About
Veterinary Pharmacovigilance System: From Compliance to Safety Excellence
An effective Veterinary pharmacovigilance (PV) System is essential to ensure animal welfare, safeguard public health, and maintain trust in veterinary medicines.
A robust system supports early detection of safety issues and enables informed regulatory decision-making, in line with key frameworks such as EU Regulation 2019/6, EU Implementing Regulation 2021/1281, the EMA's Veterinary Good Pharmacovigilance Practices (VGVP), and FDA-CVM guidance documents.
This comprehensive training provides participants with practical knowledge of veterinary PV systems, focusing on the operational procedures and regulatory requirements essential for effective drug safety monitoring.
Building on foundational pharmacovigilance concepts, this module explores the systematic approach to collecting, processing, and managing adverse event data in veterinary medicine.
Participants will gain hands-on understanding of reporting obligations, case management workflows, and compliance requirements mandated by regulatory authorities. The training emphasizes real-world application, equipping professionals with the tools and knowledge needed to implement and maintain robust veterinary PV systems within their organizations.
Programme
Regulatory Framework and Legal Requirements
- Overview of international veterinary PV regulations (EMA, FDA-CVM)
- Legal obligations for Marketing Authorization Holders (MAHs)
- Key VGVP requirements and principles
- PSMF documentation standards and regulatory expectations
Adverse Event Reporting and Case Management
- ICSR (Individual Case Safety Report) requirements and standards
- Adverse event detection and collection methods
- Case intake and initial assessment procedures
- Documentation standards and data quality requirements
- Case follow-up procedures and information gathering
- Expedited reporting requirements for serious adverse events
Risk Assessment and Management Strategies
- Conducting benefit-risk evaluations
- Risk Management Plans (RMPs) in veterinary medicine
- Risk minimization measures and communication strategies
- Monitoring effectiveness of safety interventions
Periodic Reporting and Documentation
- Summary reports for regulatory authorities
- Product safety profiles and maintenance
- Record keeping and archiving requirements
- Quality management and standard operating procedures (SOPs)
Q&A and Wrap-up
- Pharmaceutical professionals already working in Veterinary Pharmacovigilance
- Veterinary pharmaceutical professionals planning to undertake QPPV and/or Deputy QPPV roles
- Quality assurance and regulatory affairs professional
Participant experience
Basic understanding of veterinary pharmacovigilance is needed.
Interactive training including practical session, discussion and Q&A.
Lecturers
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
27 May 2026 from 02:00 pm to 06:00 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 06/05/2026)
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.
Register
Barbara Rossi
Training & Quality Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training