7th Good Vigilance Practice (GVP) Course – Semmelweis University

Master EU Pharmacovigilance with Confidence

The 7th Good Vigilance Practice (GVP) Course organized by Semmelweis University delivers a comprehensive, practice-oriented training on European Union pharmacovigilance requirements. The program is fully aligned with current EU GVP legislation and focuses on both regulatory compliance and real-world implementation.

Why This Course Matters

Pharmacovigilance is a rapidly evolving regulatory field. This course provides a structured, end-to-end overview of all EU GVP Modules, complemented by insights into emerging trends, novel regulatory challenges, and high-impact developments shaping pharmacovigilance today.

Participants gain not only theoretical knowledge, but also practical guidance directly applicable to daily pharmacovigilance activities.

Comprehensive Curriculum Covering All GVP Modules

The curriculum includes a detailed review of all EU-level pharmacovigilance legislation and GVP Modules, delivered in a logical and easy-to-follow structure.

Core Topics

• Full overview of EU GVP Modules (I–XVI)
• Roles and responsibilities within pharmacovigilance systems
• Signal management, risk management, and benefit–risk evaluation
• Pharmacovigilance system management and oversight

Extended & Emerging Topics

• Medical device vigilance and interface with pharmacovigilance
• Pharmacovigilance inspections and audit readiness
• Latest academic research and scientific developments
• Emerging regulatory expectations and future trends

Expert-Led Training

All modules are delivered by a distinguished faculty of regulatory authority representatives and senior industry experts. This ensures that participants benefit from:

• First-hand regulatory insight
• Practical industry perspectives
• Real-world case examples and best practices

Who Should Attend?

This course is primarily designed for pharmacovigilance professionals, but it also offers significant value for experts working in related disciplines:

• Pharmacovigilance specialists and safety scientists
• Regulatory affairs professionals
• Medical affairs professionals
• Quality assurance and compliance experts
• Healthcare professionals involved in patient safety

The content is suitable for both experienced professionals seeking an update and those aiming to strengthen their regulatory foundation.

Industry-Recognized Certification

Upon successful completion of the course, participants receive a certificate recognized by the pharmaceutical industry, confirming their knowledge of EU Good Vigilance Practice (GVP).

The certificate is also accepted as external pharmacovigilance training, supporting regulatory compliance, audits, and continuous professional development.

What You Will Gain

By completing the course, participants will:

• Gain a thorough understanding of EU pharmacovigilance requirements
• Improve confidence in applying GVP principles in practice
• Stay up to date with current and emerging regulatory expectations
• Strengthen their professional profile with an industry-recognized certificate

Take the Next Step

Advance your pharmacovigilance expertise with one of Europe’s leading academic programs.

• Register now to secure your place
• Download the detailed program to explore the full curriculum
• Contact us for group registrations or institutional participation

Join the 7th GVP Course and gain a complete, practical understanding of EU pharmacovigilance.

Frequently Asked Questions

Is this course aligned with current EU GVP legislation?
Yes. The curriculum is fully aligned with the latest EU GVP requirements and regulatory guidance.

Is the certificate recognized by the pharmaceutical industry?
Yes. The certificate is recognized by the pharmaceutical industry and accepted as external pharmacovigilance training.

Is this course suitable for non-pharmacovigilance professionals?
Yes. Professionals from regulatory affairs, medical affairs, quality assurance, and healthcare will also benefit from the in-depth content.

Does the course include practical examples?
Yes. The program includes real-world case studies and practical insights from both regulators and industry experts.

Essential information:

• Organizer: Semmelweis University, Department of Pharmacology and Pharmacotherapy
• Accreditaion ID: SE-SZTOK/2026.II/00106
• Audience: pharmacovigilance professionals (entry level for general training, mid-senior level for field specific information), healthcare professionals
• Date: 17–18 September 2026
• Language: English
• Fee: 99 500 HUF
• Venue: Online course via Zoom
• Outcome: GVP Training certificate after successful written exam

List of lectures