Introduzione
Veterinary Pharmacovigilance Quality Management System (QMS)
In an increasingly regulated and interconnected animal health environment, ensuring the safety of veterinary medicinal products is a fundamental responsibility that directly impacts animal welfare, public health, and the integrity of the food chain.
Effective pharmacovigilance across the product lifecycle depends on a robust and well-structured Quality Management System (QMS) capable of supporting reliable safety monitoring and sound benefit-risk management.
This intensive 4-hour training provides veterinary pharmacovigilance professionals with the essential knowledge and practical tools to establish, maintain, and continuously improve QMS frameworks in line with EU legislation, GVP guidance, and VICH standards. Through practical examples and real-world scenarios, participants will learn how quality principles are embedded in daily pharmacovigilance activities - from case processing and signal management to risk communication and PSMF maintenance — and how compliance is assessed during regulatory inspections.
Designed for pharmacovigilance, quality assurance, regulatory, medical, and cross-functional professionals, the course equips participants to build compliant, efficient, and inspection-ready systems that safeguard both animal and public health.
Programme
Regulatory Framework for Veterinary PV Quality Management – (50 minutes)
- EU Regulation 2019/6 and 2021/1281: quality system obligations
- GVP Module on PV systems and quality management systems
- VICH GL pharmacovigilance standards and global alignment
- Translating regulatory requirements into operational practice
QMS Components, Governance & Documentation – (70 minutes)
- Essential QMS components: policy, objectives, and organizational structure
- QPPV role, mandate, and accountability within the PV system
- Governance structures and cross-functional responsibilities (PV, QA, Regulatory)
- Documentation hierarchy: SOPs, work instructions, templates, and record management
- Pharmacovigilance System Master File (PSMF): content, maintenance, and availability
Break (10 minutes)
Quality Oversight, Audits & Performance Monitoring – (70 minutes)
- Quality control checks across key PV processes (case processing, signal detection, PSURs)
- Key performance indicators (KPIs) and quality metrics for compliance monitoring
- Internal audit planning, execution, and reporting
- Vendor and distributor oversight
- CAPA management: corrective and preventive actions
- Management review, dashboards, and continuous improvement
Practical Application & Wrap-up – (50 minutes)
- Practical exercise: mapping regulatory requirements to QMS components
- Key takeaways, Q&A, and knowledge check
- Veterinary pharmacovigilance professionals
- Quality assurance specialists (animal health)
- Regulatory affairs personnel
- Medical professionals & cross-functional stakeholders
- PV system owners and Qualified Persons (QPPV)
Highly interactive training with practicas sessions
Docente/i
Camilo Giraldo
Camilo Giraldo is a veterinarian with over 30 years of experience in the animal health pharmaceutical industry and is internationally recognized for his leadership in veterinary pharmacovigilance. Based in Switzerland for the past two decades, he has played a key role in shaping global safety systems and advancing scientific standards in signal management.
As Director of Global Pharmacovigilance – Signal Management at Elanco, Camilo led the implementation of a global program that improved the speed and accuracy of safety signal analysis by 40%, ensuring regulatory compliance across multiple regions. His work strengthened global product safety oversight and supported proactive risk mitigation strategies that protect both animal and public health.
Camilo has published and presented internationally on advanced methodologies in pharmacovigilance, including the use of machine learning for signal detection. A frequent speaker and trainer at major regulatory and industry forums, he previously held senior roles at Novartis Animal Health and taught in Veterinary Pharmacology at the University of La Salle, Colombia.
Online Training – 1 module
10 June 2026 from 2:00 pm to 6:00 pm CEST
Few days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 490,00* (until 20/05/2026)
Ordinary: € 620,00*
Freelance – Individual – Academy – Public Administration: € 390,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Ilaria Butta
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training
