Introduzione
Introduction to Veterinary Pharmacovigilance
Mastery of the regulatory landscape governing veterinary pharmacovigilance stands as a fundamental prerequisite for professionals entering this specialized field. Every individual engaged directly or indirectly in pharmacovigilance operations within any organization must receive appropriate training and demonstrate proficiency in executing their designated responsibilities.
This intensive 8-hour program delivers a thorough foundation in veterinary pharmacovigilance, bridging conceptual knowledge with hands-on application. Rather than offering only theoretical overview, this training prioritizes practical skill development through authentic case studies, interactive exercises, and systematic competency-building activities.
The program's objective is to equip participants with comprehensive theoretical grounding alongside operational proficiency in veterinary pharmacovigilance. Core topics encompass adverse event identification and documentation, pharmacovigilance system master file (PSMF) management, regulatory inspection readiness, integration of pharmacovigilance workflows into quality assurance frameworks, and competence in digital platforms such as Eudra Vet, EVVET, Union Pharmacovigilance Database, and IRIS.
Participants will develop practical capabilities through causality evaluation exercises, VeDDRA terminology workshops, EV Vet system demonstrations, and comprehensive case analyses.
Programme
DAY 1: Foundations, Framework & Adverse Event Management
Introduction & Regulatory Landscape
- What is Veterinary Pharmacovigilance? Importance and scope
- Key definitions and terminology
- EU Regulation and UK VMR (Veterinary Medicines Regulations) overview
- VICH guidelines (GL24, GL35, GL42) – global harmonization
- Regulatory authorities: EMA, NCAs, VMD roles and responsibilities
- Marketing Authorization Holder (MAH), QPPV, and EMA/NCA obligations
Adverse Event Identification & Reporting
- ICSR (Individual Case Safety Report) requirements and standards
- Types of adverse events: animal, human, environmental, lack of efficacy
- Regulatory timelines
- Minimum reporting criteria
- EVVet system
- International perspective: CVM (USA), VDD (Canada), APVMA (Australia)
Causality Assessment & Case Evaluation
- Principles of causality assessment and categories
- VeDDRA (Veterinary Dictionary for Drug Related Affairs) structure and application
- Case processing workflow
- Temporal relationship, dechallenge, rechallenge evaluation
- Follow-up strategies
- Documentation requirements and best practices
- Case Studies
DAY 2: Systems, Compliance & Quality Management
Electronic Systems & Data Management
- Union Pharmacovigilance Database/EVVet
- IRIS: adverse event repository management
- System integration and validation
Pharmacovigilance Infrastructure
- Pharmacovigilance System Master File (PSMF)
- Quality Management System (QMS) Integration
- SOPs for pharmacovigilance activities
Signal Detection & Risk Management
- Signal detection principles and methodologies
- Conducting benefit-risk evaluations
- Statistical concepts for signal identification (basic overview)
- Prioritization and validation of signals
- Risk minimization measures and communication strategies
- Summary reports for regulatory authorities and annual statements
- Individuals new to veterinary pharmacovigilance seeking comprehensive foundational training
- Pharmaceutical professionals transitioning to veterinary PV roles
- Veterinary pharmaceutical professionals planning to undertake QPPV and/or Deputy QPPV roles
- Support staff needing to understand their role in drug safety operations
- Quality assurance and regulatory affairs professionals involved in PV activities
- Veterinaries in industry pharmacovigilance roles
- Experienced personnel seeking deeper understanding and practical skills in veterinary PV
Participant experience
- No prior pharmacovigilance experience required
- Basic understanding of veterinary medicine or pharmaceutical industry is beneficial but not mandatory
- Participants should have professional interest in drug safety and regulatory compliance
Interactive training including practical session, discussion and Q&A
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 – 2 modules
Module 1 | 09 April 2026 from 2:00 pm to 6:00 pm CEST
Module 2 | 14 April 2026 from 2:00 pm to 6:00 pm CEST
Some 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: € 895,00* (until 19 March 2026)
Ordinary: € 1.095,00*
Freelance – Individual – Academy – Public Administration: € 640,00*
* 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.
