Introduzione
Veterinary Signal Management
Signal management is the cornerstone of proactive veterinary pharmacovigilance.
As regulatory expectations evolve - driven by EU Regulation 2019/6, Veterinary Good Pharmacovigilance Practices (VGVP), VICH guidelines, and increasing convergence with international standards - the ability to systematically detect, validate, assess, and communicate safety signals has become a defining competency for pharmacovigilance professionals in animal health.
This intensive training offers a focused, practical immersion into signal management for veterinary medicinal products.
Drawing on real-world experience and regulatory intelligence, the course takes participants through the complete signal lifecycle - from spontaneous report collection and data mining to risk characterization, regulatory communication, and benefit-risk decision-making.
Rather than revisiting the broad foundations of pharmacovigilance, this course builds on prior knowledge to sharpen signal-specific skills. Participants will work through hands-on exercises, apply qualitative and quantitative detection methods, and develop the analytical confidence needed to navigate complex signals and regulatory interactions.
Programme
Signal Management Foundations & Regulatory Context
Signal Management in the Regulatory Landscape
- Why signal management matters: regulatory and safety perspectives
- VGVP requirements for signal management (EMA Modules), VMD perspective
- VICH GL24 / GL35 / GL42 signal-related obligations
- Roles of MAH, QPPV, EMA, NCAs in the signal lifecycle
- Key definitions: signal, validated signal, disproportionality, benefit-risk
Data Sources & the Signal Lifecycle
- Data sources for signal inputs
- The signal management workflow: detection → validation → assessment → action → communication
- EVVet, Union Pharmacovigilance Database, and other key data repositories
- Case triage and prioritization frameworks
Detection Methods, Assessment & Risk Management
Qualitative & Quantitative Signal Detection
- Qualitative approaches: expert judgment and clinical context
- Disproportionality analysis: PRR, ROR, IC — principles and interpretation
- Data mining strategies: strengths, limitations, and practical thresholds
- Real-world exercise: applying detection methods to a database scenario
Signal Prioritization & Validation, Assessment & Risk Communication
- Validating a signal: criteria, documentation, and regulatory expectations
- Benefit-risk assessment methodology in a veterinary context
- Risk minimization measures and their implementation
- Communicating signals to regulatory authorities: content, format, and timing
- Case study: from detection to regulatory submission
– Digital transformation and AI in signal detection
This course is intended for pharmacovigilance professionals seeking to strengthen their expertise in signal management, including QPPVs and Deputy QPPVs with oversight responsibilities.
It is also suitable for regulatory affairs and drug safety professionals involved in benefit–risk evaluation, as well as PV managers and team leads implementing or auditing signal management systems.
In addition, it is relevant for quality assurance professionals with PV oversight duties, veterinary pharmaceutical professionals moving into signal management roles, and experienced PV practitioners wishing to update their skills in line with current GVP requirements.
Participant experience
Participants are expected to have a working knowledge of veterinary pharmacovigilance fundamentals, including familiarity with adverse event reporting (ICSR), basic regulatory frameworks (EU Regulation 2019/6, VICH guidelines), and the role of the QPPV.
Prior exposure to signal detection concepts is beneficial but not strictly required — the course is designed to build and consolidate signal-specific competencies from a solid PV foundation.
Highly interactive training with practical 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
29 September 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 08/09/2026)
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
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