comprehensive overview of GVP modules. Whether you're a newcomer to the field of pharmacovigilance or looking to brush up on the latest regulatory frameworks, this session is tailored to streamline your understanding of how these critical guidelines safeguard patient safety and ensure the efficacy of medical products. Throughout this interactive hour, we'll unpack the key components, unpacking everything from adverse event reporting to risk management strategies, all while encouraging real-time questions and discussions to solidify your grasp on the material.

But why stop at mere understanding? The real spice of learning comes from applying this knowledge effectively in the ever-evolving world of pharmaceuticals and healthcare. By participating in this session, you'll not only become familiar with the theoretical aspects of GVP, but you'll also learn how to navigate through the practical challenges professionals face in this regulatory minefield. Get ready to translate what you learn into actionable insights that can propel your career forward and contribute to the critical work of ensuring drug safety and efficacy in everyday healthcare practice.

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.

  Live Session - GVP Module I
Available in days
days after you enroll

Choose a Pricing Option


Choose the suitable timeslot for you. Pay attention, time is shown as Central European Time!

If you cannot join live, the session will be recorded and will be made available to you.

The meeting link will be sent to you after purchase once your enrollment is checked.

Only limited seats!


If you wish to pay via PayPal - Paypal option is only possible when you choose to pay US$ (setting of teachable).

Your instructor

With over two decades immersed in the ever-evolving world of clinical trials and post-marketing, I bring a wealth of frontline knowledge and experience to this live session on GVP Modules. My journey through various pivotal roles, including Clinical Research Associate, Trial Site Manager, and Drug Safety Manager across international clinical trials, has refined my expertise in overseeing product lifecycles and ensuring excellence in pharmacovigilance practices. As an EU&UK-Qualified Person for Pharmacovigilance, I have nurtured a profound understanding of the intricacies within various patient demographics, medicinal products, and medical devices, particularly within the DACH region. My tenacity for upholding standards shines through my commitment to guiding industry professionals in Quality Assurance, Regulatory Affairs, Manufacturing, and Marketing, backed by an in-depth grasp of pharmaceutical databases and European law.

The passion that fuels my day-to-day responsibilities also ignites my enthusiasm for teaching. As the founder of ARC-Traicoa, I have cultivated a platform for sharing industry insights and elevating pharmacovigilance practices. Whether it's dissecting audits & inspections, navigating risk management, or exploring the nuances of GVP and Clinical Trials, my instructional approach is informed by years of fieldwork and a genuine desire to empower others with the knowledge and skills to excel in this critical healthcare sector. Join me as we delve into the complexities of GVP together, fostering a deeper understanding and mastery of pharmacovigilance principles that can be applied practically in your career.

Comprehensive

A Thorough Exploration of Good Vigilance Practices

Interactive

Engage Directly with GVP Experts in a Dynamic Setting

Foundational

Essential Insights for Effective Pharmacovigilance