Introductory EU Veterinary Drug Safety Course (Mar 2026)
The “Introduction to Veterinary Pharmacovigilance Training Course (March 9–10, 2026)” has been added to the growing portfolio of professional training programs available through ResearchAndMarkets.com. This comprehensive two-day course is designed to deliver a practical, structured introduction to veterinary pharmacovigilance, providing essential guidance for professionals involved in drug safety across the European Union and beyond.
As regulatory expectations continue to evolve and scrutiny around veterinary medicinal products intensifies, pharmacovigilance has become a critical function within animal health organizations. This training course responds directly to industry needs by offering a clear, accessible overview of veterinary pharmacovigilance principles, regulatory obligations, and real-world implementation challenges. It is particularly suited to professionals who are new to the discipline, as well as experienced staff seeking to strengthen or refresh their understanding of EU veterinary drug safety requirements.
Practical, Interactive Training for Real-World Application
The two-day program has been carefully structured to balance regulatory theory with practical application. Participants will be guided through the fundamentals of veterinary pharmacovigilance, including adverse event reporting, causality assessment, data quality management, and regulatory compliance. Throughout the course, attendees will benefit from interactive discussions, question-and-answer sessions, and industry-based case studies that demonstrate how pharmacovigilance principles are applied in real-life scenarios.
Led by an experienced industry professional, the training aims to demystify what is often perceived as a complex regulatory area. The trainer will clarify commonly used terminology, explain roles and responsibilities within pharmacovigilance systems, and provide insight into how regulatory authorities interpret and assess safety data. This approach ensures participants not only understand the regulatory framework but are also better equipped to apply that knowledge in their daily roles.
Who Should Attend
The course is particularly valuable for individuals who are new to veterinary pharmacovigilance and require a solid foundation in drug safety. It is also highly relevant for support staff and experienced professionals who interact with pharmacovigilance activities as part of their broader responsibilities.
Recommended attendees include adverse event monitoring personnel, drug safety officers, regulatory affairs professionals, and staff working in registration or post-marketing surveillance departments. Veterinarians involved in clinical development, medical affairs, or safety reporting will also find the content highly applicable. By catering to a broad professional audience, the course encourages cross-functional understanding of pharmacovigilance responsibilities within veterinary organizations.
Key Benefits of Attending
Participants attending the course will gain a wide range of practical and regulatory insights, including:
- A comprehensive overview of the European veterinary regulatory framework
- A clear understanding of EU pharmacovigilance legislation and compliance requirements
- Insight into the role and impact of VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)
- Detailed guidance on adverse event reporting processes
- An introduction to causality assessment and medical evaluation of safety reports
- Strategies to minimize the impact of incomplete or erroneous data
- Best practices for conducting pharmacovigilance literature searches
- An understanding of UK veterinary pharmacovigilance requirements following Brexit
These benefits are designed to help organizations improve compliance, enhance data quality, and strengthen their overall approach to veterinary drug safety.
Certification and Continuing Professional Development
Upon completion of the training, participants will receive a certificate of completion, confirming their participation in the course. In addition, the training qualifies for 12 hours of Continuing Professional Development (CPD), allowing attendees to formally record their learning and development activities.
Detailed Agenda Overview
The course agenda is divided into two structured days, each focusing on key aspects of veterinary pharmacovigilance.
Day 1: Foundations of Veterinary Pharmacovigilance
The first day begins with an introduction to pharmacovigilance and its role in ensuring the safe and effective use of veterinary medicinal products. Participants will explore both the beneficial and harmful effects of veterinary medicines, supported by clear definitions and regulatory context.
Topics covered include:
- The fundamental principles of pharmacovigilance
- Key terminology used in veterinary drug safety
- The current European regulatory framework and its global implications
The course then provides a detailed overview of EU pharmacovigilance legislation, highlighting its interaction with global standards and VICH guidelines. Practical applications of regulatory definitions are discussed, helping participants understand how these concepts are applied in day-to-day pharmacovigilance activities.
Roles and responsibilities within the pharmacovigilance system are clearly defined, including:
- The role of the Marketing Authorisation Holder (MAH)
- The responsibilities of National Competent Authorities (NCAs) and the European Medicines Agency (EMA)
- The critical function of the Qualified Person for Pharmacovigilance (QPPV)
Adverse event reporting is examined in depth, with sessions covering definitions, reporting timelines, and the influence of VICH guidelines. Participants will learn the difference between expedited and periodic reporting and gain practical guidance on handling suspected adverse reactions (SARs) in animals and humans.
The day concludes with a focused session on causality assessment, exploring the principles behind evaluating the relationship between medicinal products and reported adverse events. Practical examples are used to demonstrate medical evaluation techniques, follow-up strategies, and the importance of identifying a valid reporter.
Day 2: Systems, Data Quality, and Regulatory Compliance
The second day builds on the foundational knowledge from Day 1 and focuses on pharmacovigilance systems, data management, and international regulatory requirements.
Sessions begin with an exploration of veterinary reporting behavior, examining whether veterinarians report adverse events and the factors that influence reporting practices. This is followed by a detailed look at electronic communication in pharmacovigilance, including reporting systems such as EV Vet and the use of VEDDRA terminology. A practical demonstration of EV Vet reporting is included to enhance understanding.
Data quality management is a central theme of Day 2. Participants will learn strategies for minimizing the impact of data errors through consistent assessment, accurate coding, and effective quality control processes. Clinical trial adverse event reporting requirements are also discussed, providing insight into safety obligations during development phases.
Further topics include:
- Post-authorisation safety studies
- Phase IV study requirements
- Best practices for pharmacovigilance literature searches
The literature search session covers peer-reviewed global publications as well as local journals and magazines, highlighting their importance in ongoing safety surveillance.
The course concludes with an in-depth examination of Periodic Safety Update Reports (PSURs). Participants will gain insight into regulatory requirements from authorities such as the UK Veterinary Medicines Directorate (VMD), Canada’s Veterinary Drugs Directorate (VDD), and Australia’s APVMA. Topics include PSUR format and content, data analysis, incidence calculation, and strategies for maintaining compliance.
Expert Speaker
The course is led by Declan O’Rourke, Director of Ortec PV Consultancy Ireland, a recognized expert in veterinary pharmacovigilance with over 20 years of industry experience. His career spans technical, marketing, product development, clinical development, production, and pharmacovigilance roles, providing him with a uniquely broad perspective on veterinary medicines.
Declan O’Rourke is a qualified veterinary surgeon and holds a Diploma in Marketing, a Master of Business Administration, and a Fellowship of the Royal College of Veterinary Surgeons. He has represented IFAH-EU in the VICH Working Group on Pharmacovigilance and currently serves as Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School. He is also a Past President of the British Cattle Veterinary Association.
A Valuable Investment in Veterinary Drug Safety
This introductory training course offers a valuable opportunity for professionals to build confidence and competence in veterinary pharmacovigilance. By combining regulatory clarity, practical guidance, and expert insight, the program supports organizations in meeting compliance obligations while contributing to the safe and effective use of veterinary medicinal products.
For professionals working in animal health, regulatory affairs, or drug safety, this course represents a practical and timely investment in knowledge, skills, and professional development.
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