EU Veterinary Vaccine and Pharmacovigilance Training Courses Target Regulatory Gaps Under Regulation (2019/6)
核心洞察
IPI Academy (搜索) will run a two-day online course on veterinary vaccine development and registration in the EU on March 9-10, 2027, carrying 12 CPD hours.
A companion advanced veterinary pharmacovigilance course runs November 4-5, 2026, addressing EU Regulation (2019/6) and Veterinary Good Pharmacovigilance Practices obligations.
The pharmacovigilance programme covers Pharmacovigilance System Master File documentation, signal detection under EU and VMD frameworks, and audit and inspection readiness.
Professionals working on veterinary biologics will have two structured opportunities to strengthen their grasp of European regulatory requirements, with IPI Academy (搜索) scheduling an online veterinary vaccine development and registration course for March 9–10, 2027, and an advanced veterinary pharmacovigilance course for November 4–5, 2026. Both programmes have been added to ResearchAndMarkets.com (搜索)'s offering and each carries 12 CPD hours.
Vaccine Development and Registration Pathway
The two-day vaccine course, "A Practical Approach to Veterinary Vaccine Development and Registration in the EU," runs online from 08:30 to 15:30 GMT and addresses the complex requirements involved in developing veterinary vaccines and achieving market authorisation in the EU. Organisers frame the programme around practical advice and guidance, taking participants step by step through the development and registration process.
With demand for biologics in veterinary medicine increasing, the curriculum focuses on the regulatory, quality, safety and efficacy considerations that must be addressed when bringing veterinary vaccines toward market approval. Content includes a practical guide to the EU regulatory framework for veterinary vaccines, procedures aimed at promoting vaccine availability, and detailed consideration of marketing authorisation dossier requirements covering quality, safety and efficacy.
Participants will also explore the use of the Summary of Product Characteristics (SPC) as a development tool, vaccine development planning, regulatory advice for novel vaccines, dossier preparation and submission, and European licensing procedures and regulatory strategy. A dedicated workshop allows delegates to apply the requirements in practice, followed by group reporting and Q&A, with discussion time intended to facilitate engagement with expert faculty and fellow professionals.
Advanced Pharmacovigilance Under Regulation (2019/6)
The pharmacovigilance course is positioned as a follow-on for professionals who already have some experience in the field, building on introductory-level knowledge rather than repeating it. Organisers note that EU Regulation (2019/6) on Veterinary Medicinal Products is reshaping pharmacovigilance obligations, and the programme examines that regulation alongside Veterinary Good Pharmacovigilance Practices (VGVP) and the implications of The Veterinary Medicines (Amendment etc.) Regulations 2024.
The two-day agenda moves from documentation and compliance into detection and response. Day one covers the Pharmacovigilance System Master File (PSMF) and its appendices, pharmacovigilance training, product safety reviews, company core safety information, compliance considerations, and PV reporting in licensing and distribution agreements. Day two shifts to signal detection requirements under both EU and VMD frameworks, an EV Vet DWH demonstration, signal detection combined with benefit-risk and risk management, audits and inspection readiness, and risk management when dealing with an active alert.
Sessions are delivered live and interactively, with delegates sharing current challenges and receiving guidance intended for immediate application in day-to-day work. The course can be counted toward QPPV or deputy QPPV training, adding a formal credentialing pathway to the practical content.
Faculty and Target Audience
Training is led by Declan O'Rourke, a veterinary surgeon with over 20 years of industry experience across technical, clinical development and pharmacovigilance roles. He holds a Diploma in Marketing, an MBA and a Fellowship of the Royal College of Veterinary Surgeons, directs Ortec PV Consultancy Ireland (搜索), and represented IFAH-EU in the VICH Working Group on pharmacovigilance. He is also Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School (搜索) and a past president of the British Cattle Veterinary Association.
The pharmacovigilance course is aimed at professionals with some existing experience, including adverse event monitoring and drug safety officers, QPPVs and deputy QPPVs, and personnel from regulatory affairs and registration departments. Organisers describe it as a structured stepping stone for organisations building pharmacovigilance capability, and as the logical next step for teams that have completed introductory-level training and need deeper technical and regulatory grounding for compliant, inspection-ready operations.